Cost-effect analysis of the PET-CT system. Analysis in the clinical ...
Cost-effect analysis of the PET-CT system. Analysis in the clinical ...
Cost-effect analysis of the PET-CT system. Analysis in the clinical ...
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<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g Incremental <strong>Cost</strong>-<br />
Effectiveness Ratio<br />
(ICER)<br />
HEALTH TECHNOLOGY ASSESSMENT (HTA) REPORT<br />
commissioned by<br />
Agency for Health Technology Assessment <strong>in</strong> Poland<br />
performed by<br />
Institute <strong>of</strong> Public Health and Social Insurance<br />
Bus<strong>in</strong>ess College<br />
National-Louis University<br />
Warsaw – Nowy Sącz 2006
PRINCIPAL<br />
HEALTH TECHNOLOGY ASSESSMENT AGENCY<br />
Al. Lotników No. 22, 02-668 Warsaw<br />
tel. +48 22 5667200<br />
fax +48 22 5667202<br />
www.aotm.gov.pl<br />
CONTRA<strong>CT</strong>OR<br />
INSTITUTE OF PUBLIC HEALTH AND SOCIAL INSURANCE<br />
BUSINESS COLLEGE<br />
NATIONAL-LOUIS UNIVERSITY<br />
Zielona St. No. 27, 33-300 Nowy Sącz<br />
tel. +48 18 4499120<br />
fax +48 18 4499121<br />
e-mail. wsb-nlu@wsb-nlu.edu.pl<br />
www.wsb-nlu.edu.pl<br />
2
THIS REPORT WAS ASSISSTED BY SPECIALISTS FROM<br />
CENTRE OF ONCOLOGY - MARIA SKŁODOWSKA –CURIE MEMORIAL INSTITUTE<br />
Pr<strong>of</strong>. Marek Nowacki MD, PhD<br />
Pr<strong>of</strong>. Witold Bartnik MD, PhD<br />
Associate Pr<strong>of</strong>. Mariusz Bidziński MD, PhD<br />
Associate Pr<strong>of</strong>. Andrzej Kawecki MD, PhD<br />
Associate Pr<strong>of</strong>. Włodzimierz Ruka MD, PhD<br />
Associate Pr<strong>of</strong>. Jan Walewski MD, PhD<br />
Wiesław Lasota MD, PhD<br />
Janusz Meder MD, PhD<br />
Andrzej Pietraszek MD, PhD<br />
Piotr Siedlecki MD, PhD<br />
Piotr Rutkowski MD, PhD<br />
INSTITUTE OF PULMONARY DISEASES AND TUBERCULOSIS IN WARSAW<br />
Pr<strong>of</strong>. Kazimierz Roszkowski-ŚliŜ MD, PhD<br />
3
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
TABLE OF CONTENTS<br />
1. SUMMARY............................................................................................................................................... 6<br />
2. HEAD AND NECK MALIGNANT NEOPLASMS – COST-EFFE<strong>CT</strong>IVENESS ANALYSIS –<strong>PET</strong>-<strong>CT</strong> vs<br />
<strong>CT</strong> DIAGNOSTICS ................................................................................................................................................ 7<br />
2.1. METASTASES DETE<strong>CT</strong>ION ................................................................................................................ 7<br />
2.1.1. Model description............................................................................................................................ 7<br />
2.1.2. Model’s transient states................................................................................................................... 8<br />
2.1.3. <strong>Cost</strong>s calculation ............................................................................................................................. 9<br />
2.1.4. Model parameters.......................................................................................................................... 12<br />
2.1.5. Results........................................................................................................................................... 14<br />
2.1.6. Sensitivity <strong>analysis</strong>........................................................................................................................ 15<br />
2.2. Recurrences diagnostics............................................................................................................. 18<br />
2.2.1. Model description.......................................................................................................................... 18<br />
2.2.2. Model transient states.................................................................................................................... 18<br />
2.2.3 <strong>Cost</strong>s calculation ........................................................................................................................... 19<br />
2.2.4 Model parameters.......................................................................................................................... 23<br />
2.2.5. Results........................................................................................................................................... 24<br />
2.2.6. Sensitivity <strong>analysis</strong>........................................................................................................................ 26<br />
2.3. PRIMARY TUMOR DETE<strong>CT</strong>ION IN CASE OF CERVICAL LYMPH NODES METASTASES<br />
FROM THE UNKNOWN PRIMARY ORIGIN SQUAMOUS CELL CARCINOMA ................................... 29<br />
2.3.1. Model description.......................................................................................................................... 29<br />
2.3.2. Model’s transient states................................................................................................................. 29<br />
2.3.3. <strong>Cost</strong>s calculation ........................................................................................................................... 30<br />
2.3.4. Model parameters.......................................................................................................................... 34<br />
2.3.5. Results........................................................................................................................................... 36<br />
2.3.6. Sensitivity <strong>analysis</strong>........................................................................................................................ 37<br />
2.4. LITERATURE....................................................................................................................................... 40<br />
3. NON-SMALL CELL LUNG CANCER – COST-EFFE<strong>CT</strong>IVENESS ANALYSIS – <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
DIAGNOSTICS .................................................................................................................................................... 41<br />
3.1. Model description......................................................................................................................... 41<br />
3.2. Model’s transient states............................................................................................................... 42<br />
3.3. <strong>Cost</strong>s calculation .......................................................................................................................... 45<br />
3.4. Model parameters........................................................................................................................ 48<br />
3.5. Results............................................................................................................................................... 52<br />
3.6. Sensitivity <strong>analysis</strong>.......................................................................................................................... 54<br />
3.7. LITERATURE....................................................................................................................................... 58<br />
4. GASTROINTESTINAL STROMAL TUMORS (GIST) – COST-EFFE<strong>CT</strong>IVENESS ANALYSIS –<strong>PET</strong>-<strong>CT</strong><br />
vs <strong>CT</strong> DIAGNOSTICS ......................................................................................................................................... 60<br />
4.1. Model description......................................................................................................................... 60<br />
4.2. Model’s transient states............................................................................................................... 61<br />
4.3. <strong>Cost</strong>s calculation .......................................................................................................................... 62<br />
4.4. Model parameters........................................................................................................................ 64<br />
4.5. Results............................................................................................................................................... 65<br />
4.6. Sensitivity <strong>analysis</strong>.......................................................................................................................... 67<br />
4.7. LITERATURE....................................................................................................................................... 70<br />
5. UNKNOWN PRIMARY ORIGIN DETE<strong>CT</strong>ION IN CASE OF CERVICAL LYMPH NODES<br />
INVOLVEMENT BY THE SQUAMOUS CELL CANCER – COST-EFFE<strong>CT</strong>IVENESS ANALYSIS – <strong>PET</strong>-<strong>CT</strong> VS<br />
<strong>CT</strong> ................................................................................................................................................................ 71<br />
5.1. Model description......................................................................................................................... 71<br />
5.2. Model’s transient states............................................................................................................... 72<br />
5.3. <strong>Cost</strong>s calculation .......................................................................................................................... 73<br />
5.4. Model parameters........................................................................................................................ 76<br />
5.5. Results............................................................................................................................................... 78<br />
5.6. Sensitivity <strong>analysis</strong>.......................................................................................................................... 80<br />
5.7. LITERATURE....................................................................................................................................... 83<br />
6. OVARIAN CANCER – COST-comparison ANALYSIS – <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong>....................................... 84<br />
4
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
6.1. <strong>Cost</strong>s calculation .......................................................................................................................... 84<br />
6.2. Results............................................................................................................................................... 86<br />
7. OESOPHAGEAL CANCER – COST-comparison ANALYSIS – <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> VE EUS-FNA..... 87<br />
7.1. <strong>Cost</strong>s calculation .......................................................................................................................... 87<br />
7.2. Results............................................................................................................................................... 89<br />
8. LYMPHOMAS – COST-COMPARISON ANALYSIS – <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong>.............................................. 91<br />
8.1. <strong>Cost</strong>s calculation .......................................................................................................................... 91<br />
8.2. Results............................................................................................................................................... 93<br />
9. THYROID CANCER – COST-COMPARISON ANALYSIS – <strong>PET</strong>-<strong>CT</strong> vs WHOLE-BODY<br />
SCINTIGRAPHY................................................................................................................................................... 94<br />
9.1. <strong>Cost</strong>s calculation .......................................................................................................................... 94<br />
9.2. Results............................................................................................................................................... 96<br />
10. PANCREATIC CANCER – COST-COMPARISON ANALYSIS – <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> ............................ 97<br />
10.1. <strong>Cost</strong>s calculation .......................................................................................................................... 97<br />
10.2. Results............................................................................................................................................... 99<br />
11. COLON CANCER - no <strong>analysis</strong> - <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> .......................................................................... 100<br />
12. DISCUSSION ....................................................................................................................................... 101<br />
13. LIST OF TABLES ................................................................................................................................... 103<br />
14. LIST OF FIGURES................................................................................................................................. 107<br />
5
1. SUMMARY<br />
The aim <strong>of</strong> this report is a comparative cost-<br />
<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> technology (positron<br />
emission tomography - <strong>PET</strong> fused with computed<br />
tomography - <strong>CT</strong>) and <strong>the</strong> diagnostic technologies<br />
f<strong>in</strong>anced from public sources <strong>in</strong> oncological diagnostics<br />
<strong>in</strong> Poland. The efficacy <strong>of</strong> <strong>the</strong> compared diagnostic<br />
methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical part <strong>of</strong> <strong>the</strong> report,<br />
entitled “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong><br />
positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic<br />
technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets<br />
<strong>in</strong> <strong>the</strong> oncologic diagnostics - epidemiological and<br />
cl<strong>in</strong>ical part”. That part <strong>in</strong>cludes particular description <strong>of</strong><br />
populations, <strong>in</strong>tervention, compartors, outcomes, used<br />
studies design and results (accuracy <strong>of</strong> compared<br />
diagnostic tests).<br />
The study was prepared for <strong>the</strong> Agency for Health<br />
Technology Assessment <strong>in</strong> Poland.<br />
Only <strong>in</strong>dications with statistically significant differences<br />
<strong>of</strong> compared methods diagnostic efficacy were<br />
<strong>in</strong>cluded <strong>in</strong>to <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong>.<br />
Cl<strong>in</strong>ical <strong>effect</strong>s were estimated on a basis <strong>of</strong> available<br />
data from studies and experts’ estimations.<br />
<strong>Cost</strong>s, from <strong>the</strong> Polish public payer’s perspective were<br />
estimated on a basis <strong>of</strong> <strong>the</strong> available data concern<strong>in</strong>g<br />
procedures used <strong>in</strong> particular <strong>in</strong>dications, <strong>in</strong> a time<br />
horizon equal to patients’ life expectancy.<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong>, us<strong>in</strong>g ICER ratio, was<br />
performed <strong>in</strong> <strong>the</strong> follow<strong>in</strong>g <strong>in</strong>dications:<br />
• head and neck malignant neoplasms<br />
metastases diagnostics, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>system</strong> is<br />
more expensive, but more <strong>effect</strong>ive than<br />
computed tomography diagnostics –<br />
<strong>in</strong>cremental cost-<strong>effect</strong>iveness ratio (ICER)<br />
amounts 8,100.09 PLN/LYG;<br />
• head and neck malignant neoplasms<br />
recurrence diagnostics, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>system</strong> is<br />
more expensive, but more <strong>effect</strong>ive than<br />
computed tomography diagnostics –<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
<strong>in</strong>cremental cost-<strong>effect</strong>iveness ratio (ICER)<br />
amounts 33,016.54 PLN/LYG;<br />
• unknown primary orig<strong>in</strong> <strong>of</strong> head and neck<br />
malignant neoplasms diagnostics, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong><br />
<strong>system</strong> is more expensive, but more <strong>effect</strong>ive<br />
than computed tomography diagnostics –<br />
<strong>in</strong>cremental cost-<strong>effect</strong>iveness ratio (ICER)<br />
amounts 38,322.77 PLN/LYG;<br />
• non-small cell lung cancer stag<strong>in</strong>g, us<strong>in</strong>g <strong>PET</strong>-<br />
<strong>CT</strong> <strong>system</strong> is more expensive, but more<br />
<strong>effect</strong>ive than computed tomography<br />
diagnostics – <strong>in</strong>cremental cost-<strong>effect</strong>iveness<br />
ratio (ICER) amounts 152,862.22 PLN/LYG;<br />
• assessment <strong>of</strong> GIST response to imat<strong>in</strong>ib<br />
<strong>the</strong>rapy, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>system</strong> is more expensive,<br />
but more <strong>effect</strong>ive than computed<br />
tomography diagnostics – <strong>in</strong>cremental cost-<br />
<strong>effect</strong>iveness ratio (ICER) amounts 159,626.51<br />
PLN/LYG;<br />
• primary tumor <strong>of</strong> unknown primary orig<strong>in</strong><br />
malignant neoplasms diagnostics, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong><br />
<strong>system</strong> is more expensive, but more <strong>effect</strong>ive<br />
than computed tomography diagnostics –<br />
<strong>in</strong>cremental cost-<strong>effect</strong>iveness ratio (ICER)<br />
amounts 14,125.67 PLN/LYG;<br />
In all mentioned above <strong>in</strong>dications, <strong>the</strong> diagnostic<br />
efficacy differences <strong>of</strong> compared methods lead to<br />
differences <strong>of</strong> cl<strong>in</strong>ical efficacy and treatment costs. <strong>PET</strong>-<br />
<strong>CT</strong> was more <strong>effect</strong>ive and simultaneously more<br />
expensive diagnostic method than o<strong>the</strong>r compared<br />
techniques.<br />
In case <strong>of</strong> ovarian cancer, oesophageal cancer,<br />
lymphomas and pancreatic cancer, <strong>the</strong> cost<br />
comparison <strong>analysis</strong> was performed, due to <strong>the</strong> lack <strong>of</strong><br />
possibility to perform <strong>the</strong> <strong>analysis</strong> us<strong>in</strong>g <strong>the</strong> ICER ratio.<br />
<strong>PET</strong>-<strong>CT</strong> method, revealed <strong>in</strong> all cases to be more<br />
expensive than o<strong>the</strong>r compared diagnostic procedures.<br />
In colon cancer diagnostics available data was<br />
<strong>in</strong>sufficient for any <strong>analysis</strong>.<br />
6
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
2. HEAD AND NECK MALIGNANT NEOPLASMS – COST-<br />
EFFE<strong>CT</strong>IVENESS ANALYSIS –<strong>PET</strong>-<strong>CT</strong> VS <strong>CT</strong> DIAGNOSTICS<br />
In <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong>, compar<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> <strong>in</strong> diagnostic <strong>of</strong> head and neck<br />
malignant neoplasms, three decision models were used, concern<strong>in</strong>g <strong>the</strong> follow<strong>in</strong>g <strong>in</strong>dications:<br />
• distant metastases diagnostics <strong>in</strong> <strong>the</strong> primary head and neck malignant neoplasms<br />
stag<strong>in</strong>g – patients from <strong>the</strong> high-risk group <strong>of</strong> <strong>the</strong> generalized disease;<br />
• follow-up diagnostics after <strong>the</strong> head and neck malignant neoplasms treatment,<br />
aim<strong>in</strong>g to detect <strong>the</strong> possible disease recurrences;<br />
• diagnostics performed <strong>in</strong> case <strong>of</strong> lymph nodes <strong>in</strong>volvement by <strong>the</strong> squamous cell<br />
carc<strong>in</strong>oma: detection <strong>of</strong> <strong>the</strong> unknown primary orig<strong>in</strong> <strong>of</strong> <strong>the</strong> neoplasm.<br />
The efficacy <strong>of</strong> <strong>the</strong> compared diagnostic methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical part <strong>of</strong> <strong>the</strong><br />
report, entitled “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<br />
<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic<br />
diagnostics - epidemiological and cl<strong>in</strong>ical part”. Cl<strong>in</strong>ical <strong>effect</strong>s were estimated on a basis <strong>of</strong><br />
available data from studies or experts’ estimations. <strong>Cost</strong>s, from <strong>the</strong> Polish public payer’s<br />
perspective were estimated on a basis <strong>of</strong> <strong>the</strong> available data concern<strong>in</strong>g procedures used <strong>in</strong><br />
particular <strong>in</strong>dications, <strong>in</strong> a time horizon equal to patients’ life expectancy.<br />
2.1. METASTASES DETE<strong>CT</strong>ION<br />
2.1.1. Model description<br />
Model utilized <strong>in</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> concerns a group <strong>of</strong> patients with head and<br />
neck malignant neoplasm, with a high risk, estimated on a basis <strong>of</strong> <strong>the</strong> prelim<strong>in</strong>ary cl<strong>in</strong>ical<br />
assessment, <strong>of</strong> distant metastases. <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> diagnostics <strong>effect</strong>s and costs were<br />
compared. Decision model, us<strong>in</strong>g a TreeAge ® 2004 (version 7) s<strong>of</strong>tware, was used <strong>in</strong> <strong>the</strong><br />
<strong>analysis</strong>. Time horizon was estimated until patient’s death, cost data were estimated from <strong>the</strong><br />
public payer’s perspective, on a basis <strong>of</strong> available <strong>in</strong>formation. The efficacy <strong>of</strong> <strong>the</strong> compared<br />
diagnostic methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical part <strong>of</strong> <strong>the</strong> report, entitled “Comparative cost<br />
– <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies<br />
f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics - epidemiological and<br />
cl<strong>in</strong>ical part”. Data concern<strong>in</strong>g <strong>the</strong> treatment <strong>effect</strong>s and consequences <strong>of</strong> <strong>the</strong> improper<br />
7
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
treatment, result<strong>in</strong>g from <strong>the</strong> misdiagnos<strong>in</strong>g, were obta<strong>in</strong>ed from <strong>the</strong> literature or from experts'<br />
estimation, <strong>in</strong> case <strong>of</strong> unavailable data.<br />
Information concern<strong>in</strong>g <strong>effect</strong>iveness <strong>of</strong> <strong>the</strong> diagnostic test to obta<strong>in</strong> correct estimation <strong>of</strong><br />
<strong>the</strong> patient as well as data concern<strong>in</strong>g diagnostic errors were <strong>in</strong>corporated <strong>in</strong>to <strong>the</strong> model.<br />
Improper diagnostics may cause health or f<strong>in</strong>ancial losses.<br />
2.1.2. Model’s transient states<br />
Decision model conta<strong>in</strong>s <strong>the</strong> follow<strong>in</strong>g transient states (equal for both variants <strong>of</strong> <strong>the</strong><br />
diagnostic procedure):<br />
• “Head and neck neoplasms” is a basel<strong>in</strong>e state, characteriz<strong>in</strong>g patients population<br />
at <strong>the</strong> beg<strong>in</strong>n<strong>in</strong>g <strong>of</strong> treatment. After <strong>the</strong> diagnostic procedure, <strong>the</strong>re is a possibility to<br />
pass <strong>in</strong>to <strong>the</strong> follow<strong>in</strong>g states:<br />
o Diagnosis: metastases (<strong>in</strong> case when <strong>the</strong> procedure revealed metastases);<br />
o Diagnosis: no metastases (if <strong>the</strong>re were no signs <strong>of</strong> metastases).<br />
• “Diagnosis: metastases” – conta<strong>in</strong>s patients with diagnosed metastases <strong>of</strong> <strong>the</strong> head<br />
and neck malignant neoplasms. If <strong>the</strong> metastases are diagnosed, <strong>the</strong> two f<strong>in</strong>al states<br />
may occur:<br />
o Patients with metastases (<strong>in</strong> case <strong>of</strong> <strong>the</strong> correct diagnosis <strong>of</strong> metastases);<br />
o Patient without metastases (if <strong>the</strong> metastases were <strong>in</strong>correctly diagnosed).<br />
• “Diagnosis: no metastases” – this state conta<strong>in</strong>s patients without diagnosed<br />
metastases <strong>of</strong> <strong>the</strong> head and neck malignant neoplasms. If no metastases were<br />
diagnosed, <strong>the</strong>re is a possibility to pass <strong>in</strong>to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Patient with metastases (if <strong>the</strong> diagnosis <strong>of</strong> lack <strong>of</strong> metastases was <strong>in</strong>correct);<br />
o Patient without metastases (if <strong>the</strong> lack <strong>of</strong> metastases was correctly<br />
diagnosed).<br />
The follow<strong>in</strong>g figure shows <strong>the</strong> illustration <strong>of</strong> <strong>the</strong> decision tree, describ<strong>in</strong>g <strong>the</strong> course <strong>of</strong><br />
metastases detection, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> and computed tomography. Ma<strong>in</strong> model parameters are<br />
shown <strong>in</strong> <strong>the</strong> table below.<br />
8
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Figure 1.<br />
Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> <strong>the</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison, used <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong><br />
head and neck malignant neoplasms metastases (legend – table 6)<br />
As presented <strong>in</strong> <strong>the</strong> figure 1, it is assumed that all patients with positive result <strong>of</strong> diagnostic<br />
tests had palliative treatment, patients with true negative result had surgical treatment, and<br />
patients with false negative results had both surgical and palliative treatments.<br />
2.1.3. <strong>Cost</strong>s calculation<br />
In <strong>the</strong> studies concern<strong>in</strong>g head and neck malignant neoplasms, <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> method was<br />
compared to <strong>the</strong> computed tomography with contrast media (<strong>CT</strong>). Computed tomography<br />
(<strong>CT</strong>) <strong>of</strong> <strong>the</strong> head is an out-patient, co-f<strong>in</strong>anced (ASDW) diagnostic service, that amounts 28<br />
po<strong>in</strong>ts – 23 po<strong>in</strong>ts are refunded by <strong>the</strong> National Health Fund and <strong>the</strong> 5 rema<strong>in</strong><strong>in</strong>g po<strong>in</strong>ts are<br />
covered by a physician referr<strong>in</strong>g to <strong>the</strong> procedure (“Catalogue <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced out-<br />
patient diagnostic procedures ranges (ASDW)”. The attachment No 1b, to <strong>the</strong> AOS<br />
<strong>in</strong>formational materials). Referrer covers <strong>the</strong> cost <strong>of</strong> performed procedure, accord<strong>in</strong>g to <strong>the</strong><br />
negotiated price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t. The National Health Fund covers <strong>the</strong> cost <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced<br />
diagnostic procedure, accord<strong>in</strong>gly to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by: health care<br />
provider perform<strong>in</strong>g <strong>the</strong> procedure and by <strong>the</strong> referrer.<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on<br />
<strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories hav<strong>in</strong>g <strong>the</strong> contract<br />
with <strong>the</strong> National Health Fund <strong>in</strong> Poland, amounts 8.05 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> service from <strong>the</strong> ASDW catalogue,<br />
toge<strong>the</strong>r with its cost calculation.<br />
9
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 1.<br />
Service characteristics and <strong>the</strong> head computed tomography cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
with contrast media<br />
Name and code <strong>of</strong><br />
<strong>the</strong> procedure<br />
<strong>CT</strong>: <strong>CT</strong> <strong>of</strong> <strong>the</strong> head<br />
with contrast media<br />
5.03.00.0000025<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
<strong>CT</strong> laboratory Oncologic<br />
dispensary<br />
Test<br />
cost<br />
(PLN)<br />
23 5 8,05 7,54 222,85<br />
<strong>PET</strong>-<strong>CT</strong> is an <strong>in</strong>dividually contracted service, amount<strong>in</strong>g 420 po<strong>in</strong>ts. The average price <strong>of</strong><br />
<strong>the</strong> settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz,<br />
<strong>the</strong> sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Table 2.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
Test cost [PLN]<br />
420 10,75 4 515,00<br />
The average <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> head and neck malignant<br />
neoplasm amounts 222.85 PLN, and <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong> public payer’s<br />
perspective – amounts 4,515.00 PLN.<br />
The follow<strong>in</strong>g table shows selected items, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services, used to<br />
calculate <strong>the</strong> costs <strong>of</strong> 6 cycles <strong>of</strong> chemo<strong>the</strong>rapy or 6 months <strong>of</strong> palliative chemo<strong>the</strong>rapy.<br />
Table 3.<br />
<strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies, from <strong>the</strong> NHF services catalogue, used <strong>in</strong> head and neck malignant neoplasms<br />
treatment<br />
Type <strong>of</strong> <strong>the</strong><br />
<strong>the</strong>rapy<br />
PF<br />
Active substances Posology<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
100 mg/m 2 iv / day 1 // 800–1000 mg/m 2 iv<br />
days 1–4 (CONTINUOUS INFUSION 96 H<br />
WITH/WITHOUT RADIOTHERAPY)<br />
Code=No <strong>of</strong><br />
po<strong>in</strong>ts x po<strong>in</strong>t<br />
price (10 PLN)<br />
[PLN]<br />
7 148,40<br />
MTX METHOTREXATUM 40 mg/m 2 iv day 1, every 7 days 3 098,40<br />
10
PFH&N<br />
PFELVH&N<br />
PF1<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
CIS-PLATINUM //<br />
FLUOROURACILUM //<br />
VINBLASTINUM // ETOPOSIDUM<br />
// CALCII FOLINAS<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
P CIS-PLATINUM<br />
20 mg/m 2 /day iv (cont<strong>in</strong>uous <strong>in</strong>fusion) days<br />
1–5 //<br />
500 mg/m 2 /day iv ( cont<strong>in</strong>uous <strong>in</strong>fusion)days<br />
1–7 and days 15, 22, 29 every 28 days<br />
30 mg/m 2 iv days 1–3 // 500 mg/m 2 iv days 1–<br />
3 // 3 mg/m 2 iv day 1 // 100 mg/m 2 iv days 2<br />
and 3 // 25 mg/m 2 iv days 1–3 every 21 days<br />
25 mg/m 2 iv days 1–4 // 1000 mg/m 2 iv days<br />
1–4 every 28 days<br />
40 mg/m 2 iv day 1, every 7 days IN<br />
COMBINATION WITH RADIOTHERAPY<br />
13 963,20<br />
6 376,80<br />
7 148,40<br />
3 636,00<br />
Table 4 conta<strong>in</strong>s <strong>in</strong>formation about selected radio<strong>the</strong>rapeutic procedures, from <strong>the</strong> NHF’s<br />
catalogue <strong>of</strong> services, used <strong>in</strong> head and neck malignant neoplasms treatment, as well as its<br />
cost.<br />
Table 4.<br />
<strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected radio<strong>the</strong>rapeutic procedures used <strong>in</strong> head and neck malignant neoplasms treatment, on a basis<br />
<strong>of</strong> <strong>the</strong> NHF services catalogue<br />
Type <strong>of</strong> service<br />
Code <strong>of</strong> <strong>the</strong><br />
procedure<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure =No <strong>of</strong> po<strong>in</strong>ts<br />
x po<strong>in</strong>t price (10 PLN) [PLN]<br />
palliative teleradio<strong>the</strong>rapy 5.07.01.0000021 1 800<br />
radical teleradio<strong>the</strong>rapy with twodimensional<br />
(2D) plann<strong>in</strong>g<br />
radical teleradio<strong>the</strong>rapy with threedimensional<br />
(3D) plann<strong>in</strong>g<br />
5.07.01.0000022 5 000<br />
5.07.01.0000023 8 000<br />
standard brachy<strong>the</strong>rapy 5.07.01.0000025 4 000<br />
3D brachy<strong>the</strong>rapy with real time plann<strong>in</strong>g 5.07.01.0000026 5 200<br />
The table below conta<strong>in</strong>s selected procedures, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services,<br />
<strong>in</strong>clud<strong>in</strong>g operative treatment <strong>of</strong> head and neck malignant neoplasms metastases, as well as<br />
its cost.<br />
Table 5.<br />
Surgical procedures used <strong>in</strong> head and neck malignant neoplasms metastases treatment<br />
Name <strong>of</strong> <strong>the</strong> procedure Code <strong>of</strong> <strong>the</strong> procedure<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure<br />
=No <strong>of</strong> po<strong>in</strong>ts x po<strong>in</strong>t price<br />
(10 PLN) [PLN]<br />
excision <strong>of</strong> <strong>the</strong> maxillary neoplasm – partial 5.06.00.0000481 7 000<br />
11
and total resection <strong>of</strong> <strong>the</strong> maxilla<br />
Total or partial laryngectomy with <strong>the</strong> lymph<br />
nodes operation / with or without CO2 laser /<br />
with tracheostomy<br />
Radical or modified excision <strong>of</strong> <strong>the</strong> cervical<br />
lymphatic <strong>system</strong><br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx with cervical lymph nodes<br />
excision<br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx with cervical lymph nodes<br />
excision, mandibulotomy and/or without partial<br />
mandible resection<br />
Salivary gland neoplasm excision with cervical<br />
lymphangiectomy<br />
Mandible excision (hemiresection) with<br />
possible cervical lymphangiectomy<br />
Parotid gland neoplasm excision with <strong>the</strong> facial<br />
nerve reconstruction or with facial nerve<br />
preservation<br />
Eyelid neoplasm, exceed<strong>in</strong>g over <strong>the</strong> orbit<br />
outl<strong>in</strong>e – surgical treatment<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
5.06.00.0000682 5 200<br />
5.06.00.0000689 4 800<br />
5.06.00.0000479 7 000<br />
5.06.00.0000480 8 000<br />
5.06.00.0000482 5 000<br />
5.06.00.0000483 6 000<br />
5.06.00.0000484 4 500<br />
5.06.00.0000134 2 000<br />
Nose neoplasm excision 5.06.00.0000160 2 600<br />
Sk<strong>in</strong>/s<strong>of</strong>t tissue neoplasm excision with<br />
syn<strong>the</strong>tic implants reconstruction or with<br />
pedunculated lobes<br />
5.06.00.0000161 3 800<br />
Orbit neoplasm – surgical treatment 5.06.00.0000214 5 000<br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx<br />
2.1.4. Model parameters<br />
Ma<strong>in</strong> model parameters are shown <strong>in</strong> <strong>the</strong> table below.<br />
5.06.00.0000478 5 000<br />
12
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 6.<br />
List <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong> head and<br />
neck malignant neoplasms metastases diagnostics<br />
Parameter <strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> diagnostic procedure<br />
[PLN]<br />
<strong>Cost</strong> <strong>of</strong> surgical treatment (and/or<br />
radio<strong>the</strong>rapy) (cChir) [PLN]<br />
<strong>Cost</strong> <strong>of</strong> palliative <strong>the</strong>rapy (cPaliat)<br />
[PLN]<br />
Survival after surgical treatment<br />
(eP_Chir) [years]<br />
Survival after palliative chemo<strong>the</strong>rapy<br />
(eP_Paliat) [years]<br />
Survival after palliative chemo<strong>the</strong>rapy<br />
– wrong diagnosis (eP_Paliat2) [years]<br />
Probability <strong>of</strong> diagnostic procedure<br />
positive result (TP+FP)<br />
Probability <strong>of</strong> <strong>the</strong> correct metastases<br />
detection (pTP)<br />
4 515,00 (1 313,00*) 222,85 (174,50; 274,00)<br />
5 000,00 (2 000,00; 16 000,00)<br />
7 148,40 (3 098,40; 13 963,20)<br />
5,0 (4,0; 6,0)**<br />
1,0 (0,9; 1,1)**<br />
1,2 (1,1; 1,3)**<br />
0,3680 (0,3249; 0,4111)<br />
0,9783 (0,9568; 0,9998) 0,7391 (0,6744; 0,8039)<br />
Probability <strong>of</strong> wrong metastases<br />
detection (pFP) 0,0217 (0,0002; 0,0432) 0,2609 (0,1961; 0,3256)<br />
Probability <strong>of</strong> correct lack <strong>of</strong><br />
metastases detection (pTN)<br />
Probability <strong>of</strong> wrong lack <strong>of</strong><br />
metastases detection (pFN)<br />
0,9241 (0,8850; 0,9631) 0,7468 (0,6827; 0,8109)<br />
0,0759 (0,0369; 0,1150) 0,2532 (0,1891; 0,3173)<br />
*“threshold” <strong>PET</strong>-<strong>CT</strong> cost at 7,700 procedures per year (estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report)<br />
** on a basis <strong>of</strong> <strong>the</strong> literature and experts’ estimations<br />
• <strong>PET</strong>-<strong>CT</strong> cost amounts 4,515.00 PLN (alternative <strong>PET</strong>-<strong>CT</strong> cost, amount<strong>in</strong>g 1,313.00 PLN<br />
was also assumed – cost estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report).<br />
• The average <strong>CT</strong> cost amounts 222.85; m<strong>in</strong>imal cost <strong>of</strong> this procedure amounted 174.50<br />
PLN, maximal – 274.00 PLN.<br />
• The average cost <strong>of</strong> <strong>the</strong> head and neck malignant neoplasms treatment was<br />
assumed as equal to <strong>the</strong> cost <strong>of</strong> procedure No 5.06.00.0000482 from <strong>the</strong> catalogue <strong>of</strong><br />
hospital services (range <strong>of</strong> costs between m<strong>in</strong>imal and maximal cost <strong>of</strong> surgical<br />
procedures used <strong>in</strong> head and neck malignant neoplasms metastases treatment with<br />
consecutive radio<strong>the</strong>raphy – see table 4 and 5).<br />
• The average cost <strong>of</strong> <strong>the</strong> head and neck malignant neoplasms palliative treatment<br />
was assumed <strong>the</strong> cost <strong>of</strong> 6 cycles <strong>of</strong> PF chemo<strong>the</strong>rapy, from <strong>the</strong> catalogue <strong>of</strong><br />
oncologic services (range <strong>of</strong> costs between m<strong>in</strong>imal and maximal cost <strong>of</strong> palliative<br />
chemo<strong>the</strong>rapy used <strong>in</strong> head and neck malignant neoplasms metastases treatment –<br />
see – table 3).<br />
13
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• Life expectancy after surgical treatment, survival after palliative chemo<strong>the</strong>rapy and<br />
survival after <strong>the</strong> palliative chemo<strong>the</strong>rapy <strong>in</strong> case <strong>of</strong> wrong metastases diagnosis and<br />
its m<strong>in</strong>imal and maximal values were assumed on a basis <strong>of</strong> literature and estimation<br />
<strong>of</strong> experts from <strong>the</strong> Maria Skłodowska - Curie Memorial Institute Center <strong>of</strong> Oncology <strong>in</strong><br />
Warsaw.<br />
• Values <strong>of</strong> <strong>the</strong> parameters concern<strong>in</strong>g diagnostic tests accuracy were taken from <strong>the</strong><br />
report entitled: ”Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission<br />
tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public<br />
assets <strong>in</strong> <strong>the</strong> oncologic diagnostics - epidemiological and cl<strong>in</strong>ical part”, based on<br />
<strong>in</strong>formation from <strong>the</strong> follow<strong>in</strong>g publication:<br />
o Branstetter IV BF, Blodgett TM, Zimmer LA, Snyderman CH, Johnson JT, Raman<br />
2.1.5. Results<br />
S, Meltzer CC. Head and neck malignancy: Is <strong>PET</strong>-<strong>CT</strong> more accurate than <strong>PET</strong><br />
or <strong>CT</strong> alone?. Radiology 2005; Vol. 235 (2): pp 580–586.<br />
The follow<strong>in</strong>g table conta<strong>in</strong>s results <strong>of</strong> <strong>the</strong> comparative cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong><br />
<strong>PET</strong>-<strong>CT</strong> vs head computed tomography <strong>in</strong> <strong>the</strong> head and neck malignant neoplasms<br />
metastases diagnostics, where average survival <strong>of</strong> patients (<strong>in</strong> years) is considered as <strong>effect</strong>.<br />
Cohort simulation method was used <strong>in</strong> calculations.<br />
Table 7.<br />
List <strong>of</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> results <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm metastases<br />
diagnostics<br />
Procedure<br />
<strong>Cost</strong> per one<br />
patient [PLN]<br />
<strong>Cost</strong> difference<br />
[PLN]<br />
Average<br />
survival [years]<br />
<strong>PET</strong>-<strong>CT</strong> 10 648,51 3,338<br />
<strong>CT</strong> 7 157,37<br />
3 491,14<br />
2,907<br />
Effects<br />
difference<br />
(LYG)<br />
ICER<br />
[PLN/LYG]<br />
0,431 8 100,09<br />
The <strong>analysis</strong> revealed that head and neck malignant neoplasms diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is<br />
more expensive than us<strong>in</strong>g computed tomography, but simultaneously gives better long-term<br />
<strong>effect</strong>, measured with <strong>the</strong> quantity <strong>of</strong> life years ga<strong>in</strong>ed. Total <strong>PET</strong>-<strong>CT</strong> cost <strong>in</strong>cluded costs <strong>of</strong> <strong>the</strong><br />
diagnostic procedure, metastases surgical treatment and costs <strong>of</strong> palliative chemo<strong>the</strong>rapy.<br />
<strong>Cost</strong>s difference between diagnostic procedures amounts 3,491.14 PLN per one patient.<br />
Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong> one patient, may result <strong>in</strong> ga<strong>in</strong><strong>in</strong>g <strong>the</strong> <strong>effect</strong> <strong>of</strong> 3.338 life years. In a group <strong>of</strong><br />
patients diagnosed with computed tomography, <strong>the</strong> predicted <strong>effect</strong> amounts 2.907 life<br />
14
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
years. Effects difference between us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> amounts 0.431 LYG (life years ga<strong>in</strong>ed),<br />
i.e. approx. 157 days.<br />
Head and neck malignant neoplasms diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more expensive and<br />
simultaneously more <strong>effect</strong>ive than us<strong>in</strong>g computed tomography. Incremental cost-<br />
<strong>effect</strong>iveness ratio (ICER) amounts 8,100.09 PLN/LYG that means, ga<strong>in</strong><strong>in</strong>g one additional life<br />
year us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong>stead <strong>of</strong> <strong>CT</strong> costs 8,100.09 PLN.<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> was also performed us<strong>in</strong>g Monte Carlo simulation method for<br />
100,000 patients. Results are shown <strong>in</strong> table 8.<br />
Table 8.<br />
Results <strong>of</strong> <strong>analysis</strong> obta<strong>in</strong>ed us<strong>in</strong>g <strong>the</strong> Monte Carlo simulation method for 100,000 patients, compar<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
<strong>in</strong> <strong>the</strong> head and neck malignant neoplasm metastases diagnostics<br />
Parameter<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> (PLN) Effect [years] <strong>Cost</strong> (PLN) Effect [years]<br />
ICER<br />
[PLN/LYG]<br />
Mean 10 645,57 3,344 7 160,97 2,909 8 010,57<br />
Standard deviation 1 693,56 1,969 2 482,48 1,980<br />
M<strong>in</strong>imal value 9 515,00 1,000 5 222,85 1,000<br />
Median 9 515,00 5,000 7 371,25 1,200<br />
M<strong>in</strong>imal value 16 663,40 5,000 12 371,25 5,000<br />
Results obta<strong>in</strong>ed us<strong>in</strong>g Monte Carlo method do not differ form results obta<strong>in</strong>ed <strong>in</strong> <strong>the</strong> cohort<br />
simulation method. <strong>PET</strong>-<strong>CT</strong> diagnostics rema<strong>in</strong>s more expensive procedure and more<br />
<strong>effect</strong>ive than us<strong>in</strong>g computed tomography only. The difference <strong>of</strong> average <strong>effect</strong> amounts<br />
0.435 life year. Effect median, <strong>in</strong> a group <strong>of</strong> patients diagnosed us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> amounts 5 years,<br />
and <strong>in</strong> <strong>the</strong> <strong>CT</strong> group – 1.2 year. Incremental cost-<strong>effect</strong>iveness ratio (ICER) amounts 8,010.57<br />
PLN/LYG that means, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong>stead <strong>of</strong> <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasms<br />
metastases detection costs 8,010.57 PLN.<br />
2.1.6. Sensitivity <strong>analysis</strong><br />
One-way sensitivity <strong>analysis</strong> for <strong>the</strong> comparison <strong>of</strong> head and neck metastases detection<br />
us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> vs computed tomography was performed for different model parameters:<br />
-<br />
15
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• assumption <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> cost amount<strong>in</strong>g 1,313.00 PLN (“subthreshold” <strong>PET</strong>-<strong>CT</strong> cost at<br />
7,700 procedures per year, estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong><br />
<strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report);<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>CT</strong>;<br />
• assumption <strong>of</strong> alternative <strong>CT</strong> cost amount<strong>in</strong>g 335.55 PLN – one or more parts <strong>of</strong> <strong>the</strong><br />
body exam<strong>in</strong>ation;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> surgical treatment;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> palliative treatment;<br />
• m<strong>in</strong>imal and maximal life expectancy after surgical treatment;<br />
• m<strong>in</strong>imal and maximal life expectancy after palliative chemo<strong>the</strong>rapy;<br />
• m<strong>in</strong>imal and maximal life expectancy after palliative chemo<strong>the</strong>rapy, <strong>in</strong> case <strong>of</strong> wrong<br />
metastases diagnosis;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> ga<strong>in</strong><strong>in</strong>g positive result <strong>in</strong> <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong>;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> correct and <strong>in</strong>correct metastases detection;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> correct and <strong>in</strong>correct lack <strong>of</strong> metastases<br />
detection;<br />
Sensitivity <strong>analysis</strong> results for variable model parameters are shown <strong>in</strong> <strong>the</strong> table below.<br />
Table 9.<br />
Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm metastases diagnostics<br />
Parameter<br />
<strong>Cost</strong> (PLN)<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
Effect<br />
[years]<br />
<strong>Cost</strong> (PLN)<br />
Effect<br />
[years]<br />
ICER [PLN/LYG]<br />
Basel<strong>in</strong>e state 10 648,51 3,338 7 157,37 2,907 8 100,09<br />
Alternative <strong>PET</strong>-<strong>CT</strong> cost 7 446,51 3,338 7 157,37 2,907 670,86<br />
M<strong>in</strong>imal <strong>CT</strong> cost 10 648,51 3,338 7 109,02 2,907 8 212,27<br />
Maximal <strong>CT</strong> cost 10 648,51 3,338 7 208,52 2,907 7 9818,41<br />
Alternative <strong>CT</strong> cost 10 648,51 3,338 7 270,07 2,907 7 838,61<br />
M<strong>in</strong>imal cost <strong>of</strong> surgical<br />
treatment<br />
Maximal cost <strong>of</strong> surgical<br />
treatment<br />
8 752,51 3,338 5 261,37 2,907 8 100,09<br />
17 600,51 3,338 14 109,37 2,907 8 100,09<br />
M<strong>in</strong>imal cost <strong>of</strong> palliative 8 963,84 3,338 5 018,87 2,907 9 153,06<br />
16
<strong>the</strong>rapy<br />
Maximal cost <strong>of</strong> palliative<br />
<strong>the</strong>rapy<br />
M<strong>in</strong>imal survival after surgical<br />
treatment<br />
Maximal survival after surgical<br />
treatment<br />
M<strong>in</strong>imal survival after palliative<br />
chemo<strong>the</strong>rapy<br />
Maximal survival after palliative<br />
chemo<strong>the</strong>rapy<br />
M<strong>in</strong>imal survival after palliative<br />
chemo<strong>the</strong>rapy – wrong<br />
diagnosis<br />
Maximal survival after palliative<br />
chemo<strong>the</strong>rapy – wrong<br />
diagnosis<br />
M<strong>in</strong>imal probability <strong>of</strong> ga<strong>in</strong><strong>in</strong>g a<br />
positive result <strong>in</strong> <strong>PET</strong>-<strong>CT</strong><br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
13 483,26 3,338 10 755,73 2,907 6 328,38<br />
10 648,51 2,754 7 157,37 2,435 10 959,30<br />
10 648,51 3,922 7 157,37 3,379 6 433,36<br />
10 648,51 3,297 7 157,37 2,864 8 062,68<br />
10 648,51 3,379 7 157,37 2,950 8 137,86<br />
10 648,51 3,337 7 157,37 2,898 7 952,48<br />
10 648,51 3,339 7 157,37 2,917 8 272,84<br />
10 579,46 3,496 7 157,37 2,907 5 810,00<br />
Maximal probability <strong>of</strong> ga<strong>in</strong><strong>in</strong>g a<br />
positive result <strong>in</strong> <strong>PET</strong>-<strong>CT</strong> 10 717,56 3,179 7 157,37 2,907 13 088,93<br />
M<strong>in</strong>imal probability <strong>of</strong> ga<strong>in</strong><strong>in</strong>g a<br />
positive result <strong>in</strong> <strong>CT</strong><br />
Maximal probability <strong>of</strong> ga<strong>in</strong><strong>in</strong>g a<br />
positive result <strong>in</strong> <strong>CT</strong><br />
M<strong>in</strong>imal probability <strong>of</strong> correct<br />
metastases detection<br />
Maximal probability <strong>of</strong> correct<br />
metastases detection<br />
Maximal probability <strong>of</strong> <strong>in</strong>correct<br />
metastases detection<br />
M<strong>in</strong>imal probability <strong>of</strong> correct<br />
lack <strong>of</strong> metastases detection<br />
Maximal probability <strong>of</strong> correct<br />
lack <strong>of</strong> metastases detection<br />
Maximal probability <strong>of</strong> <strong>in</strong>correct<br />
lack <strong>of</strong> metastases detection<br />
10 648,51 3,338 7 142,81 3,033 11 494,10<br />
10 648,51 3,338 7 171,92 2,781 6 241,63<br />
10 648,51 3,339 7 157,37 2,912 8 167,78<br />
10 648,51 3,336 7 157,37 2,902 8 047,88<br />
10 648,51 3,339 7 157,37 2,912 8 167,78<br />
10 825,16 3,239 7 446,96 2,745 6 841,11<br />
10 472,32 3,436 6 867,78 3,069 9 817,44<br />
10 825,16 3,239 7 446,96 2,745 6 841,11<br />
Generally, <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>the</strong>re were not any abrupt changes <strong>of</strong> costs and <strong>effect</strong>s<br />
for <strong>the</strong> described parameters, characteriz<strong>in</strong>g compared diagnostic schemes. Head and neck<br />
malignant neoplasm diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> rema<strong>in</strong>s more expensive and more <strong>effect</strong>ive<br />
than <strong>CT</strong>. The m<strong>in</strong>imal ICAR value was observed <strong>in</strong> case <strong>of</strong> assumption <strong>the</strong> alternative cost <strong>of</strong><br />
17
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
<strong>PET</strong>-<strong>CT</strong> procedure on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN (decrease <strong>of</strong> 91.71%). Maximal ICER value was<br />
observed <strong>in</strong> case <strong>of</strong> assumption <strong>the</strong> maximal probability <strong>of</strong> obta<strong>in</strong><strong>in</strong>g a positive result <strong>in</strong> <strong>PET</strong>-<strong>CT</strong><br />
exam<strong>in</strong>ation (ICER <strong>in</strong>crease <strong>of</strong> 61.58% from <strong>the</strong> basel<strong>in</strong>e value).<br />
2.2. RECURRENCES DIAGNOSTICS<br />
2.2.1. Model description<br />
Model used <strong>in</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> concerns a group <strong>of</strong> patients with head and<br />
neck malignant neoplasms undergo<strong>in</strong>g follow-up diagnostics after treatment, aim<strong>in</strong>g to<br />
detect <strong>the</strong> possible disease recurrence. Effects and costs <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> diagnostics were<br />
compared. In <strong>the</strong> <strong>analysis</strong>, a decision model (TreeAge® 2004 s<strong>of</strong>tware – version 7) was used.<br />
Time until death <strong>of</strong> patient was assumed as a time horizon, cost data were estimated from<br />
<strong>the</strong> public payer’s perspective, on a basis <strong>of</strong> available data. The <strong>effect</strong>iveness <strong>of</strong> compared<br />
diagnostic procedures was assessed <strong>in</strong> a cl<strong>in</strong>ical par <strong>of</strong> “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong><br />
<strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland<br />
from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics - epidemiological and cl<strong>in</strong>ical part”<br />
report. Data concern<strong>in</strong>g treatment <strong>effect</strong>s and consequences <strong>of</strong> <strong>in</strong>correct treatment<br />
result<strong>in</strong>g from <strong>the</strong> <strong>in</strong>correct diagnosis was presented on a basis <strong>of</strong> literature or experts'<br />
estimation, <strong>in</strong> case <strong>of</strong> unavailability <strong>of</strong> <strong>the</strong> data.<br />
Information concern<strong>in</strong>g <strong>the</strong> ability <strong>of</strong> <strong>the</strong> test to correct patient assessment and data<br />
concern<strong>in</strong>g errors <strong>in</strong> diagnostics were used <strong>in</strong> <strong>the</strong> model. Incorrect diagnostics may result <strong>in</strong><br />
health and f<strong>in</strong>ancial losses.<br />
2.2.2. Model transient states<br />
Decision model <strong>in</strong>cludes <strong>the</strong> follow<strong>in</strong>g transient states (same for both variants <strong>of</strong> diagnostic<br />
procedure):<br />
• „Head and neck neoplasms” basal state, characteriz<strong>in</strong>g patients population at <strong>the</strong><br />
beg<strong>in</strong>n<strong>in</strong>g <strong>of</strong> treatment. After diagnostic procedure patient may pass to <strong>the</strong> follow<strong>in</strong>g<br />
states:<br />
o Diagnosis: recurrence (if <strong>the</strong> diagnostic procedure revealed head and neck<br />
malignant neoplasm recurrence);<br />
18
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
o Diagnosis: no recurrence (if <strong>the</strong>re is no recurrence <strong>of</strong> head and neck<br />
malignant neoplasm).<br />
• “Diagnosis: recurrence” – <strong>in</strong>cludes patients diagnosed with head and neck malignant<br />
neoplasms recurrence. After recurrence detection, patients may pass to <strong>the</strong> follow<strong>in</strong>g<br />
f<strong>in</strong>al states:<br />
o Patient with recurrence (<strong>in</strong> case <strong>of</strong> correct recurrence detection);<br />
o Patient without recurrence (<strong>in</strong> case <strong>of</strong> <strong>in</strong>correct recurrence detection).<br />
• “Diagnosis: no recurrence” – <strong>in</strong>cludes patients diagnosed without head and neck<br />
malignant neoplasms recurrence detection. if <strong>the</strong> recurrence is not detected, patient<br />
may pass to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Patient with recurrence (<strong>in</strong> case <strong>of</strong> <strong>in</strong>correct lack <strong>of</strong> recurrence detection);<br />
o Patient without recurrence (<strong>in</strong> case <strong>of</strong> correct lack <strong>of</strong> recurrence detection).<br />
The follow<strong>in</strong>g figure shows an illustration <strong>of</strong> <strong>the</strong> decision model, describ<strong>in</strong>g <strong>the</strong> course <strong>of</strong><br />
head and neck malignant neoplasms recurrences detection <strong>in</strong> patient diagnosed us<strong>in</strong>g <strong>PET</strong>-<br />
<strong>CT</strong> or computed tomography.<br />
Figure 2.<br />
Decision tree present<strong>in</strong>g model used <strong>in</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison, <strong>in</strong> <strong>the</strong> head and neck malignant<br />
neoplasms recurrences detection (legend - table 15)<br />
As presented <strong>in</strong> <strong>the</strong> figure 2, it is assumed that all patients with positive result <strong>of</strong> diagnostic<br />
tests had palliative chemo<strong>the</strong>rapy treatment, patients with negative result had no treatment.<br />
19
2.2.3 <strong>Cost</strong>s calculation<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
In <strong>the</strong> studies concern<strong>in</strong>g head and neck malignant neoplasms, <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> method was<br />
compared to <strong>the</strong> computed tomography with contrast media (<strong>CT</strong>). Computed tomography<br />
(<strong>CT</strong>) <strong>of</strong> <strong>the</strong> head is an out-patient, co-f<strong>in</strong>anced (ASDW) diagnostic service, that amounts 28<br />
po<strong>in</strong>ts – 23 po<strong>in</strong>ts are refunded by <strong>the</strong> National Health Fund and <strong>the</strong> 5 rema<strong>in</strong><strong>in</strong>g po<strong>in</strong>ts are<br />
covered by a physician referr<strong>in</strong>g to <strong>the</strong> procedure (“Catalogue <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced out-<br />
patient diagnostic procedures ranges (ASDW)”. Annex No. 1b to <strong>the</strong> <strong>in</strong>formational materials<br />
AOS). Referrer covers <strong>the</strong> cost <strong>of</strong> performed procedure, accord<strong>in</strong>g to <strong>the</strong> negotiated price <strong>of</strong><br />
<strong>the</strong> po<strong>in</strong>t. The National Health Fund covers <strong>the</strong> cost <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced diagnostic procedure,<br />
accord<strong>in</strong>gly to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by: health care provider perform<strong>in</strong>g <strong>the</strong><br />
procedure and by <strong>the</strong> referrer.<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on<br />
<strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories hav<strong>in</strong>g <strong>the</strong> contract<br />
with <strong>the</strong> National Health Fund <strong>in</strong> Poland, amounts 8.05 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> service from <strong>the</strong> ASDW catalogue,<br />
toge<strong>the</strong>r with its cost calculation.<br />
Table 10.<br />
Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
with contrast media<br />
Name and code <strong>of</strong><br />
<strong>the</strong> procedure<br />
<strong>CT</strong>: Head <strong>CT</strong> with <strong>the</strong><br />
contrast media<br />
5.03.00.0000025<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
<strong>CT</strong> laboratory Oncologic<br />
dispensary<br />
Test<br />
cost<br />
(PLN)<br />
23 5 8,05 7,54 222,85<br />
<strong>PET</strong>-<strong>CT</strong> is an <strong>in</strong>dividually contracted service, amount<strong>in</strong>g 420 po<strong>in</strong>ts. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz, <strong>the</strong><br />
sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
20
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Table 11.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
420 10,75<br />
Test cost [PLN]<br />
4 515,00<br />
The average <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> head and neck malignant<br />
neoplasm amounts 222.85 PLN, and <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong> public payer’s<br />
perspective – amounts 4,515.00 PLN.<br />
The follow<strong>in</strong>g table shows selected items, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services, used to<br />
calculate <strong>the</strong> costs <strong>of</strong> 6 cycles <strong>of</strong> chemo<strong>the</strong>rapy or 6 months <strong>of</strong> palliative chemo<strong>the</strong>rapy.<br />
Table 12.<br />
<strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies, from <strong>the</strong> NHF services catalogue, used <strong>in</strong> head and neck malignant neoplasms<br />
treatment<br />
Type <strong>of</strong> <strong>the</strong><br />
<strong>the</strong>rapy<br />
PF<br />
Active substances Posology<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
100 mg/m 2 iv day 1 // 800–1000 mg/m 2 iv<br />
days 1–4 (CONTINUOUS INFUSION 96 H WITH<br />
OR WITHOUT COMBINATION WITH<br />
RADIOTHERAPY)<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong><br />
procedure =No<br />
<strong>of</strong> po<strong>in</strong>ts x po<strong>in</strong>t<br />
price (10 PLN)<br />
[PLN]<br />
7 148,40<br />
MTX METHOTREXATUM 40 mg/m 2 day 1 every 7 days 3 098,40<br />
PFH&N<br />
PFELVH&N<br />
PF1<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
CIS-PLATINUM //<br />
FLUOROURACILUM //<br />
VINBLASTINUM // ETOPOSIDUM<br />
// CALCII FOLINAS<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
P CIS-PLATINUM<br />
20 mg/m 2 /day iv (cont<strong>in</strong>uous <strong>in</strong>fusion) days<br />
1–5 // 500 mg/m 2 /day iv (cont<strong>in</strong>uous <strong>in</strong>fusion)<br />
days 1-7 and days 15, 22, 29 every 28 days<br />
30 mg/m 2 iv days 1–3 // 500 mg/m 2 iv days 1–<br />
3 // 3 mg/m 2 iv day 1 // 100 mg/m 2 iv days 2<br />
and 3 // 25 mg/m 2 iv days 1–3 every 21 days<br />
25 mg/m 2 iv days 1–4 // 1000 mg/m 2 iv days 1–<br />
4 every 28 days<br />
40 mg/m 2 iv day 1 every 7 days IN<br />
COMBINATION WITH RADIOTHERAPY<br />
13 963,20<br />
6 376,80<br />
7 148,40<br />
3 636,00<br />
21
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 13. conta<strong>in</strong>s selected radio<strong>the</strong>rapeutic procedures from <strong>the</strong> NHF’s catalogue <strong>of</strong><br />
services, used <strong>in</strong> head and neck malignant neoplasms treatment and its cost.<br />
Table 13.<br />
<strong>Cost</strong>s <strong>of</strong> selected radio<strong>the</strong>rapeutic procedures used <strong>in</strong> head and neck malignant neoplasms treatment, on a basis <strong>of</strong><br />
NHF's catalogue <strong>of</strong> services.<br />
Type <strong>of</strong> service<br />
Code <strong>of</strong> <strong>the</strong><br />
procedure<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure =No <strong>of</strong> po<strong>in</strong>ts<br />
x po<strong>in</strong>t price (10 PLN) [PLN]<br />
palliative teleradio<strong>the</strong>rapy 5.07.01.0000021 1 800<br />
radical teleradio<strong>the</strong>rapy with twodimensional<br />
(2D) plann<strong>in</strong>g<br />
radical teleradio<strong>the</strong>rapy with threedimensional<br />
(3D) plann<strong>in</strong>g<br />
5.07.01.0000022 5 000<br />
5.07.01.0000023 8 000<br />
standard brachy<strong>the</strong>rapy 5.07.01.0000025 4 000<br />
3D brachy<strong>the</strong>rapy with real time plann<strong>in</strong>g 5.07.01.0000026 5 200<br />
The table below conta<strong>in</strong>s selected procedures, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services as well<br />
as cost <strong>of</strong> operative treatment <strong>of</strong> head and neck malignant neoplasms recurrences.<br />
Table 14.<br />
Surgical procedures used <strong>in</strong> head and neck malignant neoplasms treatment<br />
Name <strong>of</strong> <strong>the</strong> procedure Code <strong>of</strong> <strong>the</strong> procedure<br />
excision <strong>of</strong> <strong>the</strong> maxillary neoplasm – partial<br />
and total resection <strong>of</strong> <strong>the</strong> maxilla<br />
Total or partial laryngectomy with <strong>the</strong> lymph<br />
nodes operation / with or without CO2 laser /<br />
with tracheostomy<br />
Radical or modified excision <strong>of</strong> <strong>the</strong> cervical<br />
lymphatic <strong>system</strong><br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx with cervical lymph nodes<br />
excision<br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx with cervical lymph nodes<br />
excision, mandibulotomy and/or without partial<br />
mandible resection<br />
Salivary gland neoplasm excision with cervical<br />
lymphangiectomy<br />
Mandible excision (hemiresection) with<br />
possible cervical lymphangiectomy<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure<br />
=No <strong>of</strong> po<strong>in</strong>ts x po<strong>in</strong>t price<br />
(10 PLN) [PLN]<br />
5.06.00.0000481 7 000<br />
5.06.00.0000682 5 200<br />
5.06.00.0000689 4 800<br />
5.06.00.0000479 7 000<br />
5.06.00.0000480 8 000<br />
5.06.00.0000482 5 000<br />
5.06.00.0000483 6 000<br />
22
Parotid gland neoplasm excision with <strong>the</strong> facial<br />
nerve reconstruction or with facial nerve<br />
preservation<br />
Eyelid neoplasm, exceed<strong>in</strong>g over <strong>the</strong> orbit<br />
outl<strong>in</strong>e – surgical treatment<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
5.06.00.0000484 4 500<br />
5.06.00.0000134 2 000<br />
Nose neoplasm excision 5.06.00.0000160 2 600<br />
Sk<strong>in</strong>/s<strong>of</strong>t tissue neoplasm excision with<br />
syn<strong>the</strong>tic implants reconstruction or with<br />
pedunculated lobes<br />
5.06.00.0000161 3 800<br />
Orbit neoplasm – surgical treatment 5.06.00.0000214 5 000<br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx<br />
2.2.4 Model parameters<br />
Ma<strong>in</strong> model parameters are presented <strong>in</strong> <strong>the</strong> table below.<br />
5.06.00.0000478 5 000<br />
Table 15.<br />
List <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong> head and<br />
neck malignant neoplasms recurrences diagnostics<br />
Parameter <strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> diagnostic procedure<br />
[PLN]<br />
<strong>Cost</strong> <strong>of</strong> palliative <strong>the</strong>rapy (cPaliat)<br />
[PLN]<br />
Survival <strong>in</strong> case <strong>of</strong> no recurrence<br />
(eP_Brak Nawrotu) [years]<br />
Survival after palliative chemo<strong>the</strong>rapy<br />
(eP_Paliat) [years]<br />
Survival after no treatment (delayed<br />
palliative chemo<strong>the</strong>rapy) – wrong<br />
diagnosis (eP_Paliat2) [years]<br />
Probability <strong>of</strong> diagnostic procedure<br />
positive result (TP+FP)<br />
Probability <strong>of</strong> correct recurrence<br />
detection (pTP)<br />
Probability <strong>of</strong> <strong>in</strong>correct recurrence<br />
detection (pFP)<br />
Probability <strong>of</strong> correct lack <strong>of</strong><br />
recurrence detection (pTN)<br />
4 515,00 (1 313,00*) 222,85 (174,50; 274,00)<br />
7 148,40 (3 098,40; 13 963,20)<br />
5,0 (4,0; 6,0)<br />
1,0 (0,9; 1,1)<br />
0,7 (0,6; 0,8)<br />
0,3680 (0,3249; 0,4111)<br />
0,9783 (0,9568; 0,9998) 0,7391 (0,6744; 0,8039)<br />
0,0217 (0,0002; 0,0432) 0,2609 (0,1961; 0,3256)<br />
0,9241 (0,8850; 0,9631) 0,7468 (0,6827; 0,8109)<br />
Probability <strong>of</strong> wrong lack <strong>of</strong> 0,0759 (0,0369; 0,1150) 0,2532 (0,1891; 0,3173)<br />
23
ecurrence detection (pFN)<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
*“threshold” <strong>PET</strong>-<strong>CT</strong> cost at 7,700 procedures per year (estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report)<br />
• <strong>PET</strong>-<strong>CT</strong> cost amounts 4,515.00 PLN (alternative <strong>PET</strong>-<strong>CT</strong> cost, amount<strong>in</strong>g 1,313.00 PLN<br />
was also assumed – cost estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report).<br />
• The average <strong>CT</strong> cost amounts 222.85; m<strong>in</strong>imal cost <strong>of</strong> this procedure amounted 174.50<br />
PLN, maximal – 274.00 PLN.<br />
• Cos <strong>of</strong> 6 cycles <strong>of</strong> PF chemo<strong>the</strong>rapy (form <strong>the</strong> oncologic procedures catalogue) was<br />
assumed as an average cost <strong>of</strong> palliative treatment, <strong>in</strong> case <strong>of</strong> head and neck<br />
malignant neoplasms (<strong>the</strong> costs range between m<strong>in</strong>imal and maximal cost <strong>of</strong><br />
palliative chemo<strong>the</strong>rapy, used <strong>in</strong> head and neck malignant tumors treatment – see<br />
table 12).<br />
• Life expectancy, after palliative chemo<strong>the</strong>rapy without recurrence and life<br />
expectancy after <strong>the</strong> delayed palliative chemo<strong>the</strong>rapy, due to <strong>the</strong> wrong diagnosis,<br />
as well as its m<strong>in</strong>imal and maximal valued are presented, on a basis <strong>of</strong> literature or<br />
experts’ from <strong>the</strong> Maria Skłodowska – Curie Memorial Institute <strong>in</strong> Warsaw.<br />
• Values <strong>of</strong> <strong>the</strong> rest <strong>of</strong> parameters were taken from <strong>the</strong> report: “Comparative cost –<br />
<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic<br />
technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics -<br />
epidemiological and cl<strong>in</strong>ical part”. Information from <strong>the</strong> follow<strong>in</strong>g publications were<br />
used:<br />
o Branstetter IV BF, Blodgett TM, Zimmer LA, Snyderman CH, Johnson JT, Raman<br />
2.2.5. Results<br />
S, Meltzer CC. Head and neck malignancy: Is <strong>PET</strong>-<strong>CT</strong> more accurate than <strong>PET</strong><br />
or <strong>CT</strong> alone?. Radiology 2005; Vol. 235 (2): pp 580–586.<br />
The follow<strong>in</strong>g table shows results <strong>of</strong> <strong>the</strong> comparative cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs<br />
computed tomography used <strong>in</strong> head and neck malignant neoplasms recurrence<br />
diagnostics, where <strong>the</strong> average life expectancy expressed <strong>in</strong> years, was considered as <strong>the</strong><br />
<strong>effect</strong>. Cohort simulation method was used <strong>in</strong> calculations.<br />
24
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 16.<br />
Results <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm recurrence<br />
diagnostics<br />
Procedure<br />
<strong>Cost</strong> per one<br />
patient [PLN]<br />
<strong>Cost</strong> difference<br />
[PLN]<br />
Average life<br />
expectancy<br />
[years]<br />
<strong>PET</strong>-<strong>CT</strong> 7 145,61 3,354<br />
<strong>CT</strong> 2 853,46<br />
4 292,15<br />
3,224<br />
Effects<br />
difference<br />
(LYG)<br />
ICER<br />
[PLN/LYG]<br />
0,130 33 016,54<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> revealed, that head and neck malignant neoplasms diagnostics<br />
us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more expensive than us<strong>in</strong>g computed tomography, but simultaneously gives a<br />
better long-term <strong>effect</strong>, measured with life years ga<strong>in</strong>ed ratio. Total <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> cost<br />
<strong>in</strong>cluded costs <strong>of</strong> <strong>the</strong> diagnostic procedure, surgical treatment and costs <strong>of</strong> palliative<br />
chemo<strong>the</strong>rapy. The cost difference between diagnostic procedures amounts 4,292.15 PLN<br />
per one patient. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong> one patient allows to ga<strong>in</strong> 3.354 life years. In a group <strong>of</strong><br />
patients, where computed tomography is performed, <strong>the</strong> anticipated <strong>effect</strong> amounts 3.224<br />
life years. Difference <strong>of</strong> <strong>effect</strong>s between <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> amounts 0.130 LYG (life years ga<strong>in</strong>ed)<br />
i.e. approx. 48 days.<br />
Head and neck malignant neoplasms recurrence diagnostics, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>system</strong> is more<br />
expensive, but more <strong>effect</strong>ive than computed tomography diagnostics. Incremental cost-<br />
<strong>effect</strong>iveness ratio amounts 33,016.54 PLN/LYG, that means, ga<strong>in</strong><strong>in</strong>g one additional year <strong>of</strong><br />
life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, costs 33,016.54 PLN.<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> was also performed us<strong>in</strong>g Monte Carlo simulation method for<br />
100,000 patients. Results are shown <strong>in</strong> table 17.<br />
25
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 17.<br />
Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck<br />
malignant neoplasm recurrence diagnostics<br />
Parameter<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> [PLN] Effect [years] <strong>Cost</strong> [PLN] Effect [years]<br />
ICER<br />
[PLN/LYG]<br />
Average 7 143,07 3,353 2 850,92 3,225 33 532,42<br />
Standard deviation 3 446,70 1,984 3 446,70 2,039<br />
M<strong>in</strong>imal value 4 515,00 0,700 222,85 0,700<br />
Median 4 515,00 5,000 222,85 5,000<br />
Maximal value 11 663,40 5,000 7 371,25 5,000<br />
Results obta<strong>in</strong>ed us<strong>in</strong>g <strong>the</strong> Monte Carlo method do not differ from results obta<strong>in</strong>ed <strong>in</strong> <strong>the</strong><br />
cohort simulation method. <strong>PET</strong>-<strong>CT</strong> diagnostics method rema<strong>in</strong>s more expensive and more<br />
<strong>effect</strong>ive than us<strong>in</strong>g computed tomography only. Difference <strong>of</strong> <strong>effect</strong>s averages amounts<br />
0.128 <strong>of</strong> a life year. Median <strong>of</strong> <strong>the</strong> <strong>effect</strong> <strong>in</strong> a group <strong>of</strong> patients diagnosed us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> and<br />
<strong>CT</strong> amount 5 life years. Incremental cost-<strong>effect</strong>iveness ratio amounts 33,532.42 PLN/LYG, that<br />
means, ga<strong>in</strong><strong>in</strong>g one additional year <strong>of</strong> life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> head and neck<br />
malignant neoplasms recurrence detection, <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, costs 33,532.42 PLN.<br />
2.2.6. Sensitivity <strong>analysis</strong><br />
One-way sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> diagnostics <strong>in</strong> head and neck malignant<br />
neoplasms recurrence detection was performed for <strong>the</strong> different model parameters;<br />
• assumption <strong>the</strong> alternative <strong>PET</strong>-<strong>CT</strong> cost on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN (“threshold” <strong>PET</strong>-<strong>CT</strong><br />
cost at 7,700 procedures per year, estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong><br />
diagnostics <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report);<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> <strong>CT</strong>;<br />
• assumption <strong>of</strong> <strong>the</strong> alternative cost <strong>of</strong> <strong>the</strong> <strong>CT</strong>, amount<strong>in</strong>g 335.55 PLN – one or more<br />
parts <strong>of</strong> <strong>the</strong> body exam<strong>in</strong>ation;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> palliative treatment;<br />
• m<strong>in</strong>imal and maximal life expectancy, <strong>in</strong> case <strong>of</strong> lack <strong>of</strong> recurrence;<br />
• m<strong>in</strong>imal and maximal life expectancy after palliative chemo<strong>the</strong>rapy;<br />
-<br />
26
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• m<strong>in</strong>imal and maximal life expectancy <strong>in</strong> case <strong>of</strong> no treatment (delayed palliative<br />
chemo<strong>the</strong>rapy) <strong>in</strong> case <strong>of</strong> wrong diagnosis;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> ga<strong>in</strong><strong>in</strong>g a positive result <strong>in</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong>;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> <strong>the</strong> correct recurrence diagnosis;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> <strong>the</strong> correct diagnosis <strong>of</strong> no recurrence;<br />
• maximal probabilities <strong>of</strong> <strong>the</strong> wrong detection <strong>of</strong> recurrence and wrong detection <strong>of</strong><br />
no recurrence.<br />
Sensitivity <strong>analysis</strong> results for <strong>the</strong> variable model parameters are shown <strong>in</strong> table below.<br />
Table 18.<br />
Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm recurrences diagnostics<br />
Parameter<br />
<strong>Cost</strong> [PLN]<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
Effect<br />
[years]<br />
<strong>Cost</strong> [PLN]<br />
Effect<br />
[years]<br />
ICER [PLN/LYG]<br />
Basel<strong>in</strong>e state 7 145,61 3,354 2 853,46 3,224 33 016,54<br />
Alternative <strong>PET</strong>-<strong>CT</strong> cost 3 943,61 3,354 2 853,46 3,224 8 385,77<br />
M<strong>in</strong>imal cost <strong>of</strong> <strong>CT</strong> 7 145,61 3,354 2 805,11 3,224 33 388,46<br />
Maximal cost <strong>of</strong> <strong>CT</strong> 7 145,61 3,354 2 904,61 3,224 32 623,08<br />
Alternative cost <strong>of</strong> <strong>CT</strong> 7 145,61 3,354 2 966,16 3,224 32 149,62<br />
M<strong>in</strong>imal cost <strong>of</strong> palliative<br />
chemo<strong>the</strong>rapy<br />
Maximal cost <strong>of</strong> palliative<br />
chemo<strong>the</strong>rapy<br />
M<strong>in</strong>imal survival <strong>in</strong> case <strong>of</strong> no<br />
recurrence<br />
Maximal survival <strong>in</strong> case <strong>of</strong> no<br />
recurrence<br />
5 655,21 3,354 1 363,06 3,224 33 016,54<br />
9 653,46 3,354 5 361,31 3,224 33 016,54<br />
7 145,61 2,762 2 853,46 2,656 40 491,98<br />
7 145,61 3,946 2 853,46 3,792 27 871,10<br />
M<strong>in</strong>imal survival after <strong>the</strong><br />
palliative chemo<strong>the</strong>rapy 7 145,61 3,318 2 853,46 3,197 35 472,31<br />
Maximal survival after <strong>the</strong><br />
palliative chemo<strong>the</strong>rapy<br />
M<strong>in</strong>imal survival after no<br />
treatment (delayed palliative<br />
chemo<strong>the</strong>rapy) – wrong<br />
diagnosis<br />
Maximal survival after no<br />
treatment (delayed palliative<br />
chemo<strong>the</strong>rapy) – wrong<br />
7 145,61 3,390 2 853,46 3,251 30 878,78<br />
7 145,61 3,349 2 853,46 3,208 30 440,78<br />
7 145,61 3,358 2 853,46 3,240 36 374,15<br />
27
diagnosis<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
diagnostic procedure positive<br />
result<br />
Maximal probability <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
diagnostic procedure positive<br />
result<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>CT</strong><br />
diagnostic procedure positive<br />
result<br />
Maximal probability <strong>of</strong> <strong>CT</strong><br />
diagnostic procedure positive<br />
result<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
6 838,23 3,508 2 853,46 3,224 14 030,88<br />
7 452,99 3,199 2 853,46 3,224<br />
Dom<strong>in</strong>ated<br />
program<br />
7 145,61 3,354 2 546,08 3,304 91 990,60<br />
7 145,61 3,354 3 160,84 3,144 18 975,10<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>the</strong><br />
correct recurrence detection 7 145,61 3,322 2 853,46 3,129 64 896,88<br />
Maximal probability <strong>of</strong> <strong>the</strong><br />
correct recurrence detection<br />
Maximal probability <strong>of</strong> <strong>the</strong><br />
wrong recurrence detection<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>the</strong><br />
correct lack <strong>of</strong> recurrence<br />
detection<br />
Maximal probability <strong>of</strong> <strong>the</strong><br />
correct lack <strong>of</strong> recurrence<br />
detection<br />
Maximal probability <strong>of</strong> <strong>the</strong><br />
wrong lack <strong>of</strong> recurrence<br />
detection<br />
7 145,61 3,385 2 853,46 3,319 22 185,55<br />
7 145,61 3,322 2 853,46 3,129 64 896,88<br />
7 145,61 3,247 2 853,46 3,050 21 713,93<br />
7 145,61 3,460 2 853,46 3,398 69 772,90<br />
7 145,61 3,247 2 853,46 3,050 21 713,93<br />
Generally, <strong>the</strong> sensitivity <strong>analysis</strong> did not reveal any sudden costs and <strong>effect</strong>s changes, for<br />
<strong>the</strong> mentioned parameters alterations, characteriz<strong>in</strong>g compared diagnostic schemes. Head<br />
and neck malignant neoplasms recurrences diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> rema<strong>in</strong>s more expensive<br />
and more <strong>effect</strong>ive than <strong>CT</strong>, only <strong>in</strong> case <strong>of</strong> assum<strong>in</strong>g <strong>the</strong> maximal probability <strong>of</strong> <strong>the</strong> positive<br />
result <strong>in</strong> <strong>PET</strong>-<strong>CT</strong>, <strong>the</strong> program was dom<strong>in</strong>ated, i.e. <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation was more expensive<br />
and less efficient than computed tomography. The lowest ICER value was observed <strong>in</strong> case<br />
<strong>of</strong> assumption <strong>the</strong> alternative cost <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> procedure on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN (decrease<br />
<strong>of</strong> 74.60% from <strong>the</strong> basel<strong>in</strong>e value). Maximal ICER ratio value was observed <strong>in</strong> case <strong>of</strong><br />
assum<strong>in</strong>g <strong>the</strong> m<strong>in</strong>imal probability <strong>of</strong> ga<strong>in</strong><strong>in</strong>g positive <strong>CT</strong> result (ICER <strong>in</strong>crease <strong>of</strong> 178.62% from<br />
<strong>the</strong> basel<strong>in</strong>e value).<br />
28
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
2.3. PRIMARY TUMOR DETE<strong>CT</strong>ION IN CASE OF CERVICAL LYMPH<br />
NODES METASTASES FROM THE UNKNOWN PRIMARY ORIGIN<br />
SQUAMOUS CELL CARCINOMA<br />
2.3.1. Model description<br />
Model used <strong>in</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> concerns group <strong>of</strong> patients with head and<br />
neck lymph nodes <strong>in</strong>volved by <strong>the</strong> squamous cell carc<strong>in</strong>oma, undergo<strong>in</strong>g imag<strong>in</strong>g<br />
diagnostics to detect <strong>the</strong> primary tumor. <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> diagnostics <strong>effect</strong>s and costs were<br />
compared. Decision model, us<strong>in</strong>g a TreeAge ® 2004 (version 7) s<strong>of</strong>tware, was used <strong>in</strong> <strong>the</strong><br />
<strong>analysis</strong>. Time horizon was estimated until patient’s death, cost data were estimated from <strong>the</strong><br />
public payer’s perspective, on a basis <strong>of</strong> available <strong>in</strong>formation. The efficacy <strong>of</strong> <strong>the</strong> compared<br />
diagnostic methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical part <strong>of</strong> <strong>the</strong> report, entitled “Comparative cost<br />
– <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies<br />
f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics - epidemiological and<br />
cl<strong>in</strong>ical part”. Data concern<strong>in</strong>g <strong>the</strong> treatment <strong>effect</strong>s and consequences <strong>of</strong> <strong>the</strong> improper<br />
treatment, result<strong>in</strong>g from <strong>the</strong> misdiagnos<strong>in</strong>g, were obta<strong>in</strong>ed from <strong>the</strong> literature or from experts'<br />
estimation, <strong>in</strong> case <strong>of</strong> unavailable data.<br />
Information concern<strong>in</strong>g <strong>effect</strong>iveness <strong>of</strong> <strong>the</strong> diagnostic test to obta<strong>in</strong> correct estimation <strong>of</strong><br />
<strong>the</strong> patient as well as data concern<strong>in</strong>g diagnostic errors were <strong>in</strong>corporated <strong>in</strong>to <strong>the</strong> model.<br />
Improper diagnostics may cause health or f<strong>in</strong>ancial losses.<br />
2.3.2. Model’s transient states<br />
Decision model conta<strong>in</strong>s <strong>the</strong> follow<strong>in</strong>g transient states (equal for both variants <strong>of</strong> <strong>the</strong><br />
diagnostic procedure):<br />
• “Head and neck neoplasms” is a basel<strong>in</strong>e state, characteriz<strong>in</strong>g patients population<br />
at <strong>the</strong> beg<strong>in</strong>n<strong>in</strong>g <strong>of</strong> treatment. After <strong>the</strong> diagnostic procedure, <strong>the</strong>re is a possibility to<br />
pass <strong>in</strong>to <strong>the</strong> follow<strong>in</strong>g states:<br />
o Diagnosis: primary tumor (if <strong>the</strong> diagnostic procedure revealed primary head<br />
and neck malignant neoplasm);<br />
o Diagnosis: no primary tumor (if <strong>the</strong> primary head and neck malignant<br />
neoplasm was not detected).<br />
29
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• “Diagnosis: primary tumor” – conta<strong>in</strong>s patients with diagnosed head and neck<br />
malignant neoplasms primary tumor. If <strong>the</strong> primary tumor is diagnosed, <strong>the</strong> two f<strong>in</strong>al<br />
states may occur:<br />
o Patient with primary tumor (<strong>in</strong> case <strong>of</strong> correct primary tumor diagnosis);<br />
o Patient without primary tumor (if <strong>the</strong> primary tumor was <strong>in</strong>correctly diagnosed).<br />
• “Diagnosis: no primary tumor” – this state conta<strong>in</strong>s patients without diagnosed<br />
primary tumor <strong>of</strong> <strong>the</strong> head and neck malignant neoplasms. If no primary tumor was<br />
diagnosed, <strong>the</strong>re is a possibility to pass <strong>in</strong>to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Patient with primary tumor (if <strong>the</strong> lack <strong>of</strong> primary tumor was <strong>in</strong>correctly<br />
diagnosed);<br />
o Patient without primary tumor (if <strong>the</strong> lack <strong>of</strong> primary tumor was correctly<br />
diagnosed).<br />
The figure below shows <strong>the</strong> illustration <strong>of</strong> <strong>the</strong> decision tree <strong>of</strong> <strong>the</strong> model, describ<strong>in</strong>g <strong>the</strong><br />
course <strong>of</strong> head and neck malignant neoplasms primary tumor detection, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> and<br />
computed tomography.<br />
Figure 3.<br />
Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison, used <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> head<br />
and neck malignant neoplasms primary tumor (legend – table 24)<br />
As presented <strong>in</strong> <strong>the</strong> figure 3, it is assumed that all patients with positive result <strong>of</strong> diagnostic<br />
tests had radical surgical and radiological and palliative treatment, patients with negative<br />
result had chemo-radio<strong>the</strong>rapy and palliative treatment.<br />
2.3.3. <strong>Cost</strong>s calculation<br />
In <strong>the</strong> studies concern<strong>in</strong>g head and neck malignant neoplasms, <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> method was<br />
compared to <strong>the</strong> computed tomography with contrast media (<strong>CT</strong>). Computed tomography<br />
30
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
(<strong>CT</strong>) <strong>of</strong> <strong>the</strong> head is an out-patient, co-f<strong>in</strong>anced (ASDW) diagnostic service, that amounts 28<br />
po<strong>in</strong>ts – 23 po<strong>in</strong>ts are refunded by <strong>the</strong> National Health Fund and <strong>the</strong> 5 rema<strong>in</strong><strong>in</strong>g po<strong>in</strong>ts are<br />
covered by a physician referr<strong>in</strong>g to <strong>the</strong> procedure (“Catalogue <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced out-<br />
patient diagnostic procedures ranges (ASDW)”. Annex No. 1b to <strong>the</strong> <strong>in</strong>formational materials<br />
AOS). Referrer covers <strong>the</strong> cost <strong>of</strong> performed procedure, accord<strong>in</strong>g to <strong>the</strong> negotiated price <strong>of</strong><br />
<strong>the</strong> po<strong>in</strong>t. The National Health Fund covers <strong>the</strong> cost <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced diagnostic procedure,<br />
accord<strong>in</strong>gly to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by: health care provider perform<strong>in</strong>g <strong>the</strong><br />
procedure and by <strong>the</strong> referrer.<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on<br />
<strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories hav<strong>in</strong>g <strong>the</strong> contract<br />
with <strong>the</strong> National Health Fund <strong>in</strong> Poland, amounts 8.05 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> service from <strong>the</strong> ASDW catalogue,<br />
toge<strong>the</strong>r with its cost calculation.<br />
Table 19.<br />
Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
with contrast media<br />
Name and code <strong>of</strong><br />
<strong>the</strong> procedure<br />
<strong>CT</strong>: <strong>CT</strong> <strong>of</strong> <strong>the</strong> head<br />
with <strong>the</strong> contrast<br />
media<br />
5.03.00.0000025<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
<strong>CT</strong> laboratory Oncologic<br />
dispensary<br />
Test<br />
cost<br />
(PLN)<br />
23 5 8,05 7,54 222,85<br />
<strong>PET</strong>-<strong>CT</strong> is an <strong>in</strong>dividually contracted service, amount<strong>in</strong>g 420 po<strong>in</strong>ts. The average price <strong>of</strong><br />
<strong>the</strong> settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz,<br />
<strong>the</strong> sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
31
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 20.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
420 10,75<br />
Test cost [PLN]<br />
4 515,00<br />
The average <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> head and neck malignant<br />
neoplasm amounts 222.85 PLN, and <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong> public payer’s<br />
perspective – amounts 4,515.00 PLN.<br />
The follow<strong>in</strong>g table shows selected items, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services, used to<br />
calculate <strong>the</strong> costs <strong>of</strong> 6 cycles <strong>of</strong> chemo<strong>the</strong>rapy or 6 months <strong>of</strong> palliative chemo<strong>the</strong>rapy.<br />
Table 21.<br />
<strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services<br />
Type <strong>of</strong> <strong>the</strong><br />
<strong>the</strong>rapy<br />
PF<br />
Active substances Posology<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
100 mg/m 2 iv / day 1 // 800–1000 mg/m 2 iv<br />
days 1–4 (CONTINUOUS INFUSION 96 H<br />
WITH/WITHOUT RADIOTHERAPY)<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong><br />
procedure =No<br />
<strong>of</strong> po<strong>in</strong>ts x po<strong>in</strong>t<br />
price (10 PLN)<br />
[PLN]<br />
7 148,40<br />
MTX METHOTREXATUM 40 mg/m 2 iv day 1, every 7 days 3 098,40<br />
PFH&N<br />
PFELVH&N<br />
PF1<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
CIS-PLATINUM //<br />
FLUOROURACILUM //<br />
VINBLASTINUM // ETOPOSIDUM<br />
// CALCII FOLINAS<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
P CIS-PLATINUM<br />
20 mg/m 2 /day iv (cont<strong>in</strong>uous <strong>in</strong>fusion) days<br />
1–5 //<br />
500 mg/m 2 /day iv ( cont<strong>in</strong>uous <strong>in</strong>fusion)days<br />
1–7 and days 15, 22, 29 every 28 days<br />
30 mg/m 2 iv days 1–3 // 500 mg/m 2 iv days 1–<br />
3 // 3 mg/m 2 iv day 1 // 100 mg/m 2 iv days 2<br />
and 3 // 25 mg/m 2 iv days 1–3 every 21 days<br />
25 mg/m 2 iv days 1–4 // 1000 mg/m 2 iv days 1-<br />
4 every 28 days<br />
40 mg/m 2 iv day 1, every 7 days IN<br />
COMBINATION WITH RADIOTHERAPY<br />
13 963,20<br />
6 376,80<br />
7 148,40<br />
3 636,00<br />
Table 22 conta<strong>in</strong>s selected radio<strong>the</strong>rapeutic procedures, from <strong>the</strong> NHF’s catalogue <strong>of</strong><br />
services, used <strong>in</strong> head and neck malignant neoplasms treatment, as well as its cost.<br />
32
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 22.<br />
<strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services<br />
Type <strong>of</strong> service<br />
Code <strong>of</strong> <strong>the</strong><br />
procedure<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure =No <strong>of</strong> po<strong>in</strong>ts<br />
x po<strong>in</strong>t price (10 PLN) [PLN]<br />
palliative teleradio<strong>the</strong>rapy 5.07.01.0000021 1 800<br />
radical teleradio<strong>the</strong>rapy with twodimensional<br />
(2D) plann<strong>in</strong>g<br />
radical teleradio<strong>the</strong>rapy with threedimensional<br />
(3D) plann<strong>in</strong>g<br />
5.07.01.0000022 5 000<br />
5.07.01.0000023 8 000<br />
standard brachy<strong>the</strong>rapy 5.07.01.0000025 4 000<br />
3D brachy<strong>the</strong>rapy with real time plann<strong>in</strong>g 5.07.01.0000026 5 200<br />
The table below conta<strong>in</strong>s selected procedures, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services as well<br />
as cost <strong>of</strong> operative treatment <strong>of</strong> head and neck malignant neoplasms.<br />
Table 23.<br />
Surgical procedures used <strong>in</strong> head and neck malignant neoplasms treatment<br />
Name <strong>of</strong> <strong>the</strong> procedure Code <strong>of</strong> <strong>the</strong> procedure<br />
excision <strong>of</strong> <strong>the</strong> maxillary neoplasm – partial<br />
and total resection <strong>of</strong> <strong>the</strong> maxilla<br />
Total or partial laryngectomy with <strong>the</strong> lymph<br />
nodes operation / with or without CO2 laser /<br />
with tracheostomy<br />
Radical or modified excision <strong>of</strong> <strong>the</strong> cervical<br />
lymphatic <strong>system</strong><br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx with cervical lymph nodes<br />
excision<br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx with cervical lymph nodes<br />
excision, mandibulotomy and/or without partial<br />
mandible resection<br />
Salivary gland neoplasm excision with cervical<br />
lymphangiectomy<br />
Mandible excision (hemiresection) with<br />
possible cervical lymphangiectomy<br />
Parotid gland neoplasm excision with <strong>the</strong> facial<br />
nerve reconstruction or with facial nerve<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure<br />
=No <strong>of</strong> po<strong>in</strong>ts x po<strong>in</strong>t price<br />
(10 PLN) [PLN]<br />
5.06.00.0000481 7 000<br />
5.06.00.0000682 5 200<br />
5.06.00.0000689 4 800<br />
5.06.00.0000479 7 000<br />
5.06.00.0000480 8 000<br />
5.06.00.0000482 5 000<br />
5.06.00.0000483 6 000<br />
5.06.00.0000484 4 500<br />
33
preservation<br />
Eyelid neoplasm, exceed<strong>in</strong>g over <strong>the</strong> orbit<br />
outl<strong>in</strong>e – surgical treatment<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
5.06.00.0000134 2 000<br />
Nose neoplasm excision 5.06.00.0000160 2 600<br />
Sk<strong>in</strong>/s<strong>of</strong>t tissue neoplasm excision with<br />
syn<strong>the</strong>tic implants reconstruction or with<br />
pedunculated lobes<br />
5.06.00.0000161 3 800<br />
Orbit neoplasm – surgical treatment 5.06.00.0000214 5 000<br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx<br />
2.3.4. Model parameters<br />
Ma<strong>in</strong> model parameters are presented <strong>in</strong> <strong>the</strong> table below.<br />
5.06.00.0000478 5 000<br />
Table 24.<br />
List <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong> primary tumor<br />
<strong>of</strong> head and neck malignant neoplasms diagnostics<br />
Parameter <strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> diagnostic procedure<br />
[PLN]<br />
<strong>Cost</strong> <strong>of</strong> palliative <strong>the</strong>rapy (cPaliat)<br />
[PLN]<br />
<strong>Cost</strong> <strong>of</strong> palliative <strong>the</strong>rapy (cPaliat2)<br />
[PLN]<br />
4 515,00 (1 313,00*) 222,85 (174,50; 274,00)<br />
7 148,40 (3 098,40; 13 963,20)<br />
7 148,40 (5 718,72; 8 578,08)<br />
<strong>Cost</strong> <strong>of</strong> chemo<strong>the</strong>rapy (cChem) [PLN] 7 148,40**<br />
<strong>Cost</strong> <strong>of</strong> radio<strong>the</strong>rapy (cRT) [PLN] 5 000,00 (1 800,00; 8 000,00)<br />
<strong>Cost</strong> <strong>of</strong> radical <strong>the</strong>rapy (cLeczRadyk)<br />
[PLN]<br />
Survival <strong>in</strong> case <strong>of</strong> lack <strong>of</strong> tumor or<br />
resective tumor (eP_LeczRadyk)<br />
[years]<br />
Survival <strong>in</strong> case <strong>of</strong> non-diagnosed<br />
tumor – wrong diagnosis<br />
(eP_GuzUkryty) [years]<br />
Probability <strong>of</strong> diagnostic procedure<br />
positive result (TP+FP)<br />
5 000,00 (2 000,00; 16 000,00)<br />
5,0 (4,0; 6,0)<br />
4,0 (3,0; 5,0)<br />
0,3680 (0,3249; 0,4111)<br />
34
Probability <strong>of</strong> <strong>the</strong> correct primary<br />
tumor detection (pTP)<br />
Probability <strong>of</strong> wrong primary tumor<br />
detection (pFP)<br />
Probability <strong>of</strong> correct lack <strong>of</strong> primary<br />
tumor detection (pTN)<br />
Probability <strong>of</strong> <strong>in</strong>correct lack <strong>of</strong><br />
primary tumor detection (pFN)<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
0,9783 (0,9568; 0,9998) 0,7391 (0,6744; 0,8039)<br />
0,0217 (0,0002; 0,0432) 0,2609 (0,1961; 0,3256)<br />
0,9241 (0,8850; 0,9631) 0,7468 (0,6827; 0,8109)<br />
0,0759 (0,0369; 0,1150) 0,2532 (0,1891; 0,3173)<br />
*“threshold” <strong>PET</strong>-<strong>CT</strong> cost at 7,700 procedures per year (estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report);<br />
** only chemo<strong>the</strong>rapeutic regimen used <strong>in</strong> “unknown primary orig<strong>in</strong> neoplasms – squamous cell carc<strong>in</strong>oma”<br />
<strong>in</strong>dication.<br />
• <strong>PET</strong>-<strong>CT</strong> cost amounts 4,515.00 PLN (alternative <strong>PET</strong>-<strong>CT</strong> cost, amount<strong>in</strong>g 1,313.00 PLN<br />
was also assumed – cost estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report).<br />
• The average <strong>CT</strong> cost amounts 222.85; m<strong>in</strong>imal cost <strong>of</strong> this procedure amounted 174.50<br />
PLN, maximal – 274.00 PLN.<br />
• The average cost <strong>of</strong> head and neck malignant neoplasms radical treatment was<br />
assumed as equal to <strong>the</strong> cost <strong>of</strong> procedure 5.06.00.0000482 from <strong>the</strong> catalogue <strong>of</strong> <strong>the</strong><br />
hospital services (<strong>the</strong> costs range between m<strong>in</strong>imal and maximal cost <strong>of</strong> surgical<br />
procedures used <strong>in</strong> head and neck malignant tumors treatment – see: table 23).<br />
• As <strong>the</strong> average cost <strong>of</strong> palliative treatment (cPaliat) and chemo<strong>the</strong>rapy (cChem), <strong>in</strong><br />
case <strong>of</strong> no primary tumor, <strong>the</strong> cost <strong>of</strong> 6 cycles <strong>of</strong> PF chemo<strong>the</strong>rapy (form <strong>the</strong><br />
oncologic procedures catalogue) was assumed (<strong>the</strong> range between m<strong>in</strong>imal and<br />
maximal cost <strong>of</strong> palliative chemo<strong>the</strong>rapy, used <strong>in</strong> head and neck malignant tumors<br />
treatment – see: table 21).<br />
• <strong>Cost</strong> <strong>of</strong> <strong>the</strong> palliative treatment (cPaliat2) was assumed as equal to <strong>the</strong> cost <strong>of</strong> 6<br />
cycles <strong>of</strong> PF chemo<strong>the</strong>rapy, from <strong>the</strong> oncologic services catalogue, used <strong>in</strong> unknown<br />
primary orig<strong>in</strong> cancers treatment (range +/_ 1 cycle <strong>of</strong> treatment).<br />
• The average cost <strong>of</strong> unknown primary orig<strong>in</strong> cancers <strong>in</strong>volv<strong>in</strong>g cervical lymph nodes<br />
radio<strong>the</strong>rapy was assumed as <strong>the</strong> cost <strong>of</strong> procedure No. 5.07.01.0000022 from <strong>the</strong><br />
oncologic services catalogue – teleradio<strong>the</strong>rapy, brachy<strong>the</strong>rapy and isotope <strong>the</strong>rapy<br />
(range between m<strong>in</strong>imal and maximal cost <strong>of</strong> <strong>the</strong> procedures used <strong>in</strong> head and neck<br />
malignant neoplasms treatment – see table 23).<br />
• M<strong>in</strong>imal and maximal life expectancy values <strong>in</strong> case <strong>of</strong> detected primary tumor, real<br />
lack <strong>of</strong> primary tumor and <strong>in</strong> case <strong>of</strong> <strong>the</strong> primary tumor not detected with imag<strong>in</strong>g<br />
35
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
studies, were assumed on a basis <strong>of</strong> <strong>the</strong> literature and estimation <strong>of</strong> experts from <strong>the</strong><br />
Maria – Curie Skłodowska Memorial Institute Center <strong>of</strong> Oncology <strong>in</strong> Warsaw.<br />
• Values <strong>of</strong> <strong>the</strong> rest <strong>of</strong> parameters were taken from <strong>the</strong> report: “Comparative cost –<br />
<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic<br />
technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics -<br />
epidemiological and cl<strong>in</strong>ical part”. Information from <strong>the</strong> follow<strong>in</strong>g publications were<br />
used:<br />
o Branstetter IV BF, Blodgett TM, Zimmer LA, Snyderman CH, Johnson JT, Raman<br />
2.3.5. Results<br />
S, Meltzer CC. Head and neck malignancy: Is <strong>PET</strong>-<strong>CT</strong> more accurate than <strong>PET</strong><br />
or <strong>CT</strong> alone?. Radiology 2005; Vol. 235 (2): pp 580–586.<br />
The follow<strong>in</strong>g table shows results <strong>of</strong> <strong>the</strong> comparative cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs<br />
computed tomography used <strong>in</strong> head and neck malignant neoplasms primary tumors<br />
diagnostics, where <strong>the</strong> average life expectancy expressed <strong>in</strong> years, was considered as <strong>the</strong><br />
<strong>effect</strong>. Cohort simulation method was used <strong>in</strong> calculations.<br />
Table 25.<br />
Results <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm primary<br />
tumor diagnostics<br />
Procedure<br />
<strong>Cost</strong> per one<br />
patient [PLN]<br />
<strong>Cost</strong> difference<br />
[PLN]<br />
Average life<br />
expectancy<br />
[years]<br />
<strong>PET</strong>-<strong>CT</strong> 21 181,19 4,952<br />
<strong>CT</strong> 16 889,04<br />
4 292,15<br />
4,840<br />
Effects<br />
difference<br />
(LYG)<br />
ICER<br />
[PLN/LYG]<br />
0,112 38 322,77<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> revealed, that head and neck malignant neoplasms <strong>of</strong><br />
unknown primary orig<strong>in</strong> diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more expensive than us<strong>in</strong>g computed<br />
tomography, but simultaneously gives a better long-term <strong>effect</strong>, measured with life years<br />
ga<strong>in</strong>ed ratio. <strong>PET</strong>-<strong>CT</strong> cost <strong>in</strong>cluded costs <strong>of</strong> <strong>the</strong> diagnostic procedure, surgical treatment and<br />
costs <strong>of</strong> palliative chemo<strong>the</strong>rapy. The cost difference between diagnostic procedures<br />
amounts 4,292.15 PLN per one patient. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong> one patient allows to ga<strong>in</strong> 4.952 life<br />
years. In a group <strong>of</strong> patients, where computed tomography is performed, <strong>the</strong> anticipated<br />
<strong>effect</strong> amounts 4.840 life years. Difference <strong>of</strong> <strong>effect</strong>s between <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> amounts 0.112<br />
LYG (life years ga<strong>in</strong>ed) i.e. approx. 41 days.<br />
36
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Head and neck malignant neoplasms primary tumor diagnostics, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>system</strong> is<br />
more expensive, but more <strong>effect</strong>ive than computed tomography diagnostics. Incremental<br />
cost-<strong>effect</strong>iveness ratio amounts 38,322.77 PLN/LYG, that means, ga<strong>in</strong><strong>in</strong>g one additional year<br />
<strong>of</strong> life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, costs 38,322.77 PLN.<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> was also performed us<strong>in</strong>g Monte Carlo simulation method for<br />
100,000 patients. Results are shown <strong>in</strong> <strong>the</strong> table below.<br />
Table 26.<br />
Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck<br />
malignant neoplasm primary tumor diagnostics<br />
Parameter<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> [PLN] Effect [years] <strong>Cost</strong> [PLN] Effect [years]<br />
ICER<br />
[PLN/LYG]<br />
Average 21 190,30 4,951 16 898,15 4,840 38 668,02<br />
Standard deviation 3 444,89 0,215 3 444,89 0,366<br />
M<strong>in</strong>imal value 16 663,40 4,000 12 371,25 4,000<br />
Median 23 811,80 5,000 19 519,65 5,000<br />
Maximal value 23 811,80 5,000 19 519,65 5,000<br />
Results obta<strong>in</strong>ed us<strong>in</strong>g <strong>the</strong> Monte Carlo method do not differ from results obta<strong>in</strong>ed <strong>in</strong> <strong>the</strong><br />
cohort simulation method. <strong>PET</strong>-<strong>CT</strong> diagnostics method rema<strong>in</strong>s more expensive and more<br />
<strong>effect</strong>ive than us<strong>in</strong>g computed tomography only. Difference <strong>of</strong> <strong>effect</strong>s averages amounts<br />
0.111 <strong>of</strong> a life year. Median <strong>of</strong> <strong>the</strong> <strong>effect</strong> <strong>in</strong> a group <strong>of</strong> patient diagnosed us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong><br />
amounts 5 life years, and <strong>in</strong> <strong>CT</strong> group – also 5 life years. Incremental cost-<strong>effect</strong>iveness ratio<br />
amounts 38,668.02 PLN/LYG that means, ga<strong>in</strong><strong>in</strong>g one additional year <strong>of</strong> life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong><br />
diagnostics <strong>in</strong> head and neck malignant neoplasms primary tumor detection, <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>,<br />
costs 38,668.02 PLN.<br />
2.3.6. Sensitivity <strong>analysis</strong><br />
One-way sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> diagnostics <strong>in</strong> head and neck malignant<br />
neoplasms primary tumors detection was performed for <strong>the</strong> different model parameters;<br />
-<br />
37
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• assumption <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> cost on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN (“subthreshold” <strong>PET</strong>-<strong>CT</strong> cost at<br />
7,700 procedures per year, estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong><br />
<strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report);<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> <strong>CT</strong>;<br />
• assumption <strong>of</strong> <strong>the</strong> alternative cost <strong>of</strong> <strong>the</strong> <strong>CT</strong>, amount<strong>in</strong>g 335.55 PLN – one or more<br />
parts <strong>of</strong> <strong>the</strong> body exam<strong>in</strong>ation;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> radical treatment;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> radio<strong>the</strong>rapy;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> palliative treatment;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> palliative treatment (2);<br />
• m<strong>in</strong>imal and maximal life expectancy, <strong>in</strong> case <strong>of</strong> lack <strong>of</strong> tumor or <strong>in</strong> case <strong>of</strong> resective<br />
tumor;<br />
• m<strong>in</strong>imal and maximal life expectancy, <strong>in</strong> case <strong>of</strong> lack <strong>of</strong> tumor or <strong>in</strong> case <strong>of</strong> hidden<br />
tumor – wrong diagnosis;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> ga<strong>in</strong><strong>in</strong>g a positive result <strong>in</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong>;<br />
• maximal probability <strong>of</strong> <strong>the</strong> correct primary tumor detection;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> <strong>the</strong> correct diagnosis concern<strong>in</strong>g <strong>the</strong> lack <strong>of</strong><br />
primary tumor.<br />
Sensitivity <strong>analysis</strong> results for <strong>the</strong> variable model parameters are shown <strong>in</strong> table below.<br />
Table 27.<br />
Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm primary tumor diagnostics<br />
Parameter<br />
<strong>Cost</strong> [PLN]<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
Effect<br />
[years]<br />
<strong>Cost</strong> [PLN]<br />
Effect<br />
[years]<br />
ICER [PLN/LYG]<br />
Basel<strong>in</strong>e state 21 181,19 4,952 16 889,04 4,840 38 322,77<br />
Alternative <strong>PET</strong>-<strong>CT</strong> cost 17 979,19 4,952 16 889,04 4,840 9 733,48<br />
M<strong>in</strong>imal cost <strong>of</strong> <strong>CT</strong> 21 181,19 4,952 16 840,69 4,840 38 754,46<br />
Maximal cost <strong>of</strong> <strong>CT</strong> 21 181,19 4,952 16 940,19 4,840 37 866,07<br />
Alternative cost <strong>of</strong> <strong>CT</strong> 21 181,19 4,952 17 001,74 4,840 37 316,52<br />
M<strong>in</strong>imal cost <strong>of</strong> radical<br />
treatment<br />
20 077,19 4,952 15 785,04 4,840 38 322,77<br />
38
Maximal cost <strong>of</strong> radical<br />
treatment<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
25 229,19 4,952 20 937,04 4,840 38 322,77<br />
M<strong>in</strong>imal cost <strong>of</strong> radio<strong>the</strong>rapy 19 158,79 4,952 14 866,64 4,840 38 322,77<br />
Maximal cost <strong>of</strong> radio<strong>the</strong>rapy 23 077,19 4,952 18 785,04 4,840 38 322,77<br />
M<strong>in</strong>imal cost <strong>of</strong> palliative<br />
chemo<strong>the</strong>rapy<br />
Maximal cost <strong>of</strong> palliative<br />
chemo<strong>the</strong>rapy<br />
M<strong>in</strong>imal cost <strong>of</strong> palliative<br />
chemo<strong>the</strong>rapy (2)<br />
Maximal cost <strong>of</strong> palliative<br />
chemo<strong>the</strong>rapy (2)<br />
19 528,86 4,952 15 139,39 4,840 39 191,70<br />
23 961,51 4,952 19 833,11 4,840 36 860,71<br />
20 334,79 4,952 16 077,00 4,840 38 015,98<br />
22 027,58 4,952 17 701,08 4,840 38 629,46<br />
M<strong>in</strong>imal survival <strong>in</strong> case <strong>of</strong> lack<br />
<strong>of</strong> tumor or resective tumor 21 181,19 4,000 16 889,04 4,000<br />
Maximal survival <strong>in</strong> case <strong>of</strong> lack<br />
<strong>of</strong> tumor or resective tumor<br />
M<strong>in</strong>imal survival <strong>in</strong> case <strong>of</strong><br />
hidden tumor – wrong diagnosis<br />
Dom<strong>in</strong>ated<br />
program<br />
21 181,19 5,904 16 889,04 5,680 19 161,38<br />
21 181,19 4,904 16 889,04 4,680 19 161,38<br />
Maximal survival <strong>in</strong> case <strong>of</strong><br />
hidden tumor – wrong diagnosis 21 181,19 5,000 16 889,04 5,000<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
diagnostic procedure positive<br />
result<br />
Maximal probability <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
diagnostic procedure positive<br />
result<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>CT</strong><br />
diagnostic procedure positive<br />
result<br />
Maximal probability <strong>of</strong> <strong>CT</strong><br />
diagnostic procedure positive<br />
result<br />
Maximal probability <strong>of</strong> <strong>the</strong><br />
correct primary tumor detection<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>the</strong><br />
correct lack <strong>of</strong> primary tumor<br />
detection<br />
Maximal probability <strong>of</strong> <strong>the</strong><br />
correct lack <strong>of</strong> primary tumor<br />
detection<br />
Dom<strong>in</strong>ated<br />
program<br />
21 488,57 4,949 16 889,04 4,840 42 197,52<br />
20 873,81 4,955 16 889,04 4,840 34 650,17<br />
21 181,19 4,952 17 196,42 4,829 32 396,50<br />
21 181,19 4,952 16 581,66 4,851 45 539,90<br />
21 181,19 4,952 16 889,04 4,840 38 322,77<br />
21 181,19 4,927 16 889,04 4,799 33 570,71<br />
21 181,19 4,977 16 889,04 4,880 44 621,58<br />
Generally, <strong>the</strong> sensitivity <strong>analysis</strong> did not reveal any sudden costs and <strong>effect</strong>s changes, for<br />
<strong>the</strong> mentioned parameters alterations, characteriz<strong>in</strong>g compared diagnostic schemes. Head<br />
and neck malignant neoplasms primary tumors diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> rema<strong>in</strong>s more<br />
39
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
expensive and more <strong>effect</strong>ive than <strong>CT</strong> diagnostics, only if <strong>the</strong> m<strong>in</strong>imal survival <strong>in</strong> case <strong>of</strong> lack<br />
<strong>of</strong> tumor or resective tumor is assumed or <strong>in</strong> case <strong>of</strong> <strong>the</strong> maximal survival <strong>of</strong> patients with<br />
hidden tumor (wrong diagnosis) <strong>the</strong> program was dom<strong>in</strong>ated, i.e. <strong>PET</strong>-<strong>CT</strong> diagnostics was<br />
more expensive and equally <strong>effect</strong>ive as <strong>CT</strong> diagnostics. The lowest ICER value was observed<br />
<strong>in</strong> case <strong>of</strong> assumption <strong>the</strong> alternative cost <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> procedure on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN<br />
(decrease <strong>of</strong> 74.60% from <strong>the</strong> basel<strong>in</strong>e value). Maximal ICER ratio value was observed <strong>in</strong> case<br />
<strong>of</strong> assum<strong>in</strong>g <strong>the</strong> maximal probability <strong>of</strong> ga<strong>in</strong><strong>in</strong>g positive <strong>CT</strong> result (ICER <strong>in</strong>crease <strong>of</strong> 18.83% from<br />
<strong>the</strong> basel<strong>in</strong>e value).<br />
2.4. LITERATURE<br />
1. Branstetter IV BF, Blodgett TM, Zimmer LA, Snyderman CH, Johnson JT, Raman S, Meltzer CC. Head<br />
and neck malignancy: Is <strong>PET</strong>-<strong>CT</strong> more accurate than <strong>PET</strong> or <strong>CT</strong> alone?. Radiology 2005; Vol. 235 (2):<br />
pp 580–586.<br />
2. O'Malley BW, Chemo<strong>the</strong>rapy and Radiation for Advanced Head and Neck Cancer, Baylor College<br />
<strong>of</strong> Medic<strong>in</strong>e December 10, 1992.<br />
3. Bernier J, Domenge C, Ozsah<strong>in</strong> M, et al. Postoperative irradiation with or without concomitant<br />
chemo<strong>the</strong>rapy for locally advanced head and neck cancer. The New England Journal <strong>of</strong> Medic<strong>in</strong>e<br />
6 May 2004; 350 (19): pp 1945–1952.<br />
4. Cooper JS, Pajak TF, Forastiere AA, et al. Postoperative concurrent radio<strong>the</strong>rapy and chemo<strong>the</strong>rapy<br />
for high-risk squamous-cell carc<strong>in</strong>oma <strong>of</strong> <strong>the</strong> head and neck. The New England Journal <strong>of</strong> Medic<strong>in</strong>e<br />
6 May 2004; 350 (19): pp 1937–1944.<br />
5. The Surveillance, Epidemiology, and End Results (SEER) Program <strong>of</strong> <strong>the</strong> National Cancer Institute<br />
(NCI) [http://seer.cancer.gov].<br />
40
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
3. NON-SMALL CELL LUNG CANCER – COST-EFFE<strong>CT</strong>IVENESS<br />
ANALYSIS – <strong>PET</strong>-<strong>CT</strong> VS <strong>CT</strong> DIAGNOSTICS<br />
In <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> compar<strong>in</strong>g <strong>the</strong> non-small cell lung cancer cl<strong>in</strong>ical<br />
advancement us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> a decision model <strong>of</strong> preoperative non-small cell lung<br />
cancer stag<strong>in</strong>g (accord<strong>in</strong>gly to <strong>the</strong> TNM scale) used to confirm or modify <strong>the</strong> planned<br />
treatment was used.<br />
The efficacy <strong>of</strong> <strong>the</strong> compared diagnostic methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical part <strong>of</strong> <strong>the</strong><br />
report, entitled “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<br />
<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic<br />
diagnostics - epidemiological and cl<strong>in</strong>ical part”. Cl<strong>in</strong>ical <strong>effect</strong>s were estimated on a basis <strong>of</strong><br />
available data from studies or experts’ estimations. <strong>Cost</strong>s, from <strong>the</strong> Polish public payer’s<br />
perspective were estimated on a basis <strong>of</strong> <strong>the</strong> available data concern<strong>in</strong>g procedures used <strong>in</strong><br />
lung cancer treatment, <strong>in</strong> a time horizon equal to patients’ life expectancy.<br />
3.1. MODEL DESCRIPTION<br />
Model used <strong>in</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> concerns a group <strong>of</strong> patients with a non-small<br />
cell lung cancer, qualified, on a basis <strong>of</strong> <strong>the</strong> prelim<strong>in</strong>ary cl<strong>in</strong>ical assessment, to <strong>the</strong> surgical<br />
procedure. <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> diagnostics <strong>effect</strong>s and costs were compared. Decision model,<br />
us<strong>in</strong>g a TreeAge ® 2004 (version 7) s<strong>of</strong>tware, was used <strong>in</strong> <strong>the</strong> <strong>analysis</strong>. Time horizon was<br />
estimated until patient’s death, cost data were estimated from <strong>the</strong> public payer’s<br />
perspective, on a basis <strong>of</strong> available <strong>in</strong>formation. The efficacy <strong>of</strong> <strong>the</strong> compared diagnostic<br />
methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical part <strong>of</strong> <strong>the</strong> report, entitled “Comparative cost – <strong>effect</strong><br />
<strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong><br />
Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics - epidemiological and cl<strong>in</strong>ical<br />
part”. Data concern<strong>in</strong>g <strong>the</strong> treatment <strong>effect</strong>s and consequences <strong>of</strong> <strong>the</strong> improper treatment,<br />
result<strong>in</strong>g from <strong>the</strong> misdiagnos<strong>in</strong>g, were obta<strong>in</strong>ed from <strong>the</strong> literature or from experts'<br />
estimation, <strong>in</strong> case <strong>of</strong> unavailable data.<br />
Information concern<strong>in</strong>g <strong>effect</strong>iveness <strong>of</strong> <strong>the</strong> diagnostic test to obta<strong>in</strong> correct estimation <strong>of</strong><br />
<strong>the</strong> patient as well as data concern<strong>in</strong>g diagnostic errors were <strong>in</strong>corporated <strong>in</strong>to <strong>the</strong> model.<br />
Improper diagnostics may cause health or f<strong>in</strong>ancial losses.<br />
41
3.2. MODEL’S TRANSIENT STATES<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Decision model conta<strong>in</strong>s <strong>the</strong> follow<strong>in</strong>g transient states (equal for both variants <strong>of</strong> <strong>the</strong><br />
diagnostic procedure):<br />
• “Non-small cell lung cancer” is a basel<strong>in</strong>e state, characteriz<strong>in</strong>g patients’ population<br />
at <strong>the</strong> beg<strong>in</strong>n<strong>in</strong>g <strong>of</strong> treatment. After <strong>the</strong> diagnostic procedure, <strong>the</strong>re is a possibility to<br />
pass <strong>in</strong>to <strong>the</strong> follow<strong>in</strong>g states:<br />
o Diagnosis: stage I (if <strong>the</strong> diagnostic procedure revealed stage I <strong>of</strong> <strong>the</strong> disease<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Diagnosis: stage II (if <strong>the</strong> diagnostic procedure revealed stage II <strong>of</strong> <strong>the</strong> disease<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Diagnosis: stage IIIA (if <strong>the</strong> diagnostic procedure revealed stage IIIA <strong>of</strong> <strong>the</strong><br />
disease accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Diagnosis: stage IIIB (if <strong>the</strong> diagnostic procedure revealed stage IIIB <strong>of</strong> <strong>the</strong><br />
disease accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Diagnosis: stage IV (if <strong>the</strong> diagnostic procedure revealed stage IV <strong>of</strong> <strong>the</strong><br />
disease accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
• “Diagnosis: stage I" – <strong>in</strong>cludes patients with prelim<strong>in</strong>arily diagnosed I st stage <strong>of</strong> <strong>the</strong><br />
disease, accord<strong>in</strong>gly to <strong>the</strong> TNM scale. Patient diagnosed with I st stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale, may pass to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Patient <strong>in</strong> stage I (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> I st stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage II (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> II nd stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIA (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd A stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIB (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd B stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IV (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> IV th stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly<br />
to <strong>the</strong> TNM scale).<br />
• “Diagnosis: stage II" – <strong>in</strong>cludes patients with prelim<strong>in</strong>arily diagnosed II nd stage <strong>of</strong> <strong>the</strong><br />
disease, accord<strong>in</strong>gly to <strong>the</strong> TNM scale. Patient diagnosed with II nd stage <strong>of</strong> <strong>the</strong><br />
disease, accord<strong>in</strong>gly to <strong>the</strong> TNM scale, may pass to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Patient <strong>in</strong> stage I (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> I st stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
42
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
o Patient <strong>in</strong> stage II (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> II nd stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIA (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd A stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIB (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd B stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IV (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> IV th stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly<br />
to <strong>the</strong> TNM scale).<br />
• “Diagnosis: stadium IIIA” – obejmuje chorych, u których zdiagnozowano wystąpienie<br />
stadium IIIA choroby zgodnie ze skalą TNM. Patient diagnosed with III rd A stage <strong>of</strong> <strong>the</strong><br />
disease, accord<strong>in</strong>gly to <strong>the</strong> TNM scale, may pass to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Patient <strong>in</strong> stage I (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> I st stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage II (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> II nd stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIA (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd A stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIB (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd B stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IV (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> IV th stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly<br />
to <strong>the</strong> TNM scale).<br />
• “Diagnosis: stage IIIB" – <strong>in</strong>cludes patients with prelim<strong>in</strong>arily diagnosed III rd B stage <strong>of</strong> <strong>the</strong><br />
disease, accord<strong>in</strong>gly to <strong>the</strong> TNM scale. Patient diagnosed with III rd B stage <strong>of</strong> <strong>the</strong><br />
disease, accord<strong>in</strong>gly to <strong>the</strong> TNM scale, may pass to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Patient <strong>in</strong> stage I (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> I st stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage II (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> II nd stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIA (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd A stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIB (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd B stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IV (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> IV th stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly<br />
to <strong>the</strong> TNM scale).<br />
43
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• “Diagnosis: stage IV" – <strong>in</strong>cludes patients with prelim<strong>in</strong>arily diagnosed IV th stage <strong>of</strong> <strong>the</strong><br />
disease, accord<strong>in</strong>gly to <strong>the</strong> TNM scale. Patient diagnosed with IV th stage <strong>of</strong> <strong>the</strong><br />
disease, accord<strong>in</strong>gly to <strong>the</strong> TNM scale, may pass to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Patient <strong>in</strong> stage I (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> I st stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage II (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> II nd stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly to<br />
<strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIA (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd A stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IIIB (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> III rd B stage <strong>of</strong> <strong>the</strong> disease,<br />
accord<strong>in</strong>gly to <strong>the</strong> TNM scale);<br />
o Patient <strong>in</strong> stage IV (if <strong>the</strong> patient is <strong>in</strong> <strong>the</strong> IV th stage <strong>of</strong> <strong>the</strong> disease, accord<strong>in</strong>gly<br />
to <strong>the</strong> TNM scale).<br />
The follow<strong>in</strong>g figure shows <strong>the</strong> illustration <strong>of</strong> <strong>the</strong> decision tree <strong>of</strong> <strong>the</strong> model, describ<strong>in</strong>g <strong>the</strong><br />
course <strong>of</strong> treatment patients who had <strong>the</strong> lung cancer cl<strong>in</strong>ical advancement diagnosed with<br />
<strong>PET</strong>-<strong>CT</strong> and computed tomography.<br />
44
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Figure 4.<br />
Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> <strong>the</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison, used <strong>in</strong> <strong>the</strong> non-small cell lung<br />
cancer cl<strong>in</strong>ical advancement assessment (legend – table 33)<br />
As presented <strong>in</strong> <strong>the</strong> figure 4, it is assumed that all patients with stage IIIA <strong>in</strong> diagnostic tests<br />
had surgical and chemo<strong>the</strong>rapy treatment, all patients with stage IIIB result had chemo-<br />
radio<strong>the</strong>rapy, all patients with stage IV result had chemo<strong>the</strong>rapy, patients correctly<br />
diagnosed as I and II stage had radical surgical treatment, underestimated as I and II stage<br />
patients with higher stages had surgical treatment and additionally chemo<strong>the</strong>rapy.<br />
45
3.3. COSTS CALCULATION<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
In a study concern<strong>in</strong>g <strong>the</strong> lung cancer diagnostics, <strong>the</strong> hybrid <strong>PET</strong>-<strong>CT</strong> was compared to <strong>the</strong><br />
computed tomography (<strong>CT</strong>). Computed tomography is and out-patient diagnostic service,<br />
co-f<strong>in</strong>anced (ASDW), that amounts 42 po<strong>in</strong>ts – 37 po<strong>in</strong>ts are refunded by <strong>the</strong> National Health<br />
Fund and <strong>the</strong> 5 po<strong>in</strong>ts are covered by a physician referr<strong>in</strong>g to <strong>the</strong> procedure (“Catalogue <strong>of</strong><br />
<strong>the</strong> co-f<strong>in</strong>anced out-patient diagnostic procedures ranges (ASDW)”. Annex No. 1b to <strong>the</strong><br />
<strong>in</strong>formational materials AOS). Referrer covers <strong>the</strong> cost <strong>of</strong> performed procedure, accord<strong>in</strong>g to<br />
<strong>the</strong> negotiated price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t. The National Health Fund covers <strong>the</strong> cost <strong>of</strong> <strong>the</strong> co-<br />
f<strong>in</strong>anced diagnostic procedure, accord<strong>in</strong>gly to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by: health<br />
care provider perform<strong>in</strong>g <strong>the</strong> procedure and by <strong>the</strong> referrer.<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on a<br />
basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories bounded with <strong>the</strong> National<br />
Health Fund contract <strong>in</strong> Poland, amounts 8.05 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> service from <strong>the</strong> ASDW catalogue,<br />
toge<strong>the</strong>r with its cost calculation.<br />
Table 28.<br />
Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
<strong>CT</strong>: One or more parts<br />
<strong>of</strong> <strong>the</strong> body<br />
exam<strong>in</strong>ation - with<br />
contrast media<br />
5.03.00.0000029<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
<strong>CT</strong><br />
laboratory Oncologic<br />
dispensary<br />
37 5 8,05 7,54<br />
<strong>PET</strong>-<strong>CT</strong> is a <strong>in</strong>dividually contracted service <strong>of</strong> 420 po<strong>in</strong>ts <strong>in</strong> pric<strong>in</strong>g. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz, <strong>the</strong><br />
sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Test<br />
cost<br />
(PLN)<br />
335,55<br />
46
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 29.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
420 10,75<br />
Test cost [PLN]<br />
4 515,00<br />
The average <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> lung cancer amounts 335.55 PLN,<br />
and <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong> public payer’s perspective – amounts 4,515.00<br />
PLN.<br />
The follow<strong>in</strong>g table shows selected items, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services, used to<br />
calculate <strong>the</strong> costs <strong>of</strong> 4 or 6 cycles <strong>of</strong> palliative chemo<strong>the</strong>rapy.<br />
Table 30.<br />
<strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected chemo<strong>the</strong>rapy regimens from <strong>the</strong> NHF’s catalogue <strong>of</strong> services<br />
Type <strong>of</strong> <strong>the</strong><br />
<strong>the</strong>rapy<br />
PV<br />
KV<br />
PE<br />
PN<br />
KN<br />
PG<br />
KG<br />
Active substances Posology<br />
CIS-PLATINUM //<br />
VINBLASTINUM<br />
CARBOPLATINUM //<br />
VINBLASTINUM<br />
CIS-PLATINUM //<br />
ETOPOSIDUM<br />
VINORELBINUM // CIS-<br />
PLATINUM<br />
VINORELBINUM //<br />
CARBOPLATINUM<br />
GEMCITABINUM // CIS-<br />
PLATINUM<br />
GEMCITABINUM<br />
//CARBOPLATINUM<br />
100 mg/m 2 iv day 1 // 5 mg/m 2 iv<br />
days 1 and 8 every 21 days<br />
300-350 mg/m 2 iv day 1 // 5 mg/m 2<br />
iv days 1 and 8 every 21 days<br />
30 mg/m 2 /day 1–3 or 80–100<br />
mg/m 2 iv day 1 // 100–120<br />
mg/m 2 /days 1–3 every 21 days<br />
25-30 mg/m 2 iv day 1 and 8 // 80-<br />
100 mg/m 2 iv day 1 every 21 days<br />
25-30 mg/m 2 iv day 1 and 8 every<br />
21 days// 300-350 mg/m 2 iv day 1<br />
1,250 mg/m 2 iv days 1 and 8 // 100<br />
mg/m 2 iv day 2<br />
1,000 mg/m 2 iv day 1 and 8// 300<br />
mg/m 2 iv day 2 every 21 days<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure<br />
=No <strong>of</strong> po<strong>in</strong>ts x po<strong>in</strong>t<br />
price (10 PLN) [PLN]*<br />
403,72–605,58<br />
417,72–626,58<br />
210,72–316,08<br />
563,24–844,86<br />
577,24–865,86<br />
1 506,92–2 260,38<br />
1 294,28–1 941,42<br />
*<strong>Cost</strong> <strong>in</strong>tervals are presented accord<strong>in</strong>gly to <strong>the</strong> quantity <strong>of</strong> applied chemo<strong>the</strong>rapy cycles, 4 or 6 cycles<br />
Table 31 conta<strong>in</strong>s selected radio<strong>the</strong>rapeutic procedures, from <strong>the</strong> NHF’s catalogue <strong>of</strong><br />
services, used <strong>in</strong> lung cancer treatment, as well as its cost.<br />
47
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 31.<br />
<strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services<br />
Type <strong>of</strong> service<br />
Code <strong>of</strong> <strong>the</strong><br />
procedure<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure =No <strong>of</strong> po<strong>in</strong>ts<br />
x po<strong>in</strong>t price (10 PLN) [PLN]<br />
palliative teleradio<strong>the</strong>rapy 5.07.01.0000021 1 800<br />
radical teleradio<strong>the</strong>rapy with threedimensional<br />
(3D) plann<strong>in</strong>g<br />
5.07.01.0000023 8 000<br />
standard brachy<strong>the</strong>rapy 5.07.01.0000025 4 000<br />
3D brachy<strong>the</strong>rapy with real time plann<strong>in</strong>g 5.07.01.0000026 5 200<br />
The table below conta<strong>in</strong>s selected procedures, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services,<br />
<strong>in</strong>clud<strong>in</strong>g operative treatment <strong>of</strong> <strong>the</strong> lung cancer, as well as its cost.<br />
Table 32.<br />
Selected surgical procedures used <strong>in</strong> lung cancer treatment<br />
Name <strong>of</strong> <strong>the</strong> procedure Code <strong>of</strong> <strong>the</strong> procedure<br />
lungs/lung sleeve resection, pneumonectomy,<br />
sleeve lobectomy (anatomic resection with<br />
mediast<strong>in</strong>al lymphadenectomy)<br />
Lung resection – segmental lung resection,<br />
wedge lungs resection<br />
3.4. MODEL PARAMETERS<br />
Ma<strong>in</strong> model parameters are shown <strong>in</strong> <strong>the</strong> table below.<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure<br />
=No <strong>of</strong> po<strong>in</strong>ts x po<strong>in</strong>t price<br />
(10 PLN) [PLN]<br />
5.06.00.0000368 12 000<br />
5.06.00.0000170 8 000<br />
Table 33.<br />
Comparison <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong><br />
cl<strong>in</strong>ical advancement <strong>of</strong> non-small cell lung cancer diagnostics<br />
Parameter <strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> diagnostic procedure<br />
[PLN]<br />
<strong>Cost</strong> <strong>of</strong> surgical treatment (cChir)<br />
[PLN]<br />
<strong>Cost</strong> <strong>of</strong> comb<strong>in</strong>ed <strong>the</strong>rapy with<br />
chemo<strong>the</strong>rapy (cChir_Chem) [PLN]<br />
4 515,00 (1 313,00*) 335,55 (265,50; 414,00)<br />
12 000,00 (8 000,00**)<br />
22 603,80 (11 160,80; 34 603,80)<br />
48
<strong>Cost</strong> <strong>of</strong> chemo<strong>the</strong>rapy comb<strong>in</strong>ed with<br />
radio<strong>the</strong>rapy (cChem_RT) [PLN]<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
13 632,40 (3 907,20; 23 069,20)<br />
<strong>Cost</strong> <strong>of</strong> chemo<strong>the</strong>rapy (cChem) [PLN] 5 632,40 (2 107,20; 15 069,20)<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (I)<br />
(eP_Stadium1) [years]<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (I) treated<br />
<strong>in</strong>correctly (eP_Stadium1m<strong>in</strong>us)<br />
[years]<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (II)<br />
(eP_Stadium2) [years]<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (II)<br />
treated <strong>in</strong>correctly<br />
(eP_Stadium2m<strong>in</strong>us) [years]<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (IIIA)<br />
(eP_Stadium3A) [years]<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (IIIA)<br />
treated <strong>in</strong>correctly<br />
(eP_Stadium3Am<strong>in</strong>us) [years]<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (IIIA)<br />
treated <strong>in</strong>correctly – worse prognosis<br />
(eP_Stadium3A2m<strong>in</strong>us) [years]<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (IIIB)<br />
(eP_Stadium3B) [years]<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (IIIB)<br />
treated <strong>in</strong>correctly<br />
(eP_Stadium3Bm<strong>in</strong>us) [years]<br />
Survival <strong>of</strong> patients <strong>in</strong> stage (IV)<br />
(eP_Stadium4) [years]<br />
Probability <strong>of</strong> be<strong>in</strong>g classified, on a<br />
basis <strong>of</strong> <strong>the</strong> procedure, as a stage (I)<br />
Probability <strong>of</strong> be<strong>in</strong>g classified, on a<br />
basis <strong>of</strong> <strong>the</strong> procedure, as a stage (II)<br />
Probability <strong>of</strong> be<strong>in</strong>g classified, on a<br />
basis <strong>of</strong> <strong>the</strong> procedure, as a stage<br />
(IIIA)<br />
Probability <strong>of</strong> be<strong>in</strong>g classified, on a<br />
basis <strong>of</strong> <strong>the</strong> procedure, as a stage<br />
(IIIB)<br />
Probability <strong>of</strong> be<strong>in</strong>g classified, on a<br />
basis <strong>of</strong> <strong>the</strong> procedure, as a stage (IV)<br />
Probability <strong>of</strong> correct classification –<br />
stage (I)<br />
Probability <strong>of</strong> correct classification –<br />
stage (II)<br />
4,0 (3,3; 5,5)<br />
1,0 (0,5; 1,5)<br />
2,2 (1,7; 2,7)<br />
1,0 (0,45; 1,4)<br />
1,4 (1,0; 1,7)<br />
1,0 (0,8; 1,6)<br />
0,7 (0,5; 0,9)<br />
0,76 (0,7; 0,83)<br />
0,5 (0,3; 0,8)<br />
0,5 (0,2; 0,6)<br />
0,3272 (0,3060; 0,3484) 0,3170 (0,2959; 0,3380)<br />
0,1539 (0,1376; 0,1702) 0,1718 (0,1547; 0,1888)<br />
0,1894 (0,1717; 0,2071) 0,1856 (0,1680; 0,2032)<br />
0,1894 (0,1717; 0,2071) 0,1856 (0,1680; 0,2032)<br />
0,1401 (0,1244; 0,1558) 0,1401 (0,1244; 0,1558)<br />
0,8563 (0,8404; 0,8721) 0,8323 (0,8154; 0,8492)<br />
0,4784 (0,4558; 0,5010) 0,4643 (0,4417; 0,4868)<br />
49
Probability <strong>of</strong> correct classification –<br />
stage (IIIA)<br />
Probability <strong>of</strong> correct classification –<br />
stage (IIIB)<br />
Probability <strong>of</strong> correct classification –<br />
stage (IV)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (I) – stage (II)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (I) – stage (IIIA)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (I) – stage (IIIB)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (I) – stage (IV)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (II) – stage (I)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (II) – stage (IIIA)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (II) – stage (IIIB)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (II) – stage (IV)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IIIA) – stage (I)<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
0,5452 (0,5227; 0,5677) 0,4959 (0,4733; 0,5185)<br />
0,5452 (0,5227; 0,5677) 0,4959 (0,4385; 0,5532)<br />
0,3066 (0,2857; 0,3274) 0,2482 (0,2286; 0,2677)<br />
0,4022 (0,3800; 0,4243) 0,3269 (0,3057; 0,3481)<br />
0,2772 (0,2569; 0,2974) 0,2981 (0,2774; 0,3188)<br />
0,2772 (0,2569; 0,2974) 0,2981 (0,2774; 0,3188)<br />
0,0435 (0,0343; 0,0527) 0,0769 (0,0649; 0,0890)<br />
0,3389 (0,3175; 0,3603) 0,3274 (0,3062; 0,3486)<br />
0,4636 (0,4411; 0,4862) 0,4429 (0,4204; 0,4653)<br />
0,4636 (0,4411; 0,4862) 0,4429 (0,4204; 0,4653)<br />
0,0727 (0,0610; 0,0845) 0,1143 (0,0999; 0,1287)<br />
0,7338 (0,7138; 0,7538) 0,7639 (0,7447; 0,7831)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IIIA) – stage (II) 0,2662 (0,2462; 0,2862) 0,2361 (0,2169; 0,2553)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IIIA) – stage (IIIB)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IIIA) – stage (IV)<br />
Probability <strong>of</strong> overestimation –<br />
diagnosed stage (IIIA) – probable<br />
stages (I) or (II)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IIIB) – stage (I)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IIIB) – stage (II)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IIIB) – stage (IIIA)<br />
0,8644 (0,8489; 0,8799) 0,7949 (0,7766; 0,8131)<br />
0,1356 (0,1201; 0,1511) 0,2051 (0,1869; 0,2234)<br />
0,3752 (0,3533; 0,3971) 0,3967 (0,3746; 0,4188)<br />
0,6201 (0,5981; 0,6420) 0,6286 (0,6067; 0,6504)<br />
0,2249 (0,2060; 0,2438) 0,1943 (0,1764; 0,2122)<br />
0,1550 (0,1386; 0,1714) 0,1771 (0,1599; 0,1944)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IIIB) – stage (IV) 0,0108 (0,0061; 0,0155) 0,0220 (0,0154; 0,0287)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification 0,5368 (0,5143; 0,5594) 0,5340 (0,5114; 0,5565)<br />
50
as a stage (IV) – stage (I)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IV) – stage (II)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IV) – stage (IIIA)<br />
Probability <strong>of</strong> <strong>in</strong>correct classification<br />
as a stage (IV) – stage (IIIB)<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
0,1947 (0,1768; 0,2126) 0,1650 (0,1483; 0,1818)<br />
0,1342 (0,1188; 0,1496) 0,1505 (0,1343; 0,1667)<br />
0,1342 (0,1188; 0,1496) 0,1505 (0,1343; 0,1667)<br />
*“threshold” <strong>PET</strong>-<strong>CT</strong> cost at 7,700 procedures per year (estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report)<br />
**<strong>Cost</strong> <strong>of</strong> alternative surgical treatment (procedure No. 5.06.00.0000170 – see table 5)<br />
• <strong>PET</strong>-<strong>CT</strong> cost amounts 4,515.00 PLN (alternative <strong>PET</strong>-<strong>CT</strong> cost, amount<strong>in</strong>g 1,313.00 PLN<br />
was also assumed – cost estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report).<br />
• The average <strong>CT</strong> cost amounts 335.55; m<strong>in</strong>imal cost <strong>of</strong> this procedure amounted 265<br />
PLN, maximal – 414.00 PLN.<br />
• The average cost <strong>of</strong> lung cancer surgical treatment was assumed as equal to <strong>the</strong> cost<br />
<strong>of</strong> procedure No. 5.06.00.0000368 from <strong>the</strong> hospital services catalogue (alternative<br />
cost <strong>of</strong> surgical treatment was assumed as equal to <strong>the</strong> cost <strong>of</strong> procedure No.<br />
5.06.00.0000170 – see table 32).<br />
• The average cost <strong>of</strong> lung cancer surgical treatment with neoadiuvant and adiuvant<br />
chemo<strong>the</strong>rapy was assumed as equal to <strong>the</strong> cost <strong>of</strong> procedure No. 5.06.00.0000368<br />
from <strong>the</strong> hospital services catalogue (alternative cost <strong>of</strong> surgical treatment was<br />
assumed as equal to <strong>the</strong> cost <strong>of</strong> procedure No. 5.06.00.0000170 – see table 32) and<br />
<strong>the</strong> cost <strong>of</strong> 2 cycles <strong>of</strong> neoadiuvant and 4 cycles <strong>of</strong> adiuvant PN chemo<strong>the</strong>rapy from<br />
<strong>the</strong> oncologic services catalogue (range <strong>of</strong> costs between m<strong>in</strong>imal and maximal cost<br />
<strong>of</strong> non-small cell lung cancer chemo<strong>the</strong>rapy – see table 30).<br />
• The average cost <strong>of</strong> lung cancer radio<strong>the</strong>rapy with chemo<strong>the</strong>rapy was assumed as<br />
equal to <strong>the</strong> cost <strong>of</strong> procedure 5.07.01.0000023 from <strong>the</strong> catalogue <strong>of</strong> oncologic<br />
services (range <strong>of</strong> costs between m<strong>in</strong>imal and maximal cost <strong>of</strong> non-small cell lung<br />
cancer radio<strong>the</strong>rapy – see table 31) and <strong>the</strong> cost <strong>of</strong> 4 cycles <strong>of</strong> adiuvant PN<br />
chemo<strong>the</strong>rapy from <strong>the</strong> oncologic services catalogue (range <strong>of</strong> costs between<br />
m<strong>in</strong>imal and maximal cost <strong>of</strong> non-small cell lung cancer chemo<strong>the</strong>rapy – see table<br />
30).<br />
• As <strong>the</strong> average cost <strong>of</strong> chemo<strong>the</strong>rapy, <strong>the</strong> cost <strong>of</strong> 4 cycles PN chemo<strong>the</strong>rapy from<br />
<strong>the</strong> catalogue <strong>of</strong> oncologic services was assumed (range <strong>of</strong> costs between m<strong>in</strong>imal<br />
51
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
and maximal cost <strong>of</strong> chemo<strong>the</strong>rapy regimens used <strong>in</strong> non-small cell lung cancer<br />
treatment – see table 30).<br />
• Life expectancy <strong>in</strong> particular stages <strong>of</strong> <strong>the</strong> disease and <strong>the</strong>ir m<strong>in</strong>imal and maximal<br />
values were assumed on a basis <strong>of</strong> <strong>the</strong> literature or estimation <strong>of</strong> experts from <strong>the</strong><br />
Maria Skłodowska – Curie Memorial Institute, Center <strong>of</strong> Oncology <strong>in</strong> Warsaw.<br />
• Values <strong>of</strong> <strong>the</strong> rest <strong>of</strong> parameters were taken from <strong>the</strong> report: “Comparative cost –<br />
<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic<br />
technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics -<br />
epidemiological and cl<strong>in</strong>ical part”. Information from <strong>the</strong> follow<strong>in</strong>g publications were<br />
used:<br />
3.5. RESULTS<br />
o Cerfolio RJ, Bryant AS, Ojha B, Eloubeidi M. Improv<strong>in</strong>g <strong>the</strong> <strong>in</strong>accuracies <strong>of</strong><br />
cl<strong>in</strong>ical stag<strong>in</strong>g <strong>of</strong> patients with NSCLC: A prospective trial. Ann Thora Surg<br />
2005; Vol. 80 (4): pp 1207–1214.<br />
o Shim SS, Lee KS, Kim BT, Chung MJ, Lee EJ, Han J, Choi JY, Kwon OJ, Shim YM,<br />
Kim S. Non-small cell lung cancer: prospective comparison <strong>of</strong> <strong>in</strong>tegrated FDG<br />
<strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> alone for preoperative stag<strong>in</strong>g. Radiology 2005 Sep; 236 (3): pp<br />
1011–1019. Epub 2005 Jul 12.<br />
The follow<strong>in</strong>g table shows results <strong>of</strong> <strong>the</strong> comparative cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs<br />
computed tomography used <strong>in</strong> non-small cell lung cancer cl<strong>in</strong>ical advancement assessment,<br />
where <strong>the</strong> average life expectancy, expressed <strong>in</strong> years, was considered as <strong>the</strong> <strong>effect</strong>. Cohort<br />
simulation method was used <strong>in</strong> calculations.<br />
Table 34.<br />
Results <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> non-small cell lung cancer cl<strong>in</strong>ical advancement<br />
assessment<br />
Procedure<br />
<strong>Cost</strong> per one<br />
patient [PLN]<br />
<strong>Cost</strong> difference<br />
[PLN]<br />
Average<br />
lifetime<br />
expectancy<br />
[years]<br />
<strong>PET</strong>-<strong>CT</strong> 17 624,71 2,254<br />
<strong>CT</strong> 13 497,43<br />
4 127,28<br />
2,227<br />
Effects<br />
difference<br />
(LYG)<br />
ICER<br />
[PLN/LYG]<br />
0,027 152 862,22<br />
52
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> revealed, that diagnostics <strong>of</strong> non-small cell lung cancer cl<strong>in</strong>ical<br />
advancement us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more expensive than us<strong>in</strong>g computed tomography, but<br />
simultaneously gives a better long-term <strong>effect</strong>, measured with life years ga<strong>in</strong>ed ratio. <strong>Cost</strong>s <strong>of</strong><br />
<strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> <strong>in</strong>cluded costs <strong>of</strong> <strong>the</strong> diagnostic procedure, surgical treatment and costs <strong>of</strong><br />
palliative chemo<strong>the</strong>rapy. The cost difference between diagnostic procedures amounts<br />
4,127.28 PLN per one patient. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong> one patient allows to ga<strong>in</strong> 2.254 life years. In a<br />
group <strong>of</strong> patients, where computed tomography was performed, <strong>the</strong> anticipated health<br />
<strong>effect</strong> amounts 2.227 life years. Difference <strong>of</strong> <strong>effect</strong>s between <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> amounts 0.027<br />
LYG (life years ga<strong>in</strong>ed) i.e. approx. 10 days.<br />
Diagnostics <strong>of</strong> non-small cell lung cancer cl<strong>in</strong>ical advancement, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>system</strong> is more<br />
expensive, but more <strong>effect</strong>ive than computed tomography diagnostics. Incremental cost-<br />
<strong>effect</strong>iveness ratio amounts 152,862.22 PLN/LYG, that means, ga<strong>in</strong><strong>in</strong>g one additional year <strong>of</strong><br />
life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, costs 152,862.22 PLN.<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> was also performed us<strong>in</strong>g Monte Carlo simulation method for<br />
100,000 patients. Results are shown <strong>in</strong> table 35.<br />
Table 35.<br />
Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong><br />
non-small cell lung cancer cl<strong>in</strong>ical advancement<br />
Parameter<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> [PLN] Effect [years] <strong>Cost</strong> [PLN] Effect [years]<br />
ICER<br />
[PLN/LYG]<br />
Average 17 611,12 2,256 13 488,59 2,228 147 233,21<br />
Standard deviation 3 711,41 1,444 3 742,35 1,444<br />
M<strong>in</strong>imal value 10 147,40 0,500 5 967,95 0,500<br />
Median 16 515,00 1,400 12 335,55 1,400<br />
Maximal value 22 147,40 4,000 17 967,95 4,000<br />
Results obta<strong>in</strong>ed us<strong>in</strong>g <strong>the</strong> Monte Carlo method do not differ from results obta<strong>in</strong>ed <strong>in</strong> <strong>the</strong><br />
cohort simulation method. Assessment <strong>of</strong> non-small cell lung cancer cl<strong>in</strong>ical advancement<br />
us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> method rema<strong>in</strong>s more expensive and more <strong>effect</strong>ive than us<strong>in</strong>g computed<br />
tomography only. Difference <strong>of</strong> <strong>effect</strong>s averages amounts 0.028 <strong>of</strong> a life year. Median <strong>of</strong> <strong>the</strong><br />
<strong>effect</strong> <strong>in</strong> a group <strong>of</strong> patients diagnosed us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> amount 1.4 life years.<br />
Incremental cost-<strong>effect</strong>iveness ratio amounts 147,233.21 PLN/LYG that means, ga<strong>in</strong><strong>in</strong>g one<br />
-<br />
53
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
additional year <strong>of</strong> life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>of</strong> non-small cell lung cancer cl<strong>in</strong>ical<br />
advancement assessment, <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, costs 147,233.21 PLN.<br />
3.6. SENSITIVITY ANALYSIS<br />
One-way sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong> non-small cell lung cancer<br />
cl<strong>in</strong>ical assessment, was conducted for various model parameters:<br />
• assumption <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> cost on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN (“subthreshold” <strong>PET</strong>-<strong>CT</strong> cost at<br />
7,700 procedures per year, estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong><br />
<strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report);<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> <strong>CT</strong>;<br />
• assumption <strong>of</strong> <strong>the</strong> alternative cost <strong>of</strong> <strong>the</strong> surgical treatment amount<strong>in</strong>g 8,000.00 PLN;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> surgical treatment comb<strong>in</strong>ed with chemo<strong>the</strong>rapy;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> chemo<strong>the</strong>rapy;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> surgical treatment comb<strong>in</strong>ed with radio<strong>the</strong>rapy;<br />
• m<strong>in</strong>imal and maximal life expectancy <strong>of</strong> patients with stage (I), (II), (IIIA), (IIIB) and (IV)<br />
<strong>of</strong> <strong>the</strong> disease;<br />
• m<strong>in</strong>imal and maximal life expectancy <strong>of</strong> patients with stage (I), (II), (IIIA), (IIIB) <strong>of</strong> <strong>the</strong><br />
disease <strong>in</strong> a group <strong>of</strong> <strong>in</strong>correctly treated patients;<br />
• m<strong>in</strong>imal and maximal life expectancy <strong>of</strong> patients with stage (IIIA) <strong>of</strong> <strong>the</strong> disease <strong>in</strong> a<br />
group <strong>of</strong> <strong>in</strong>correctly treated patients with worse prognosis.<br />
Two-way sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong> non-small cell lung cancer<br />
cl<strong>in</strong>ical assessment, was conducted for various model parameters:<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> classification us<strong>in</strong>g <strong>the</strong> procedure as stage (I),<br />
(II), (IIIA), (IIIB), (IV);<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> correct classification as stage (I), (II), (IIIA), (IIIB),<br />
(IV);<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> <strong>in</strong>correct classification as a stage (I) <strong>in</strong> stage (II),<br />
(IIIA), (IV);<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> <strong>in</strong>correct classification as a stage (II) <strong>in</strong> stage (I);<br />
• m<strong>in</strong>imal probabilities <strong>of</strong> <strong>in</strong>correct classification as a stage (II) <strong>in</strong> stage (IIIA);<br />
54
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• maximal probabilities <strong>of</strong> <strong>in</strong>correct classification as a stage (IIIA) <strong>in</strong> stage (I);<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> <strong>in</strong>correct classification as a stage (IV) <strong>in</strong> stage (I).<br />
Sensitivity <strong>analysis</strong> results for <strong>the</strong> variable model parameters are shown <strong>in</strong> table below.<br />
Table 36.<br />
Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> comparison <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> non-small cell lung cancer cl<strong>in</strong>ical advancement<br />
assessment<br />
Parameter<br />
<strong>Cost</strong> [PLN]<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
Effect<br />
[years]<br />
<strong>Cost</strong> [PLN]<br />
Effect<br />
[years]<br />
ICER<br />
[PLN/LYG]<br />
Basel<strong>in</strong>e state 17 624,71 2,254 13 497,43 2,227 152 862,22<br />
Alternative <strong>PET</strong>-<strong>CT</strong> cost 14 422,71 2,254 13 497,43 2,227 34 269,63<br />
M<strong>in</strong>imal cost <strong>of</strong> <strong>CT</strong> 17 624,71 2,254 13 427,38 2,227 155 456,67<br />
Maximal cost <strong>of</strong> <strong>CT</strong> 17 624,71 2,254 13 575,88 2,227 149 956,67<br />
Alternative cost <strong>of</strong> surgical<br />
treatment<br />
M<strong>in</strong>imal cost <strong>of</strong> surgical treatment<br />
comb<strong>in</strong>ed with chemo<strong>the</strong>rapy<br />
Maximal cost <strong>of</strong> surgical treatment<br />
comb<strong>in</strong>ed with chemo<strong>the</strong>rapy<br />
15 700,31 2,254 11 542,23 2,227 154 002,96<br />
16 055,00 2,254 11 959,21 2,227 151 695,93<br />
18 790,51 2,254 14 639,83 2,227 153 728,89<br />
M<strong>in</strong>imal cost <strong>of</strong> chemo<strong>the</strong>rapy 16 932,63 2,254 12 751,25 2,227 154 865,93<br />
Maximal cost <strong>of</strong> chemo<strong>the</strong>rapy 19 477,39 2,254 15 494,90 2,227 147 499,63<br />
M<strong>in</strong>imal cost <strong>of</strong> chemo<strong>the</strong>rapy<br />
comb<strong>in</strong>ed with radio<strong>the</strong>rapy<br />
Maximal cost <strong>of</strong> chemo<strong>the</strong>rapy<br />
comb<strong>in</strong>ed with radio<strong>the</strong>rapy<br />
M<strong>in</strong>imal survival <strong>of</strong> patients <strong>in</strong> stage<br />
(I)<br />
Maximal survival <strong>of</strong> patients <strong>in</strong><br />
stage (I)<br />
M<strong>in</strong>imal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (I)<br />
Maximal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (I)<br />
15 249,37 2,254 11 171,00 2,227 151 050,74<br />
18 878,65 2,254 14 725,55 2,227 153 818,52<br />
17 624,71 1,985 13 497,43 1,963 187 603,64<br />
17 624,71 2,831 13 497,43 2,791 103 182,00<br />
17 624,71 2,202 13 497,43 2,171 133 138,06<br />
17 624,71 2,307 13 497,43 2,283 171 970,00<br />
M<strong>in</strong>imal survival <strong>of</strong> patients <strong>in</strong> stage<br />
(II) 17 624,71 2,199 13 497,43 2,169 137 576,00<br />
Maximal survival <strong>of</strong> patients <strong>in</strong><br />
stage (II)<br />
17 624,71 2,310 13 497,43 2,284 158 741,54<br />
55
M<strong>in</strong>imal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (II)<br />
Maximal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (II)<br />
M<strong>in</strong>imal survival <strong>of</strong> patients <strong>in</strong> stage<br />
(IIIA)<br />
Maximal survival <strong>of</strong> patients <strong>in</strong><br />
stage (IIIA)<br />
M<strong>in</strong>imal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (IIIA)<br />
Maximal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (IIIA)<br />
M<strong>in</strong>imal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (IIIA) –<br />
worse prognosis<br />
Maximal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (IIIA) –<br />
worse prognosis<br />
M<strong>in</strong>imal survival <strong>of</strong> patients <strong>in</strong> stage<br />
(IIIB)<br />
Maximal survival <strong>of</strong> patients <strong>in</strong><br />
stage (IIIB)<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
17 624,71 2,234 13 497,43 2,208 158 741,54<br />
17 624,71 2,270 13 497,43 2,241 142 320,00<br />
17 624,71 2,213 13 497,43 2,190 179 446,96<br />
17 624,71 2,285 13 497,43 2,254 133 138,06<br />
17 624,71 2,249 13 497,43 2,220 142 320,00<br />
17 624,71 2,275 13 497,43 2,252 179 446,96<br />
17 624,71 2,249 13 497,43 2,220 142 320,00<br />
17 624,71 2,260 13 497,43 2,233 152 862,22<br />
17 624,71 2,246 13 497,43 2,218 147 402,86<br />
17 624,71 2,264 13 497,43 2,237 152 862,22<br />
M<strong>in</strong>imal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (IIIB) 17 624,71 2,252 13 497,43 2,224 147 402,86<br />
Maximal survival <strong>of</strong> <strong>in</strong>correctly<br />
treated patients <strong>in</strong> stage (IIIB)<br />
M<strong>in</strong>imal survival <strong>of</strong> patients <strong>in</strong> stage<br />
(IV)<br />
Maximal survival <strong>of</strong> patients <strong>in</strong><br />
stage (IV)<br />
M<strong>in</strong>imal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (I)<br />
Maximal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (I)<br />
M<strong>in</strong>imal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (II)<br />
Maximal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (II)<br />
M<strong>in</strong>imal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (IIIA)<br />
17 624,71 2,258 13 497,43 2,232 158 741,54<br />
17 624,71 2,239 13 497,43 2,211 147 402,86<br />
17 624,71 2,260 13 497,43 2,232 147 402,86<br />
17 708,76 2,195 13 577,88 2,170 165 235,20<br />
17 540,66 2,313 13 417,36 2,283 137 443,33<br />
17 680,45 2,226 13 553,44 2,198 147 393,21<br />
17 568,97 2,282 13 441,75 2,255 152 860,00<br />
17 624,71 2,231 13 497,43 2,203 147 402,86<br />
56
Maximal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (IIIA)<br />
M<strong>in</strong>imal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (IIIB)<br />
Maximal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (IIIB)<br />
M<strong>in</strong>imal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (IV)<br />
Maximal probability <strong>of</strong> be<strong>in</strong>g<br />
classified, on a basis <strong>of</strong> <strong>the</strong><br />
procedure, as a stage (IV)<br />
M<strong>in</strong>imal probability <strong>of</strong> correct<br />
classification – stage (I)<br />
Maximal probability <strong>of</strong> correct<br />
classification – stage (I)<br />
M<strong>in</strong>imal probability <strong>of</strong> correct<br />
classification – stage (II)<br />
Maximal probability <strong>of</strong> correct<br />
classification – stage (II)<br />
M<strong>in</strong>imal probability <strong>of</strong> correct<br />
classification – stage (IIIA)<br />
Maximal probability <strong>of</strong> correct<br />
classification – stage (IIIA)<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
17 624,71 2,277 13 497,43 2,250 152 862,22<br />
17 624,71 2,254 13 497,43 2,227 152 862,22<br />
17 624,71 2,254 13 497,43 2,227 152 862,22<br />
17 794,53 2,256 13 667,24 2,228 147 403,21<br />
17 454,90 2,253 13 327,61 2,226 152 862,59<br />
17 649,72 2,235 13 526,51 2,206 142 179,66<br />
17 599,81 2,274 13 468,46 2,248 158 898,08<br />
17 675,42 2,242 13 553,94 2,213 142 120,00<br />
17 574,00 2,266 13 440,92 2,240 158 964,62<br />
17 624,71 2,247 13 497,43 2,219 147 402,86<br />
17 624,71 2,262 13 497,43 2,234 147 402,86<br />
M<strong>in</strong>imal probability <strong>of</strong> correct<br />
classification – stage (IIIB) 17 624,71 2,256 13 497,43 2,229 152 862,22<br />
Maximal probability <strong>of</strong> correct<br />
classification – stage (IIIB)<br />
M<strong>in</strong>imal probability <strong>of</strong> correct<br />
classification – stage (IV)<br />
Maximal probability <strong>of</strong> correct<br />
classification – stage (IV)<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (I) – stage<br />
(II)<br />
Maximal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (I) – stage<br />
(II)<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (I) – stage<br />
(IIIA)<br />
Maximal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (I) – stage<br />
17 624,71 2,252 13 497,43 2,225 152 862,22<br />
17 624,71 2,259 13 497,43 2,231 147 402,86<br />
17 624,71 2,249 13 497,43 2,222 152 862,22<br />
17 630,59 2,253 13 503,78 2,225 147 386,07<br />
17 618,86 2,256 13 491,08 2,228 147 420,71<br />
17 624,71 2,254 13 497,43 2,226 147 402,86<br />
17 624,71 2,255 13 497,43 2,227 147 402,86<br />
57
(IIIA)<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (I) – stage<br />
(IV)<br />
Maximal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (I) – stage<br />
(IV)<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (II) – stage<br />
(I)<br />
Maximal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (II) – stage<br />
(I)<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (II) – stage<br />
(IIIA)<br />
Maximal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (IIIA) –<br />
stage (I)<br />
M<strong>in</strong>imal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (IV) – stage<br />
(I)<br />
Maximal probability <strong>of</strong> <strong>in</strong>correct<br />
classification as a stage (IV) – stage<br />
(I)<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
17 624,71 2,255 13 497,43 2,227 147 402,86<br />
17 624,71 2,254 13 497,43 2,227 152 862,22<br />
17 643,26 2,244 13 517,94 2,215 142 252,41<br />
17 606,16 2,265 13 476,91 2,238 152 935,19<br />
17 624,71 2,254 13 497,43 2,227 152 862,22<br />
17 624,71 2,257 13 497,43 2,229 147 402,86<br />
17 624,71 2,253 13 497,43 2,226 152 862,22<br />
17 624,71 2,256 13 497,43 2,228 147 402,86<br />
Generally, <strong>the</strong> sensitivity <strong>analysis</strong> did not reveal any sudden costs and <strong>effect</strong>s changes, for<br />
<strong>the</strong> mentioned parameters alterations, characteriz<strong>in</strong>g compared diagnostic schemes. Non-<br />
small cell lung cancer cl<strong>in</strong>ical advancement assessment, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>, rema<strong>in</strong>s more<br />
expensive, but simultaneously more <strong>effect</strong>ive than computed tomography diagnostics. The<br />
lowest ICER value was observed <strong>in</strong> case <strong>of</strong> assumption <strong>the</strong> alternative cost <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
procedure on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN (decrease <strong>of</strong> 77.58% from <strong>the</strong> basel<strong>in</strong>e value).<br />
Maximal ICER ratio value was observed <strong>in</strong> case <strong>of</strong> assum<strong>in</strong>g <strong>the</strong> m<strong>in</strong>imal life expectancy <strong>of</strong><br />
patient <strong>in</strong> stage (I) <strong>of</strong> <strong>the</strong> disease (ICER <strong>in</strong>crease <strong>of</strong> 22.73% from <strong>the</strong> basel<strong>in</strong>e value).<br />
3.7. LITERATURE<br />
1. Cerfolio RJ, Bryant AS, Ojha B, Eloubeidi M. Improv<strong>in</strong>g <strong>the</strong> <strong>in</strong>accuracies <strong>of</strong> cl<strong>in</strong>ical stag<strong>in</strong>g <strong>of</strong> patients<br />
with NSCLC: A prospective trial. Ann Thora Surg 2005; Vol. 80 (4): pp 1207–1214.<br />
2. Shim SS, Lee KS, Kim BT, Chung MJ, Lee EJ, Han J, Choi JY, Kwon OJ, Shim YM, Kim S. Non-small cell<br />
lung cancer: prospective comparison <strong>of</strong> <strong>in</strong>tegrated FDG <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> alone for preoperative<br />
stag<strong>in</strong>g. Radiology 2005 Sep; 236 (3): pp 1011–1019. Epub 2005 Jul 12.<br />
58
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
3. The Surveillance, Epidemiology, and End Results (SEER) Program <strong>of</strong> <strong>the</strong> National Cancer Institute<br />
(NCI) [http://seer.cancer.gov].<br />
4. Jahan TM, Glassberg AB, Cornett P, Haas-Kogan D, Anastassiou P, Selim S, Jablons D. Non-Small Cell<br />
Lung Cancer. Cancer Supportive Care [http://www.cancersupportivecare.com/nonsmallcell.html].<br />
5. Szczeklik A. Choroby wewnętrzne. Medycyna Praktyczna, Kraków 2006.<br />
59
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
4. GASTROINTESTINAL STROMAL TUMORS (GIST) – COST-<br />
EFFE<strong>CT</strong>IVENESS ANALYSIS –<strong>PET</strong>-<strong>CT</strong> VS <strong>CT</strong> DIAGNOSTICS<br />
In <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> compar<strong>in</strong>g assessment <strong>of</strong> response to imat<strong>in</strong>ib treatment <strong>in</strong><br />
patients with gastro<strong>in</strong>test<strong>in</strong>al stromal tumors (GIST) us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong>, a decision model was<br />
used, concern<strong>in</strong>g <strong>the</strong> assessment <strong>of</strong> patients treated with imat<strong>in</strong>ib due to <strong>the</strong> GIST, aim<strong>in</strong>g to<br />
early detection <strong>of</strong> possible recurrences and to modify planned treatment.<br />
The efficacy <strong>of</strong> <strong>the</strong> compared diagnostic methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical part <strong>of</strong> <strong>the</strong><br />
report, entitled “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<br />
<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic<br />
diagnostics - epidemiological and cl<strong>in</strong>ical part”. Cl<strong>in</strong>ical <strong>effect</strong>s were estimated on a basis <strong>of</strong><br />
available data from studies or experts’ estimations. <strong>Cost</strong>s, from <strong>the</strong> Polish public payer’s<br />
perspective were assumed on a basis <strong>of</strong> <strong>the</strong> available data concern<strong>in</strong>g procedures used <strong>in</strong><br />
GIST treatment, <strong>in</strong> a time horizon equal to patients’ life expectancy.<br />
4.1. MODEL DESCRIPTION<br />
Model used <strong>in</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> concerns a group <strong>of</strong> patients with<br />
gastro<strong>in</strong>test<strong>in</strong>al stromal tumor (GIST), qualified, on a basis <strong>of</strong> <strong>the</strong> prelim<strong>in</strong>ary cl<strong>in</strong>ical<br />
assessment, to <strong>the</strong> imat<strong>in</strong>ib treatment and disqualified from <strong>the</strong> surgical procedure. <strong>PET</strong>-<strong>CT</strong><br />
and <strong>CT</strong> diagnostics <strong>effect</strong>s and costs were compared. Decision model, us<strong>in</strong>g a TreeAge ®<br />
2004 (version 7) s<strong>of</strong>tware, was used <strong>in</strong> <strong>the</strong> <strong>analysis</strong>. Time horizon was estimated until patient’s<br />
death, cost data were estimated from <strong>the</strong> public payer’s perspective, on a basis <strong>of</strong> available<br />
<strong>in</strong>formation. The efficacy <strong>of</strong> <strong>the</strong> compared diagnostic methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical<br />
part <strong>of</strong> <strong>the</strong> report, entitled “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission<br />
tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong><br />
<strong>the</strong> oncologic diagnostics - epidemiological and cl<strong>in</strong>ical part”. Data concern<strong>in</strong>g <strong>the</strong><br />
treatment <strong>effect</strong>s and consequences <strong>of</strong> <strong>the</strong> improper treatment, result<strong>in</strong>g from <strong>the</strong><br />
misdiagnos<strong>in</strong>g, were obta<strong>in</strong>ed from <strong>the</strong> literature or from experts' estimation, <strong>in</strong> case <strong>of</strong><br />
unavailable data.<br />
Information concern<strong>in</strong>g <strong>effect</strong>iveness <strong>of</strong> <strong>the</strong> diagnostic test to obta<strong>in</strong> correct estimation <strong>of</strong><br />
<strong>the</strong> patient as well as data concern<strong>in</strong>g diagnostic errors were <strong>in</strong>corporated <strong>in</strong>to <strong>the</strong> model.<br />
Improper diagnostics may cause health or f<strong>in</strong>ancial losses.<br />
60
4.2. MODEL’S TRANSIENT STATES<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Decision model conta<strong>in</strong>s <strong>the</strong> follow<strong>in</strong>g transient states (equal for both variants <strong>of</strong> <strong>the</strong><br />
diagnostic procedure):<br />
• “GIST" is a basel<strong>in</strong>e state, characteriz<strong>in</strong>g population <strong>of</strong> patients with gastro<strong>in</strong>test<strong>in</strong>al<br />
stromal tumor treated with imat<strong>in</strong>ib. After <strong>the</strong> diagnostic procedure, <strong>the</strong>re is a<br />
possibility to pass <strong>in</strong>to <strong>the</strong> follow<strong>in</strong>g states:<br />
o Diagnosis: response to treatment (if <strong>the</strong> diagnostic procedure revealed<br />
response to imat<strong>in</strong>ib treatment <strong>in</strong> patients with GIST);<br />
o Diagnosis: progression (if <strong>the</strong> diagnostic procedure revealed a disease<br />
progression <strong>in</strong> patients with GIST treated with imat<strong>in</strong>ib).<br />
• “Diagnosis: response to treatment” – conta<strong>in</strong>s patients with GIST who, on a basis <strong>of</strong><br />
imag<strong>in</strong>g procedures, responded to imat<strong>in</strong>ib treatment. Patient diagnosed as a<br />
responder to treatment may pass to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Response to treatment (if <strong>the</strong>re is a response to imat<strong>in</strong>ib treatment);<br />
o Progression (if <strong>the</strong>re is a progression <strong>of</strong> <strong>the</strong> disease after imat<strong>in</strong>ib treatment).<br />
• “Diagnosis: progression” – conta<strong>in</strong>s patients with diagnosed progression <strong>of</strong> <strong>the</strong><br />
gastro<strong>in</strong>test<strong>in</strong>al stromal tumor. Patient with a diagnosed progression may pass to <strong>the</strong><br />
follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Response to treatment (if <strong>the</strong>re is a response to imat<strong>in</strong>ib treatment);<br />
o Progression (if <strong>the</strong>re is a progression <strong>of</strong> <strong>the</strong> disease after imat<strong>in</strong>ib treatment).<br />
The follow<strong>in</strong>g figure shows <strong>the</strong> illustration <strong>of</strong> <strong>the</strong> decision tree <strong>of</strong> <strong>the</strong> model, describ<strong>in</strong>g <strong>the</strong><br />
course <strong>of</strong> treatment patients with a gastro<strong>in</strong>test<strong>in</strong>al stromal tumor (GIST) who had a response<br />
to imat<strong>in</strong>ib treatment assessed us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> or computed tomography.<br />
61
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Figure 5.<br />
Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> <strong>the</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison, used to assess <strong>the</strong> response for<br />
imat<strong>in</strong>ib treatment <strong>of</strong> GIST (legend – table 40)<br />
As presented <strong>in</strong> <strong>the</strong> figure 5, it is assumed that all patients had imat<strong>in</strong>ib treatment.<br />
4.3. COSTS CALCULATION<br />
In a study concern<strong>in</strong>g <strong>the</strong> gastro<strong>in</strong>test<strong>in</strong>al stromal tumor diagnostics, <strong>the</strong> hybrid <strong>PET</strong>-<strong>CT</strong> was<br />
compared to <strong>the</strong> computed tomography (<strong>CT</strong>). Computed tomography is and out-patient<br />
diagnostic service, co-f<strong>in</strong>anced (ASDW), that amounts 42 po<strong>in</strong>ts – 37 po<strong>in</strong>ts are refunded by<br />
<strong>the</strong> National Health Fund and <strong>the</strong> 5 po<strong>in</strong>ts are covered by a physician referr<strong>in</strong>g to <strong>the</strong><br />
procedure (“Catalogue <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced out-patient diagnostic procedures ranges<br />
(ASDW)”. Annex No. 1b to <strong>the</strong> <strong>in</strong>formational materials AOS). Referrer covers <strong>the</strong> cost <strong>of</strong><br />
performed procedure, accord<strong>in</strong>g to <strong>the</strong> negotiated price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t. The National Health<br />
Fund covers <strong>the</strong> cost <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced diagnostic procedure, accord<strong>in</strong>gly to <strong>the</strong> prices <strong>of</strong><br />
<strong>the</strong> po<strong>in</strong>t, negotiated by: health care provider perform<strong>in</strong>g <strong>the</strong> procedure and by <strong>the</strong> referrer.<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on<br />
<strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories hav<strong>in</strong>g <strong>the</strong> contract<br />
with <strong>the</strong> National Health Fund <strong>in</strong> Poland, amounts 8.05 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> service from <strong>the</strong> ASDW catalogue,<br />
toge<strong>the</strong>r with its cost calculation.<br />
62
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 37.<br />
Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
<strong>CT</strong>: One or more parts<br />
<strong>of</strong> <strong>the</strong> body<br />
exam<strong>in</strong>ation - with<br />
contrast media<br />
5.03.00.0000029<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
<strong>CT</strong><br />
laboratory Oncologic<br />
dispensary<br />
37 5 8,05 7,54<br />
<strong>PET</strong>-<strong>CT</strong> is a <strong>in</strong>dividually contracted service <strong>of</strong> 420 po<strong>in</strong>ts <strong>in</strong> pric<strong>in</strong>g. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz, <strong>the</strong><br />
sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Table 38.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
Test<br />
cost<br />
(PLN)<br />
335,55<br />
Test cost [PLN]<br />
420 10,75 4 515,00<br />
The average <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> gastro<strong>in</strong>test<strong>in</strong>al stromal tumor<br />
(GIST) amounts 335.55 PLN, and <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong> public payer’s<br />
perspective – amounts 4,515.00 PLN.<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> imat<strong>in</strong>ib treatment <strong>of</strong> gastro<strong>in</strong>test<strong>in</strong>al stromal tumor was calculated on a basis <strong>of</strong><br />
<strong>the</strong> “Catalogue <strong>of</strong> <strong>the</strong>rapeutic programs” (Annex 1d to <strong>the</strong> Fund President’s resolution No<br />
12/2006 and annex No 9 to <strong>the</strong> resolution No 93/2005 worded as specified <strong>in</strong> annex No 5 to<br />
<strong>the</strong> Fund President’s resolution No 12/2006). <strong>Cost</strong> <strong>of</strong> imat<strong>in</strong>ib is presented <strong>in</strong> <strong>the</strong> follow<strong>in</strong>g<br />
table.<br />
Table 39.<br />
Active substance used <strong>in</strong> GIST treatment and its po<strong>in</strong>t value on a basis <strong>of</strong> <strong>the</strong> <strong>the</strong>rapeutic programs catalogue<br />
Name <strong>of</strong> <strong>the</strong> procedure Code <strong>of</strong> <strong>the</strong> procedure<br />
<strong>Cost</strong> <strong>of</strong> imat<strong>in</strong>ib = po<strong>in</strong>ts<br />
valuation x po<strong>in</strong>t price (10<br />
PLN) [PLN]<br />
63
IMATINIB<br />
CAPS. 0.1 G<br />
4.4. MODEL PARAMETERS<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Ma<strong>in</strong> model parameters are shown <strong>in</strong> <strong>the</strong> table below.<br />
5.08.04.0000036 77,50<br />
Table 40.<br />
Comparison <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong><br />
assessment <strong>of</strong> GIST response to imat<strong>in</strong>ib treatment<br />
Parameter <strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> diagnostic procedure<br />
[PLN] 4 515,00 (1 313,00*) 335,55 (174,50; 274,00)<br />
<strong>Cost</strong> <strong>of</strong> treatment patient respond<strong>in</strong>g<br />
to <strong>the</strong> <strong>the</strong>rapy (cChem_R) [PLN]<br />
<strong>Cost</strong> <strong>of</strong> treatment patient with<br />
progression (cChem_PD) [PLN]<br />
Survival <strong>of</strong> patients respond<strong>in</strong>g to<br />
treatment (eP_R) [years]<br />
Survival <strong>in</strong> case <strong>of</strong> wrong diagnosis<br />
(eP_Rm<strong>in</strong>us) [years]<br />
Survival <strong>of</strong> patients with progression<br />
(eP_PD) [years]<br />
Probability <strong>of</strong> obta<strong>in</strong><strong>in</strong>g test result<br />
ascerta<strong>in</strong><strong>in</strong>g response to treatment<br />
Probability <strong>of</strong> obta<strong>in</strong><strong>in</strong>g <strong>the</strong> correct<br />
result ascerta<strong>in</strong><strong>in</strong>g response to<br />
treatment<br />
Probability <strong>of</strong> obta<strong>in</strong><strong>in</strong>g correct result<br />
ascerta<strong>in</strong><strong>in</strong>g disease progression<br />
193 130,00 (132 432,00; 331 080,00)<br />
27 590,00 (22 072,00; 55 180,00)<br />
1,75 (1,2; 3,0)<br />
0,5 (0,3; 1,0)<br />
0,25 (0,2; 0,25)<br />
0,8500 (0,7702; 0,9298) 0,4500 (0,3388; 0,5612)<br />
0,9412 (0,8886; 0,9938) 0,7778 (0,6848; 0,8707)<br />
1** 0,1818 (0,0956; 0,2681)<br />
*“threshold” <strong>PET</strong>-<strong>CT</strong> cost at 7,700 procedures per year (estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report)<br />
**It was assumed that <strong>the</strong> result will always be correct if <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> reveals presence <strong>of</strong> <strong>the</strong> lesion.<br />
• <strong>PET</strong>-<strong>CT</strong> cost amounts 4,515.00 PLN (alternative <strong>PET</strong>-<strong>CT</strong> cost, amount<strong>in</strong>g 1,313.00 PLN<br />
was also assumed – cost estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report).<br />
• The average <strong>CT</strong> cost amounts 335.55; m<strong>in</strong>imal cost <strong>of</strong> this procedure amounted 265.50<br />
PLN, maximal – 414.00 PLN.<br />
64
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• The average cost <strong>of</strong> treat<strong>in</strong>g patient respond<strong>in</strong>g to <strong>the</strong> <strong>the</strong>rapy was equal to <strong>the</strong> cost<br />
<strong>of</strong> treatment with 400 mg imat<strong>in</strong>ib per day, until progression – for 17 months (treatment<br />
timeframe equal to <strong>the</strong> survival timeframes m<strong>in</strong>us three months) (cChem_R).<br />
• The average cost <strong>of</strong> treat<strong>in</strong>g patient with a progression was equal to <strong>the</strong> cost <strong>of</strong><br />
treatment with 400 mg imat<strong>in</strong>ib per day, until death – for 6 months (upper and lower<br />
<strong>in</strong>terval, equal to <strong>the</strong> survival <strong>in</strong>tervals) (cChem_PD).<br />
• Life expectancy <strong>in</strong> patients respond<strong>in</strong>g to <strong>the</strong>rapy, with progression or with response<br />
to <strong>the</strong>rapy <strong>in</strong> case <strong>of</strong> wrong diagnosis and its m<strong>in</strong>imal and maximal values were<br />
implemented on a basis <strong>of</strong> <strong>the</strong> literature and op<strong>in</strong>ion <strong>of</strong> experts from <strong>the</strong> Maria<br />
Skłodowska – Curie Memorial Institute, Center <strong>of</strong> Oncology <strong>in</strong> Warsaw.<br />
• Values <strong>of</strong> <strong>the</strong> parameters concern<strong>in</strong>g tests accuracy were taken from <strong>the</strong> report<br />
entitled “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<br />
<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong><br />
oncologic diagnostics - epidemiological and cl<strong>in</strong>ical part”. Information from <strong>the</strong><br />
follow<strong>in</strong>g publications were used:<br />
4.5. RESULTS<br />
o Antoch G, Kanja J, Bauer S, Kuehl H, Renz<strong>in</strong>g-Koehler K, Schuette J, Bockisch A,<br />
Debat<strong>in</strong> JF, Freudenberg LS. Comparison <strong>of</strong> <strong>PET</strong>, <strong>CT</strong>, and dual-modality <strong>PET</strong>-<strong>CT</strong><br />
imag<strong>in</strong>g for monitor<strong>in</strong>g <strong>of</strong> imat<strong>in</strong>ib (STI571) <strong>the</strong>rapy <strong>in</strong> patients with<br />
gastro<strong>in</strong>test<strong>in</strong>al stromal tumors. J Nucl Med 2004 Mar; 45 (3): pp 357–365.<br />
The follow<strong>in</strong>g table shows results <strong>of</strong> <strong>the</strong> comparative cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs<br />
computed tomography used <strong>in</strong> assessment <strong>the</strong> response for gastro<strong>in</strong>test<strong>in</strong>al stromal tumor,<br />
where <strong>the</strong> average lifetime expectancy expressed <strong>in</strong> years, was considered as <strong>the</strong> <strong>effect</strong>.<br />
Cohort simulation method was used <strong>in</strong> calculations.<br />
Table 41.<br />
List <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> results concern<strong>in</strong>g comparison <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> assessment <strong>of</strong> <strong>the</strong> GIST<br />
treatment with imat<strong>in</strong>ib response<br />
Procedure<br />
<strong>Cost</strong> per one<br />
patient [PLN]<br />
<strong>Cost</strong> difference<br />
[PLN]<br />
Average<br />
lifetime<br />
expectancy<br />
[years]<br />
<strong>PET</strong>-<strong>CT</strong> 160 401,81 1,450<br />
<strong>CT</strong> 70 691,71<br />
89 710,10<br />
0,888<br />
Effects<br />
difference<br />
(LYG)<br />
ICER<br />
[PLN/LYG]<br />
0,562 159 626,51<br />
65
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
The <strong>analysis</strong> revealed, that gastro<strong>in</strong>test<strong>in</strong>al stromal tumors response to treatment assessment<br />
us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more expensive than us<strong>in</strong>g computed tomography, but simultaneously gives a<br />
better long-term <strong>effect</strong>, measured with life years ga<strong>in</strong>ed ratio. <strong>Cost</strong>s <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong><br />
<strong>in</strong>cluded costs <strong>of</strong> <strong>the</strong> diagnostic procedure and costs <strong>of</strong> chemo<strong>the</strong>rapy until progression. The<br />
costs difference between diagnostic procedures amounts 89,710.10 PLN per one patient.<br />
Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong> one patient allows to ga<strong>in</strong> 1.450 life years. In a group <strong>of</strong> patients, where<br />
computed tomography was performed, <strong>the</strong> anticipated health <strong>effect</strong> amounts 0.888 life<br />
year. Difference <strong>of</strong> <strong>effect</strong>s between <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> amounts 0.562 LYG (life years ga<strong>in</strong>ed) i.e.<br />
approx. 205 days.<br />
Assessment <strong>of</strong> GIST response to imat<strong>in</strong>ib <strong>the</strong>rapy, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>system</strong> is more expensive, but<br />
more <strong>effect</strong>ive than computed tomography diagnostics. Incremental cost-<strong>effect</strong>iveness ratio<br />
amounts 159,626.51 PLN/LYG that means, ga<strong>in</strong><strong>in</strong>g one additional year <strong>of</strong> life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong><br />
diagnostics <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, costs 159,626.51 PLN.<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> was also performed us<strong>in</strong>g Monte Carlo simulation method for<br />
100,000 patients. Results are shown <strong>in</strong> table 42.<br />
Table 42.<br />
Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> GIST response<br />
to imat<strong>in</strong>ib assessment<br />
Parameter<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> [PLN] Effect [years] <strong>Cost</strong> [PLN] Effect [years]<br />
ICER<br />
[PLN/LYG]<br />
Average 160 093,35 1,447 70 333,04 0,886 160 000,55<br />
Standard deviation 74 897,96 0,602 90 376,71 0,638<br />
M<strong>in</strong>imal value 4 515,00 0,250 335,55 0,250<br />
Median 197 645,00 1,750 335,55 0,500<br />
Maximal value 197 645,00 1,750 193 465,55 1,750<br />
Results obta<strong>in</strong>ed us<strong>in</strong>g <strong>the</strong> Monte Carlo method do not differ from results obta<strong>in</strong>ed <strong>in</strong> <strong>the</strong><br />
cohort simulation method. Assessment <strong>of</strong> gastro<strong>in</strong>test<strong>in</strong>al stromal tumor (GIST) response to<br />
imat<strong>in</strong>ib treatment us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> rema<strong>in</strong>s more expensive and more <strong>effect</strong>ive strategy than<br />
us<strong>in</strong>g computed tomography. Difference <strong>of</strong> <strong>effect</strong>s averages amounts 0.561 <strong>of</strong> a life year.<br />
Median <strong>of</strong> <strong>the</strong> <strong>effect</strong> <strong>in</strong> a group <strong>of</strong> patient diagnosed us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> amounts 1.75 life years,<br />
and <strong>in</strong> a group <strong>of</strong> patients diagnosed with <strong>CT</strong>, <strong>the</strong> median <strong>of</strong> <strong>effect</strong> amounts 0.5 life year.<br />
Incremental cost-<strong>effect</strong>iveness ratio amounts 160,000.55 PLN/LYG that means, ga<strong>in</strong><strong>in</strong>g one<br />
-<br />
66
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
additional year <strong>of</strong> life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> diagnostics to assess <strong>the</strong> GIST response to imat<strong>in</strong>ib <strong>the</strong>rapy,<br />
<strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, costs 160,000.55 PLN.<br />
4.6. SENSITIVITY ANALYSIS<br />
One-way sensitivity <strong>analysis</strong> <strong>of</strong> comparison <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> gastro<strong>in</strong>test<strong>in</strong>al stromal tumor<br />
(GIST) response to treatment was conducted for various model parameters:<br />
• assumption <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> cost on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN (“subthreshold” <strong>PET</strong>-<strong>CT</strong> cost at<br />
7,700 procedures per year, estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong><br />
<strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report);<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> <strong>CT</strong>;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> treatment patients respond<strong>in</strong>g to <strong>the</strong> <strong>the</strong>rapy;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> treatment patients with a disease progression;<br />
• m<strong>in</strong>imal and maximal survival <strong>of</strong> patients respond<strong>in</strong>g to <strong>the</strong> <strong>the</strong>rapy and patients with<br />
<strong>the</strong> disease progression;<br />
• m<strong>in</strong>imal and maximal life expectancy <strong>of</strong> patients respond<strong>in</strong>g to treatment <strong>in</strong> case <strong>of</strong><br />
wrong diagnosis;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> obta<strong>in</strong><strong>in</strong>g test result ascerta<strong>in</strong><strong>in</strong>g response to<br />
treatment<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> obta<strong>in</strong><strong>in</strong>g correct test result ascerta<strong>in</strong><strong>in</strong>g<br />
response to treatment<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> <strong>the</strong> correct diagnosis <strong>of</strong> progression;<br />
Sensitivity <strong>analysis</strong> results for <strong>the</strong> variable model parameters are shown <strong>in</strong> table below.<br />
Table 43.<br />
Sensitivity <strong>analysis</strong> <strong>of</strong> comparison <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> assessment <strong>of</strong> GIST response to imat<strong>in</strong>ib treatment<br />
Parameter<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> [PLN] Effect [years] <strong>Cost</strong> [PLN] Effect [years]<br />
ICER [PLN/LYG]<br />
Basel<strong>in</strong>e state 160 401,81 1,450 70 691,71 0,888 159 626,51<br />
Alternative <strong>PET</strong>-<strong>CT</strong> cost 157 199,81 1,450 70 691,71 0,888 153 929,00<br />
M<strong>in</strong>imal cost <strong>of</strong> <strong>CT</strong> 160 401,81 1,450 70 621,66 0,888 159 751,16<br />
Maximal cost <strong>of</strong> <strong>CT</strong> 160 401,81 1,450 70 770,16 0,888 159 486,92<br />
67
M<strong>in</strong>imal cost <strong>of</strong> patient<br />
respond<strong>in</strong>g to <strong>the</strong>rapy<br />
treatment<br />
Maximal cost <strong>of</strong> patient<br />
respond<strong>in</strong>g to <strong>the</strong>rapy<br />
treatment<br />
M<strong>in</strong>imal cost <strong>of</strong> patient<br />
with progression<br />
treatment<br />
Maximal cost <strong>of</strong> patient<br />
with progression<br />
treatment<br />
M<strong>in</strong>imal survival <strong>of</strong><br />
patients respond<strong>in</strong>g to<br />
<strong>the</strong> <strong>the</strong>rapy<br />
Maximal survival <strong>of</strong><br />
patients respond<strong>in</strong>g to<br />
<strong>the</strong> <strong>the</strong>rapy<br />
M<strong>in</strong>imal survival <strong>of</strong><br />
patients respond<strong>in</strong>g to<br />
<strong>the</strong>rapy <strong>in</strong> case <strong>of</strong><br />
wrong diagnosis<br />
Maximal survival <strong>of</strong><br />
patients respond<strong>in</strong>g to<br />
<strong>the</strong>rapy <strong>in</strong> case <strong>of</strong><br />
wrong diagnosis<br />
M<strong>in</strong>imal survival <strong>of</strong><br />
patients with progression<br />
Maximal survival <strong>of</strong><br />
patients with progression<br />
M<strong>in</strong>imal probability <strong>of</strong><br />
obta<strong>in</strong><strong>in</strong>g test result<br />
ascerta<strong>in</strong><strong>in</strong>g response to<br />
treatment<br />
Maximal probability <strong>of</strong><br />
obta<strong>in</strong><strong>in</strong>g test result<br />
ascerta<strong>in</strong><strong>in</strong>g response to<br />
treatment<br />
M<strong>in</strong>imal probability <strong>of</strong><br />
obta<strong>in</strong><strong>in</strong>g <strong>the</strong> correct<br />
result ascerta<strong>in</strong><strong>in</strong>g<br />
response to treatment<br />
Maximal probability <strong>of</strong><br />
obta<strong>in</strong><strong>in</strong>g <strong>the</strong> correct<br />
result ascerta<strong>in</strong><strong>in</strong>g<br />
response to treatment<br />
M<strong>in</strong>imal probability <strong>of</strong><br />
obta<strong>in</strong><strong>in</strong>g correct result<br />
ascerta<strong>in</strong><strong>in</strong>g disease<br />
progression<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
111 842,20 1,450 49 446,80 0,888 111 023,84<br />
270 764,57 1,450 118 975,58 0,888 270 087,17<br />
160 126,02 1,450 70 139,96 0,888 160 117,54<br />
161 780,76 1,450 73 450,43 0,888 157 171,41<br />
160 401,81 1,010 70 691,71 0,695 284 793,97<br />
160 401,81 2,450 70 691,71 1,325 79 742,31<br />
160 401,81 1,450 70 691,71 0,798 137 592,18<br />
160 401,81 1,450 70 691,71 1,113 266 202,08<br />
160 401,81 1,440 70 691,71 0,878 159 626,51<br />
160 401,81 1,500 70 691,71 0,938 159 626,51<br />
145 766,79 1,337 53 305,92 0,781 166 296,53<br />
175 036,83 1,563 88 077,49 0,995 153 097,43<br />
153 000,52 1,383 63 763,86 0,825 159 922,33<br />
167 803,10 1,517 77 612,11 0,950 159 067,00<br />
160 401,81 1,452 70 691,71 0,899 162 224,41<br />
68
Maximal probability <strong>of</strong><br />
obta<strong>in</strong><strong>in</strong>g correct result<br />
ascerta<strong>in</strong><strong>in</strong>g disease<br />
progression<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
160 401,81 1,450 70 691,71 0,876 156 289,37<br />
Sensitivity <strong>analysis</strong> revealed stability <strong>of</strong> <strong>the</strong> performed calculations for <strong>the</strong> described<br />
alterations <strong>of</strong> parameters, characteriz<strong>in</strong>g compared diagnostic schemes. Assessment <strong>of</strong> GIST<br />
response to treatment us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> rema<strong>in</strong>s more expensive but simultaneously more<br />
<strong>effect</strong>ive than <strong>CT</strong> diagnostics. M<strong>in</strong>imal ICER value was observed <strong>in</strong> case <strong>of</strong> maximal life<br />
expectancy <strong>of</strong> patients respond<strong>in</strong>g to <strong>the</strong>rapy assumption (decrease <strong>of</strong> 50.04% from <strong>the</strong><br />
basel<strong>in</strong>e value). Maximal ICER ratio value was observed <strong>in</strong> case <strong>of</strong> assum<strong>in</strong>g <strong>the</strong> m<strong>in</strong>imal life<br />
expectancy <strong>of</strong> patient respond<strong>in</strong>g to <strong>the</strong>rapy (ICER <strong>in</strong>crease <strong>of</strong> 78.41% from <strong>the</strong> basel<strong>in</strong>e<br />
value).<br />
69
4.7. LITERATURE<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
1. Antoch G, Kanja J, Bauer S, Kuehl H, Renz<strong>in</strong>g-Koehler K, Schuette J, Bockisch A, Debat<strong>in</strong> JF,<br />
Freudenberg LS. Comparison <strong>of</strong> <strong>PET</strong>, <strong>CT</strong>, and dual-modality <strong>PET</strong>-<strong>CT</strong> imag<strong>in</strong>g for monitor<strong>in</strong>g <strong>of</strong><br />
imat<strong>in</strong>ib (STI571) <strong>the</strong>rapy <strong>in</strong> patients with gastro<strong>in</strong>test<strong>in</strong>al stromal tumors. J Nucl Med 2004 Mar; 45 (3):<br />
pp 357–365.<br />
2. The Surveillance, Epidemiology, and End Results (SEER) Program <strong>of</strong> <strong>the</strong> National Cancer Institute<br />
(NCI) [http://seer.cancer.gov].<br />
3. DeMatteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two hundred gastro<strong>in</strong>test<strong>in</strong>al<br />
stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg. 2000 Jan; 231 (1):<br />
pp 51–58.<br />
4. Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A,<br />
Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I. Progression-free survival <strong>in</strong> gastro<strong>in</strong>test<strong>in</strong>al<br />
stromal tumours with high-dose imat<strong>in</strong>ib: randomised trial. Lancet. 2004 Sep 25-Oct 1; 364 (9440): pp<br />
1127–1134.<br />
70
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
5. UNKNOWN PRIMARY ORIGIN DETE<strong>CT</strong>ION IN CASE OF<br />
CERVICAL LYMPH NODES INVOLVEMENT BY THE SQUAMOUS CELL<br />
CANCER – COST-EFFE<strong>CT</strong>IVENESS ANALYSIS – <strong>PET</strong>-<strong>CT</strong> VS <strong>CT</strong><br />
In <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> compar<strong>in</strong>g unknown primary orig<strong>in</strong> cancers diagnostics<br />
with <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong>, a decision model concern<strong>in</strong>g <strong>the</strong> diagnostics performed <strong>in</strong> case <strong>of</strong><br />
cervical lymph nodes <strong>in</strong>volvement by squamous cell carc<strong>in</strong>oma, aim<strong>in</strong>g to detect <strong>the</strong><br />
primary orig<strong>in</strong> <strong>of</strong> <strong>the</strong> cancer, was used.<br />
The efficacy <strong>of</strong> <strong>the</strong> compared diagnostic methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical part <strong>of</strong> <strong>the</strong><br />
report, entitled “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<br />
<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic<br />
diagnostics - epidemiological and cl<strong>in</strong>ical part”. Due to <strong>the</strong> possibility <strong>of</strong> construct<strong>in</strong>g <strong>the</strong><br />
model, only <strong>the</strong> results concern<strong>in</strong>g <strong>the</strong> population <strong>of</strong> patients with cervical lymph nodes<br />
<strong>in</strong>volved by squamous cell carc<strong>in</strong>oma, most commonly result<strong>in</strong>g from <strong>the</strong> head and neck<br />
malignant neoplasm (such patient comprise 2/3 <strong>of</strong> studied population), patients with<br />
metastases to o<strong>the</strong>r regions were excluded due to <strong>the</strong> difficulty <strong>in</strong> compilation homogenous<br />
cost data for <strong>the</strong> differentiated primary neoplasms. Cl<strong>in</strong>ical <strong>effect</strong>s were estimated on a basis<br />
<strong>of</strong> available data from studies or experts’ estimations. <strong>Cost</strong>s, from <strong>the</strong> Polish public payer’s<br />
perspective were estimated on a basis <strong>of</strong> <strong>the</strong> available data concern<strong>in</strong>g procedures used <strong>in</strong><br />
particular <strong>in</strong>dications, <strong>in</strong> a time horizon equal to patients’ survival.<br />
5.1. MODEL DESCRIPTION<br />
Model used <strong>in</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> concerns group <strong>of</strong> patients with head and<br />
neck lymph nodes <strong>in</strong>volved by <strong>the</strong> squamous cell carc<strong>in</strong>oma, undergo<strong>in</strong>g imag<strong>in</strong>g<br />
diagnostics to detect <strong>the</strong> primary tumor. <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> diagnostics <strong>effect</strong>s and costs were<br />
compared. Decision model, us<strong>in</strong>g a TreeAge ® 2004 (version 7) s<strong>of</strong>tware, was used <strong>in</strong> <strong>the</strong><br />
<strong>analysis</strong>. Time horizon was estimated until patient’s death, cost data were estimated from <strong>the</strong><br />
public payer’s perspective, on a basis <strong>of</strong> available <strong>in</strong>formation. The efficacy <strong>of</strong> <strong>the</strong> compared<br />
diagnostic methods was assessed <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical part <strong>of</strong> <strong>the</strong> report, entitled “Comparative cost<br />
– <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies<br />
f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics - epidemiological and<br />
cl<strong>in</strong>ical part”. Data concern<strong>in</strong>g <strong>the</strong> treatment <strong>effect</strong>s and consequences <strong>of</strong> <strong>the</strong> improper<br />
treatment, result<strong>in</strong>g from <strong>the</strong> misdiagnos<strong>in</strong>g, were obta<strong>in</strong>ed from <strong>the</strong> literature or from experts'<br />
estimation, <strong>in</strong> case <strong>of</strong> unavailable data.<br />
71
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Information concern<strong>in</strong>g <strong>effect</strong>iveness <strong>of</strong> <strong>the</strong> diagnostic test to obta<strong>in</strong> correct estimation <strong>of</strong><br />
<strong>the</strong> patient as well as data concern<strong>in</strong>g diagnostic errors were <strong>in</strong>corporated <strong>in</strong>to <strong>the</strong> model.<br />
Improper diagnostics may cause health or f<strong>in</strong>ancial losses.<br />
5.2. MODEL’S TRANSIENT STATES<br />
Decision model conta<strong>in</strong>s <strong>the</strong> follow<strong>in</strong>g transient states (equal for both variants <strong>of</strong> <strong>the</strong><br />
diagnostic procedure):<br />
• “Unknown primary orig<strong>in</strong> neoplasms” is a basel<strong>in</strong>e state, characteriz<strong>in</strong>g patients<br />
population at <strong>the</strong> beg<strong>in</strong>n<strong>in</strong>g <strong>of</strong> treatment. After <strong>the</strong> diagnostic procedure, <strong>the</strong>re is a<br />
possibility to pass <strong>in</strong>to <strong>the</strong> follow<strong>in</strong>g states:<br />
o Diagnosis: primary tumor (if <strong>the</strong> diagnostic procedure revealed primary tumor<br />
<strong>of</strong> <strong>the</strong> unknown primary orig<strong>in</strong> neoplasm);<br />
o Diagnosis: no primary tumor (if <strong>the</strong> primary tumor <strong>of</strong> <strong>the</strong> unknown primary orig<strong>in</strong><br />
neoplasm was not detected).<br />
• “Diagnosis: primary tumor” – conta<strong>in</strong>s patients with detected primary tumor <strong>of</strong> <strong>the</strong><br />
unknown primary orig<strong>in</strong> neoplasms. If <strong>the</strong> primary tumor is diagnosed, <strong>the</strong> two f<strong>in</strong>al<br />
states may occur:<br />
o Patient with primary tumor (<strong>in</strong> case <strong>of</strong> correct primary tumor diagnosis);<br />
o Patient without primary tumor (if <strong>the</strong> primary tumor was <strong>in</strong>correctly diagnosed).<br />
• “Diagnosis: no primary tumor” – this state conta<strong>in</strong>s patients without diagnosed<br />
primary tumor <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms. If no primary tumor was<br />
diagnosed, <strong>the</strong>re is a possibility to pass <strong>in</strong>to <strong>the</strong> follow<strong>in</strong>g f<strong>in</strong>al states:<br />
o Patient with primary tumor (<strong>in</strong> case <strong>of</strong> <strong>in</strong>correct lack <strong>of</strong> primary tumor<br />
diagnosis);<br />
o Patient without primary tumor (if <strong>the</strong> lack <strong>of</strong> primary tumor was correctly<br />
diagnosed).<br />
The figure below shows <strong>the</strong> illustration <strong>of</strong> <strong>the</strong> decision tree <strong>of</strong> <strong>the</strong> model, describ<strong>in</strong>g <strong>the</strong><br />
course <strong>of</strong> primary tumor <strong>in</strong> unknown primary orig<strong>in</strong> neoplasms detection, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> and<br />
computed tomography.<br />
72
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Figure 6.<br />
Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison, used <strong>in</strong> <strong>the</strong> primary tumor<br />
diagnostics <strong>in</strong> case <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms (legend – table 49)<br />
As presented <strong>in</strong> <strong>the</strong> figure 6, it is assumed that all patients with positive result <strong>of</strong> diagnostic<br />
tests had radical surgical and radiological and palliative treatment, patients with negative<br />
result had chemo-radio<strong>the</strong>rapy and palliative treatment.<br />
5.3. COSTS CALCULATION<br />
In a study concern<strong>in</strong>g <strong>the</strong> primary tumor <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms diagnostics,<br />
<strong>the</strong> hybrid <strong>PET</strong>-<strong>CT</strong> was compared to <strong>the</strong> computed tomography (<strong>CT</strong>). Computed<br />
tomography is and out-patient diagnostic service, co-f<strong>in</strong>anced (ASDW), that amounts 42<br />
po<strong>in</strong>ts – 37 po<strong>in</strong>ts are refunded by <strong>the</strong> National Health Fund and <strong>the</strong> 5 po<strong>in</strong>ts are covered by<br />
a physician referr<strong>in</strong>g to <strong>the</strong> procedure (“Catalogue <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced out-patient diagnostic<br />
procedures ranges (ASDW)”. Annex No. 1b to <strong>the</strong> <strong>in</strong>formational materials AOS). Referrer<br />
covers <strong>the</strong> cost <strong>of</strong> performed procedure, accord<strong>in</strong>g to <strong>the</strong> negotiated price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t. The<br />
National Health Fund covers <strong>the</strong> cost <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced diagnostic procedure, accord<strong>in</strong>gly<br />
to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by: health care provider perform<strong>in</strong>g <strong>the</strong> procedure and<br />
by <strong>the</strong> referrer.<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on a<br />
basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories bounded with <strong>the</strong> National<br />
Health Fund contract <strong>in</strong> Poland, amounts 8.05 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> service from <strong>the</strong> ASDW catalogue,<br />
toge<strong>the</strong>r with its cost calculation.<br />
73
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 44.<br />
Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
<strong>CT</strong>: One or more parts<br />
<strong>of</strong> <strong>the</strong> body<br />
exam<strong>in</strong>ation - with<br />
contrast media<br />
5.03.00.0000029<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
<strong>CT</strong><br />
laboratory Oncologic<br />
dispensary<br />
37 5 8,05 7,54<br />
<strong>PET</strong>-<strong>CT</strong> is a <strong>in</strong>dividually contracted service <strong>of</strong> 420 po<strong>in</strong>ts <strong>in</strong> pric<strong>in</strong>g. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz, <strong>the</strong><br />
sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Table 45.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
420 10,75<br />
Test<br />
cost<br />
(PLN)<br />
335,55<br />
Test cost [PLN]<br />
4 515,00<br />
The average <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> primary tumor <strong>of</strong> unknown primary orig<strong>in</strong><br />
neoplasms diagnostics amounts 335.55 PLN, and <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong><br />
public payer’s perspective – amounts 4,515.00 PLN.<br />
The follow<strong>in</strong>g table shows selected items, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services, used to<br />
calculate <strong>the</strong> costs <strong>of</strong> 6 cycles <strong>of</strong> chemo<strong>the</strong>rapy or 6 months <strong>of</strong> palliative chemo<strong>the</strong>rapy.<br />
Table 46.<br />
<strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services<br />
Type <strong>of</strong> <strong>the</strong><br />
<strong>the</strong>rapy<br />
PF<br />
Active substances Posology<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
100 mg/m 2 iv / day 1 // 800–1000 mg/m 2 iv<br />
days 1–4 (CONTINUOUS INFUSION 96 H<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong><br />
procedure =No<br />
<strong>of</strong> po<strong>in</strong>ts x po<strong>in</strong>t<br />
price (10 PLN)<br />
[PLN]<br />
7 148,40<br />
74
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
WITH/WITHOUT RADIOTHERAPY)<br />
MTX METHOTREXATUM 40 mg/m 2 iv day 1, every 7 days 3 098,40<br />
PFH&N<br />
PFELVH&N<br />
PF1<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
CIS-PLATINUM //<br />
FLUOROURACILUM //<br />
VINBLASTINUM // ETOPOSIDUM<br />
// CALCII FOLINAS<br />
CIS-PLATINUM //<br />
FLUOROURACILUM<br />
P CIS-PLATINUM<br />
20 mg/m 2 /day iv (cont<strong>in</strong>uous <strong>in</strong>fusion) days<br />
1–5 //<br />
500 mg/m 2 /day iv ( cont<strong>in</strong>uous <strong>in</strong>fusion)days<br />
1–7 and days 15, 22, 29 every 28 days<br />
30 mg/m 2 iv days 1–3 // 500 mg/m 2 iv days 1–<br />
3 // 3 mg/m 2 iv day 1 // 100 mg/m 2 iv days 2<br />
and 3 // 25 mg/m 2 iv days 1–3 every 21 days<br />
25 mg/m 2 iv days 1–4 // 1000 mg/m 2 iv days 1-<br />
4 every 28 days<br />
40 mg/m 2 iv day 1, every 7 days IN<br />
COMBINATION WITH RADIOTHERAPY<br />
13 963,20<br />
6 376,80<br />
7 148,40<br />
3 636,00<br />
Table 47 conta<strong>in</strong>s selected radio<strong>the</strong>rapeutic procedures, from <strong>the</strong> NHF’s catalogue <strong>of</strong><br />
services, used <strong>in</strong> unknown primary orig<strong>in</strong> neoplasms treatment.<br />
Table 47.<br />
<strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services<br />
Type <strong>of</strong> service<br />
Code <strong>of</strong> <strong>the</strong><br />
procedure<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure =No <strong>of</strong> po<strong>in</strong>ts<br />
x po<strong>in</strong>t price (10 PLN) [PLN]<br />
palliative teleradio<strong>the</strong>rapy 5.07.01.0000021 1 800<br />
radical teleradio<strong>the</strong>rapy with twodimensional<br />
(2D) plann<strong>in</strong>g<br />
radical teleradio<strong>the</strong>rapy with threedimensional<br />
(3D) plann<strong>in</strong>g<br />
5.07.01.0000022 5 000<br />
5.07.01.0000023 8 000<br />
standard brachy<strong>the</strong>rapy 5.07.01.0000025 4 000<br />
3D brachy<strong>the</strong>rapy with real time plann<strong>in</strong>g 5.07.01.0000026 5 200<br />
The table below conta<strong>in</strong>s selected procedures, from <strong>the</strong> NHF’s catalogue <strong>of</strong> services as well<br />
as cost <strong>of</strong> operative treatment <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms.<br />
Table 48.<br />
Surgical procedures used <strong>in</strong> unknown primary orig<strong>in</strong> neoplasms treatment<br />
Name <strong>of</strong> <strong>the</strong> procedure Code <strong>of</strong> <strong>the</strong> procedure<br />
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> procedure<br />
=No <strong>of</strong> po<strong>in</strong>ts x po<strong>in</strong>t price<br />
(10 PLN) [PLN]<br />
75
excision <strong>of</strong> <strong>the</strong> maxillary neoplasm – partial<br />
and total resection <strong>of</strong> <strong>the</strong> maxilla<br />
Total or partial laryngectomy with <strong>the</strong> lymph<br />
nodes operation / with or without CO2 laser /<br />
with tracheostomy<br />
Radical or modified excision <strong>of</strong> <strong>the</strong> cervical<br />
lymphatic <strong>system</strong><br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx with cervical lymph nodes<br />
excision<br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx with cervical lymph nodes<br />
excision, mandibulotomy and/or without partial<br />
mandible resection<br />
Salivary gland neoplasm excision with cervical<br />
lymphangiectomy<br />
Mandible excision (hemiresection) with<br />
possible cervical lymphangiectomy<br />
Parotid gland neoplasm excision with <strong>the</strong> facial<br />
nerve reconstruction or with facial nerve<br />
preservation<br />
Eyelid neoplasm, exceed<strong>in</strong>g over <strong>the</strong> orbit<br />
outl<strong>in</strong>e – surgical treatment<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
5.06.00.0000481 7 000<br />
5.06.00.0000682 5 200<br />
5.06.00.0000689 4 800<br />
5.06.00.0000479 7 000<br />
5.06.00.0000480 8 000<br />
5.06.00.0000482 5 000<br />
5.06.00.0000483 6 000<br />
5.06.00.0000484 4 500<br />
5.06.00.0000134 2 000<br />
Nose neoplasm excision 5.06.00.0000160 2 600<br />
Sk<strong>in</strong>/s<strong>of</strong>t tissue neoplasm excision with<br />
syn<strong>the</strong>tic implants reconstruction or with<br />
pedunculated lobes<br />
5.06.00.0000161 3 800<br />
Orbit neoplasm – surgical treatment 5.06.00.0000214 5 000<br />
Excision <strong>of</strong> <strong>the</strong> neoplasm <strong>of</strong> <strong>the</strong> oral cavity<br />
bottom, tongue, s<strong>of</strong>t palate, cheek and <strong>the</strong><br />
medial pharynx<br />
5.4. MODEL PARAMETERS<br />
Ma<strong>in</strong> model parameters are presented <strong>in</strong> <strong>the</strong> table below.<br />
5.06.00.0000478 5 000<br />
Table 49.<br />
List <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong> primary tumor<br />
<strong>of</strong> unknown primary orig<strong>in</strong> neoplasms diagnostics<br />
Parameter <strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
76
<strong>Cost</strong> <strong>of</strong> <strong>the</strong> diagnostic procedure<br />
[PLN]<br />
<strong>Cost</strong> <strong>of</strong> palliative <strong>the</strong>rapy (cPaliat)<br />
[PLN]<br />
<strong>Cost</strong> <strong>of</strong> palliative <strong>the</strong>rapy (cPaliat2)<br />
[PLN]<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
4 515,00 (1 313,00*) 335,55 (265,50; 414,00)<br />
7 148,40 (3 098,40; 13 963,20)<br />
7 148,40 (5 718,72; 8 578,08)<br />
<strong>Cost</strong> <strong>of</strong> chemo<strong>the</strong>rapy (cChem) [PLN] 7 148,40**<br />
<strong>Cost</strong> <strong>of</strong> radio<strong>the</strong>rapy (cRT) [PLN] 5 000,00 (1 800,00; 8 000,00)<br />
<strong>Cost</strong> <strong>of</strong> radical <strong>the</strong>rapy (cLeczRadyk)<br />
[PLN]<br />
Survival <strong>in</strong> case <strong>of</strong> lack <strong>of</strong> tumor or<br />
resective tumor (eP_LeczRadyk)<br />
[years]<br />
Survival <strong>in</strong> case <strong>of</strong> non-diagnosed<br />
tumor – wrong diagnosis<br />
(eP_GuzUkryty) [years]<br />
Probability <strong>of</strong> diagnostic procedure<br />
positive result<br />
5 000,00 (2 000,00; 16 000,00)<br />
5,0 (4,0; 6,0)<br />
4,0 (3,0; 5,0)<br />
0,4872 (0,4071; 0,5672) 0,3590 (0,2822; 0,4358)<br />
Probability <strong>of</strong> correct tumor detection 0,9474 (0,9116; 0,9831) 0,6429 (0,5661; 0,7196)<br />
Probability <strong>of</strong> correct lack <strong>of</strong> tumor<br />
detection<br />
0,8500 (0,7928; 0,9072) 0,5200 (0,4400; 0,6000)<br />
*“threshold” <strong>PET</strong>-<strong>CT</strong> cost at 7,700 procedures per year (estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report)<br />
** Only chemo<strong>the</strong>rapeutic regimen used <strong>in</strong> “Unknown primary orig<strong>in</strong> neoplasms – squamous cell carc<strong>in</strong>oma”<br />
<strong>in</strong>dication.<br />
• <strong>PET</strong>-<strong>CT</strong> cost amounts 4,515.00 PLN (alternative <strong>PET</strong>-<strong>CT</strong> cost, amount<strong>in</strong>g 1,313.00 PLN<br />
was also assumed – cost estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong> <strong>the</strong><br />
Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report).<br />
• The average <strong>CT</strong> cost amounts 335.55; m<strong>in</strong>imal cost <strong>of</strong> this procedure amounted 265.50<br />
PLN, maximal – 414.00 PLN.<br />
• The average cost <strong>of</strong> head and neck malignant neoplasms radical treatment was<br />
assumed as equal to <strong>the</strong> cost <strong>of</strong> procedure 5.06.00.0000482 from <strong>the</strong> catalogue <strong>of</strong> <strong>the</strong><br />
hospital services (<strong>the</strong> costs range between m<strong>in</strong>imal and maximal cost <strong>of</strong> surgical<br />
procedures used <strong>in</strong> head and neck malignant tumors treatment – see table 48).<br />
• As <strong>the</strong> average cost <strong>of</strong> palliative treatment (cPaliat) and chemo<strong>the</strong>rapy (cChem), <strong>in</strong><br />
case <strong>of</strong> no primary tumor, <strong>the</strong> cost <strong>of</strong> 6 cycles <strong>of</strong> PF chemo<strong>the</strong>rapy (form <strong>the</strong><br />
oncologic procedures catalogue) was assumed (<strong>the</strong> range <strong>of</strong> costs between m<strong>in</strong>imal<br />
and maximal cost <strong>of</strong> surgical procedures, used <strong>in</strong> head and neck malignant tumors<br />
treatment – see table 46).<br />
77
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• <strong>Cost</strong> <strong>of</strong> <strong>the</strong> palliative treatment (cPaliat2) was assumed as equal to <strong>the</strong> cost <strong>of</strong> 6<br />
cycles <strong>of</strong> PF chemo<strong>the</strong>rapy, from <strong>the</strong> oncologic services catalogue, used <strong>in</strong> unknown<br />
primary orig<strong>in</strong> cancers treatment (range +/_ 1 cycle <strong>of</strong> treatment).<br />
• The average cost <strong>of</strong> unknown primary orig<strong>in</strong> cancers <strong>in</strong>volv<strong>in</strong>g cervical lymph nodes<br />
radio<strong>the</strong>rapy was assumed as <strong>the</strong> cost <strong>of</strong> procedure No. 5.07.01.0000022 from <strong>the</strong><br />
oncologic services catalogue – teleradio<strong>the</strong>rapy, brachy<strong>the</strong>rapy and isotope <strong>the</strong>rapy<br />
(range <strong>of</strong> costs between m<strong>in</strong>imal and maximal cost <strong>of</strong> <strong>the</strong> procedures used <strong>in</strong> head<br />
and neck malignant neoplasms treatment – see table 48).<br />
• M<strong>in</strong>imal and maximal lifetime expectancy values <strong>in</strong> case <strong>of</strong> detected primary tumor,<br />
real lack <strong>of</strong> primary tumor and <strong>in</strong> case <strong>of</strong> <strong>the</strong> primary tumor not detected with<br />
imag<strong>in</strong>g studies, were assumed on a basis <strong>of</strong> <strong>the</strong> literature and estimation <strong>of</strong> experts<br />
from <strong>the</strong> Maria – Curie Skłodowska Memorial Institute Center <strong>of</strong> Oncology <strong>in</strong> Warsaw.<br />
• Values <strong>of</strong> <strong>the</strong> rest <strong>of</strong> parameters were taken from <strong>the</strong> report: “Comparative cost –<br />
<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic<br />
technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics -<br />
epidemiological and cl<strong>in</strong>ical part”. Information from <strong>the</strong> follow<strong>in</strong>g publications were<br />
used:<br />
5.5. RESULTS<br />
o Freudenberg LS, Fischer M, Antoch G, Jentzen W, Gutzeit A, Rosenbaum<br />
SJ, Bockisch A, Egelh<strong>of</strong> T. Dual modality <strong>of</strong> 18F-fluorodeoxyglucose-positron<br />
emission tomography/computed tomography <strong>in</strong> patients with cervical<br />
carc<strong>in</strong>oma <strong>of</strong> unknown primary. Med Pr<strong>in</strong>c Pract 2005; Vol. 14 (3): pp 155–160.<br />
o Gutzeit A, Antoch G, Kuhl H, Egelh<strong>of</strong> T, Fischer M, Hauth E, Goehde S, Bockisch<br />
A, Debat<strong>in</strong> J, Freudenberg L. Unknown primary tumors: detection with dual-<br />
modality <strong>PET</strong>-<strong>CT</strong>--<strong>in</strong>itial experience. Radiology 2005; Vol. 234 (1): pp 227–234.<br />
Epub 2004 Nov 24.<br />
The follow<strong>in</strong>g table shows results <strong>of</strong> <strong>the</strong> comparative cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs<br />
computed tomography used <strong>in</strong> unknown primary orig<strong>in</strong> neoplasms primary tumors detection,<br />
where <strong>the</strong> average lifetime expectancy expressed <strong>in</strong> years, was considered as <strong>the</strong> <strong>effect</strong>.<br />
Cohort simulation method was used <strong>in</strong> calculations.<br />
78
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 50.<br />
Results <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> unknown primary orig<strong>in</strong> neoplasm primary tumor<br />
diagnostics<br />
Procedure<br />
<strong>Cost</strong> per one<br />
patient [PLN]<br />
<strong>Cost</strong> difference<br />
[PLN]<br />
Average<br />
lifetime<br />
expectancy<br />
[years]<br />
<strong>PET</strong>-<strong>CT</strong> 20 329,10 4,923<br />
<strong>CT</strong> 17 066,07<br />
3 263,03<br />
4,692<br />
Effects<br />
difference<br />
(LYG)<br />
ICER<br />
[PLN/LYG]<br />
0,231 14 125,67<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> revealed, that diagnostics <strong>of</strong> primary tumors <strong>of</strong> unknown primary<br />
orig<strong>in</strong> neoplasms us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more expensive than us<strong>in</strong>g computed tomography, but<br />
simultaneously gives a better long-term <strong>effect</strong>, measured with life years ga<strong>in</strong>ed ratio. <strong>PET</strong>-<strong>CT</strong><br />
cost <strong>in</strong>cluded costs <strong>of</strong> <strong>the</strong> diagnostic procedure, surgical treatment and costs <strong>of</strong> palliative<br />
chemo<strong>the</strong>rapy. The cost difference between diagnostic procedures amounts 3,263.03 PLN<br />
per one patient. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong> one patient allows to ga<strong>in</strong> 4.923 life years. In a group <strong>of</strong><br />
patients, where computed tomography is performed, <strong>the</strong> anticipated <strong>effect</strong> amounts 4.692<br />
life years. Difference <strong>of</strong> <strong>effect</strong>s between <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong> amounts 0.231 LYG (life years ga<strong>in</strong>ed)<br />
i.e. approx. 84 days.<br />
Primary tumor <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms diagnostics, us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>system</strong> is more<br />
expensive, but more <strong>effect</strong>ive than computed tomography diagnostics. Incremental cost-<br />
<strong>effect</strong>iveness ratio amounts 14,125.67 PLN/LYG, that means, ga<strong>in</strong><strong>in</strong>g one additional year <strong>of</strong><br />
life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, costs 14,125.67 PLN.<br />
<strong>Cost</strong>-<strong>effect</strong>iveness <strong>analysis</strong> was also performed us<strong>in</strong>g Monte Carlo simulation method for<br />
100,000 patients. Results are shown <strong>in</strong> table 51.<br />
79
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 51.<br />
Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> primary tumor<br />
diagnostics <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms<br />
Parameter<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> [PLN] Effect [LYG] <strong>Cost</strong> [PLN] Effect [LYG]<br />
ICER<br />
[PLN/LYG]<br />
Average 20 336,55 4,925 17 056,99 4,696 14 321,22<br />
Standard deviation 3 572,83 0,264 3 431,80 0,460<br />
M<strong>in</strong>imal value 16 663,40 4,000 12 483,95 4,000<br />
Median 23 811,80 5,000 19 632,35 5,000<br />
Maximal value 23 811,80 5,000 19 632,35 5,000<br />
Results obta<strong>in</strong>ed us<strong>in</strong>g <strong>the</strong> Monte Carlo method do not differ from results obta<strong>in</strong>ed <strong>in</strong> <strong>the</strong><br />
cohort simulation method. <strong>PET</strong>-<strong>CT</strong> diagnostics method rema<strong>in</strong>s more expensive and more<br />
<strong>effect</strong>ive than us<strong>in</strong>g computed tomography only. Difference <strong>of</strong> <strong>effect</strong>s averages amounts<br />
0.229 <strong>of</strong> a life year. Median <strong>of</strong> <strong>the</strong> <strong>effect</strong> <strong>in</strong> a group <strong>of</strong> patient diagnosed us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong><br />
amounts 5 life years, and <strong>in</strong> <strong>CT</strong> group – also 5 life years. Incremental cost-<strong>effect</strong>iveness ratio<br />
amounts 14,321.22 PLN/LYG that means, ga<strong>in</strong><strong>in</strong>g one additional year <strong>of</strong> life us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong><br />
diagnostics <strong>in</strong> primary tumor detection <strong>in</strong> case <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms, <strong>in</strong>stead<br />
<strong>of</strong> <strong>CT</strong>, costs 14,321.22 PLN.<br />
5.6. SENSITIVITY ANALYSIS<br />
One-way sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> diagnostics <strong>in</strong> unknown primary orig<strong>in</strong><br />
neoplasms primary tumors detection was performed for <strong>the</strong> different model parameters;<br />
• assumption <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> cost on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN (“subthreshold” <strong>PET</strong>-<strong>CT</strong> cost at<br />
7,700 procedures per year, estimated <strong>in</strong> <strong>the</strong> “Assessment <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> diagnostics <strong>in</strong><br />
<strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz” report);<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> <strong>CT</strong>;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> radical treatment;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> radio<strong>the</strong>rapy;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> palliative treatment;<br />
• m<strong>in</strong>imal and maximal costs <strong>of</strong> <strong>the</strong> palliative treatment (2);<br />
• m<strong>in</strong>imal and maximal lifetime expectancy, <strong>in</strong> case <strong>of</strong> lack <strong>of</strong> tumor or <strong>in</strong> case <strong>of</strong><br />
resective tumor;<br />
-<br />
80
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
• m<strong>in</strong>imal and maximal lifetime expectancy, <strong>in</strong> case <strong>of</strong> lack <strong>of</strong> tumor or <strong>in</strong> case <strong>of</strong><br />
hidden tumor – wrong diagnosis;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> ga<strong>in</strong><strong>in</strong>g a positive result <strong>in</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> and <strong>CT</strong>;<br />
• maximal and maximal??? probability <strong>of</strong> <strong>the</strong> correct primary tumor detection;<br />
• m<strong>in</strong>imal and maximal probabilities <strong>of</strong> <strong>the</strong> correct diagnosis concern<strong>in</strong>g <strong>the</strong> lack <strong>of</strong><br />
primary tumor.<br />
Sensitivity <strong>analysis</strong> results for <strong>the</strong> variable model parameters are shown <strong>in</strong> table below.<br />
Table 52.<br />
Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> unknown primary orig<strong>in</strong> neoplasms primary tumor diagnostics<br />
Parameter<br />
<strong>PET</strong>-<strong>CT</strong> <strong>CT</strong><br />
<strong>Cost</strong> [PLN] Effect [years] <strong>Cost</strong> [PLN] Effect [years]<br />
ICER [PLN/LYG]<br />
Basel<strong>in</strong>e state 20 329,10 4,923 17 066,07 4,692 14 125,67<br />
Alternative <strong>PET</strong>-<strong>CT</strong> cost 17 127,10 4,923 17 066,07 4,692 264,20<br />
M<strong>in</strong>imal cost <strong>of</strong> <strong>CT</strong> 20 329,10 4,923 16 996,02 4,692 14 428,92<br />
Maximal cost <strong>of</strong> <strong>CT</strong> 20 329,10 4,923 17 144,52 4,692 13 786,06<br />
M<strong>in</strong>imal cost <strong>of</strong> radical<br />
treatment<br />
Maximal cost <strong>of</strong> radical<br />
treatment<br />
M<strong>in</strong>imal cost <strong>of</strong><br />
radio<strong>the</strong>rapy<br />
Maximal cost <strong>of</strong><br />
radio<strong>the</strong>rapy<br />
M<strong>in</strong>imal cost <strong>of</strong><br />
palliative<br />
chemo<strong>the</strong>rapy<br />
Maximal cost <strong>of</strong><br />
palliative<br />
chemo<strong>the</strong>rapy<br />
M<strong>in</strong>imal cost <strong>of</strong><br />
palliative<br />
chemo<strong>the</strong>rapy (2)<br />
Maximal cost <strong>of</strong><br />
palliative<br />
chemo<strong>the</strong>rapy (2)<br />
18 867,50 4,923 15 989,07 4,692 12 460,74<br />
25 688,30 4,923 21 015,07 4,692 20 230,43<br />
18 688,14 4,923 15 014,87 4,692 15 901,60<br />
21 867,50 4,923 18 989,07 4,692 12 460,74<br />
18 148,20 4,923 14 885,23 4,692 14 125,41<br />
23 998,82 4,923 20 735,72 4,692 14 125,97<br />
19 669,29 4,923 16 406,25 4,692 14 125,71<br />
20 988,91 4,923 17 725,90 4,692 14 125,58<br />
81
M<strong>in</strong>imal survival <strong>in</strong> case<br />
<strong>of</strong> lack <strong>of</strong> tumor or<br />
resective tumor<br />
Maximal survival <strong>in</strong><br />
case <strong>of</strong> lack <strong>of</strong> tumor or<br />
resective tumor<br />
M<strong>in</strong>imal survival <strong>in</strong> case<br />
<strong>of</strong> hidden tumor – wrong<br />
diagnosis<br />
Maximal survival <strong>in</strong><br />
case <strong>of</strong> hidden tumor –<br />
wrong diagnosis<br />
M<strong>in</strong>imal probability <strong>of</strong><br />
<strong>PET</strong>-<strong>CT</strong> diagnostic<br />
procedure positive<br />
result<br />
Maximal probability <strong>of</strong><br />
<strong>PET</strong>-<strong>CT</strong> diagnostic<br />
procedure positive<br />
result<br />
M<strong>in</strong>imal probability <strong>of</strong><br />
<strong>CT</strong> diagnostic<br />
procedure positive<br />
result<br />
Maximal probability <strong>of</strong><br />
<strong>CT</strong> diagnostic<br />
procedure positive<br />
result<br />
M<strong>in</strong>imal probability <strong>of</strong><br />
<strong>the</strong> correct primary<br />
tumor detection<br />
Maximal probability <strong>of</strong><br />
<strong>the</strong> correct primary<br />
tumor detection<br />
M<strong>in</strong>imal probability <strong>of</strong><br />
<strong>the</strong> correct lack <strong>of</strong><br />
primary tumor detection<br />
Maximal probability <strong>of</strong><br />
<strong>the</strong> correct lack <strong>of</strong><br />
primary tumor detection<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
20 329,10 4,000 17 066,07 4,000<br />
Dom<strong>in</strong>ated<br />
<strong>the</strong>rapy<br />
20 329,10 5,846 17 066,07 5,385 7 078,16<br />
20 329,10 4,846 17 066,07 4,385 7 078,16<br />
20 329,10 5,000 17 066,07 5,000<br />
Dom<strong>in</strong>ated<br />
<strong>the</strong>rapy<br />
20 901,69 4,911 17 066,07 4,692 17 514,25<br />
19 757,23 4,935 17 066,07 4,692 11 074,73<br />
20 329,10 4,923 17 615,07 4,655 10 126,98<br />
20 329,10 4,923 16 517,08 4,729 19 649,59<br />
20 329,10 4,923 17 066,07 4,692 14 125,67<br />
20 329,10 4,923 17 066,07 4,692 14 125,67<br />
20 329,10 4,894 17 066,07 4,641 12 897,35<br />
20 329,10 4,952 17 066,07 4,744 15 687,64<br />
Generally, <strong>the</strong> sensitivity <strong>analysis</strong> did not reveal any sudden costs and <strong>effect</strong>s changes, for<br />
<strong>the</strong> mentioned parameters alterations, characteriz<strong>in</strong>g compared diagnostic schemes.<br />
Diagnostics <strong>of</strong> primary tumor <strong>in</strong> unknown primary orig<strong>in</strong> neoplasms us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> rema<strong>in</strong>s more<br />
expensive and more <strong>effect</strong>ive than <strong>CT</strong> diagnostics, only if <strong>the</strong> m<strong>in</strong>imal survival <strong>in</strong> case <strong>of</strong> lack<br />
<strong>of</strong> tumor or resective tumor is assumed or <strong>in</strong> case <strong>of</strong> <strong>the</strong> maximal survival <strong>of</strong> patients with<br />
hidden tumor (wrong diagnosis) <strong>the</strong> program was dom<strong>in</strong>ated, i.e. <strong>PET</strong>-<strong>CT</strong> diagnostics was<br />
more expensive and equally <strong>effect</strong>ive as <strong>CT</strong> diagnostics. The lowest ICER value was observed<br />
<strong>in</strong> case <strong>of</strong> assumption <strong>the</strong> alternative cost <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> procedure on <strong>the</strong> level <strong>of</strong> 1,313.00 PLN<br />
(decrease <strong>of</strong> 98.13% from <strong>the</strong> basel<strong>in</strong>e value). Maximal ICER ratio value was observed <strong>in</strong> case<br />
<strong>of</strong> assum<strong>in</strong>g <strong>the</strong> maximal cost <strong>of</strong> radical treatment (ICER <strong>in</strong>crease <strong>of</strong> 43.22% from <strong>the</strong> basel<strong>in</strong>e<br />
value).<br />
82
5.7. LITERATURE<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
1. Freudenberg LS, Fischer M, Antoch G, Jentzen W, Gutzeit A, Rosenbaum SJ, Bockisch A, Egelh<strong>of</strong> T.<br />
Dual modality <strong>of</strong> 18F-fluorodeoxyglucose-positron emission tomography/computed tomography <strong>in</strong><br />
patients with cervical carc<strong>in</strong>oma <strong>of</strong> unknown primary. Med Pr<strong>in</strong>c Pract 2005; Vol. 14 (3): pp 155–160.<br />
2. Gutzeit A, Antoch G, Kuhl H, Egelh<strong>of</strong> T, Fischer M, Hauth E, Goehde S, Bockisch A, Debat<strong>in</strong> J,<br />
Freudenberg L. Unknown primary tumors: detection with dual-modality <strong>PET</strong>-<strong>CT</strong>--<strong>in</strong>itial experience.<br />
Radiology 2005; Vol. 234 (1): pp 227–234. Epub 2004 Nov 24.<br />
3. The Surveillance, Epidemiology, and End Results (SEER) Program <strong>of</strong> <strong>the</strong> National Cancer Institute<br />
(NCI) [http://seer.cancer.gov].<br />
4. Pavlidis N, Briasoulis E, Ha<strong>in</strong>sworth J, et al. Diagnostic and <strong>the</strong>rapeutic management <strong>of</strong> cancer <strong>of</strong> an<br />
unknown primary. Eur J Cancer 2003; 39 (14): pp 1990–2005.<br />
5. DeSanto LW, Neel HB 3 rd . Squamous cell carc<strong>in</strong>oma. Metastasis to <strong>the</strong> neck from an unknown or<br />
undiscovered primary. Otolaryngol Cl<strong>in</strong> North Am 1985; 18 (3): pp 505–513.<br />
83
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
6. OVARIAN CANCER – COST-COMPARISON ANALYSIS – <strong>PET</strong>-<strong>CT</strong><br />
VS <strong>CT</strong><br />
This <strong>in</strong>dication was <strong>in</strong>itially qualified to <strong>the</strong> <strong>analysis</strong> us<strong>in</strong>g <strong>the</strong> ICER ratio, because <strong>of</strong> <strong>the</strong><br />
statistically significant differences <strong>in</strong> diagnostic <strong>effect</strong>iveness parameters <strong>of</strong> <strong>the</strong> compared<br />
imag<strong>in</strong>g techniques (see: “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission<br />
tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong><br />
<strong>the</strong> oncologic diagnostics - epidemiological and cl<strong>in</strong>ical part”). Data from <strong>the</strong> follow<strong>in</strong>g<br />
publications were used <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>analysis</strong>:<br />
1. Hauth EA, Antoch G, Stattaus J, Kuehl H, Veit P. Evaluation <strong>of</strong> <strong>in</strong>tegrated whole-body<br />
<strong>PET</strong>/ <strong>CT</strong> <strong>in</strong> detection <strong>of</strong> recurrent ovarian cancer. Eur J Radiol 2005 Nov; 56 (2): pp 263–<br />
268.<br />
2. Makhija S, Howden N, Edwards R, Kelley J, Townsed DW, Meltzer CC. Positron emission<br />
tomography/computed tomography imag<strong>in</strong>g for <strong>the</strong> detection <strong>of</strong> recurrent ovarian<br />
and fallopian tube carc<strong>in</strong>oma; a retrospective review. Gynecol Oncol 2002 Apr; 85<br />
(1): pp 53–58.<br />
Accord<strong>in</strong>g to <strong>the</strong> op<strong>in</strong>ion <strong>of</strong> experts from <strong>the</strong> Maria Skłodowska-Curie Memorial Institute<br />
Center <strong>of</strong> Oncology <strong>in</strong> Warsaw, due to <strong>the</strong> lack <strong>of</strong> change <strong>in</strong> <strong>the</strong> prognosis <strong>in</strong> case <strong>of</strong> early<br />
ovarian cancer recurrence after treatment, <strong>the</strong> <strong>analysis</strong> with <strong>the</strong> ICER ratio is not possible to<br />
perform. Higher diagnostic <strong>effect</strong>iveness <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>in</strong> comparison to <strong>CT</strong> does not <strong>in</strong>fluence <strong>the</strong><br />
cl<strong>in</strong>ical <strong>effect</strong>iveness. Lack <strong>of</strong> <strong>the</strong> difference <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>effect</strong> makes perform<strong>in</strong>g <strong>analysis</strong>,<br />
utiliz<strong>in</strong>g ICER ratio, impossible.<br />
The cost-comparison <strong>analysis</strong> was performed and its results are presented below.<br />
6.1. COSTS CALCULATION<br />
In a study concern<strong>in</strong>g <strong>the</strong> ovarian cancer diagnostics, <strong>the</strong> hybrid <strong>PET</strong>-<strong>CT</strong> was compared to<br />
<strong>the</strong> computed tomography (<strong>CT</strong>). Computed tomography is and out-patient diagnostic<br />
service, co-f<strong>in</strong>anced (ASDW), that amounts 42 po<strong>in</strong>ts – 37 po<strong>in</strong>ts are refunded by <strong>the</strong> National<br />
Health Fund and <strong>the</strong> 5 po<strong>in</strong>ts are covered by a physician referr<strong>in</strong>g to <strong>the</strong> procedure<br />
(“Catalogue <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced out-patient diagnostic procedures ranges (ASDW)”. Annex<br />
No. 1b to <strong>the</strong> <strong>in</strong>formational materials AOS). Referrer covers <strong>the</strong> cost <strong>of</strong> performed procedure,<br />
accord<strong>in</strong>g to <strong>the</strong> negotiated price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t. The National Health Fund covers <strong>the</strong> cost <strong>of</strong><br />
<strong>the</strong> co-f<strong>in</strong>anced diagnostic procedure, accord<strong>in</strong>gly to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by:<br />
health care provider perform<strong>in</strong>g <strong>the</strong> procedure and by <strong>the</strong> referrer.<br />
84
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on a<br />
basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories bounded with <strong>the</strong> National<br />
Health Fund contract <strong>in</strong> Poland, amounts 8.05 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> service from <strong>the</strong> ASDW catalogue,<br />
toge<strong>the</strong>r with its cost calculation.<br />
Table 53.<br />
Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
<strong>CT</strong>: One or more parts<br />
<strong>of</strong> <strong>the</strong> body<br />
exam<strong>in</strong>ation - with<br />
contrast media<br />
5.03.00.0000029<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
<strong>CT</strong><br />
laboratory Oncologic<br />
dispensary<br />
37 5 8,05 7,54<br />
<strong>PET</strong>-<strong>CT</strong> is a <strong>in</strong>dividually contracted service <strong>of</strong> 420 po<strong>in</strong>ts <strong>in</strong> pric<strong>in</strong>g. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz, <strong>the</strong><br />
sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Table 54.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
420 10,75<br />
Test<br />
cost<br />
(PLN)<br />
335,55<br />
Test cost [PLN]<br />
4 515,00<br />
The average <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> ovarian cancer amounts 335.55<br />
PLN, and <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong> public payer’s perspective – amounts<br />
4,515.00 PLN.<br />
85
6.2. RESULTS<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
The follow<strong>in</strong>g table conta<strong>in</strong>s results <strong>of</strong> <strong>the</strong> comparative cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
vs computed tomography <strong>in</strong> <strong>the</strong> ovarian cancer recurrences detection.<br />
Table 55.<br />
Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> ovarian cancer recurrence diagnostics<br />
Procedure <strong>Cost</strong> per one patient [PLN] <strong>Cost</strong> difference [PLN]<br />
<strong>PET</strong>-<strong>CT</strong> 4 515,00<br />
<strong>CT</strong> 335,55<br />
4 179,45<br />
The results <strong>of</strong> <strong>analysis</strong> show that ovarian cancer recurrence diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more<br />
expensive than computed tomography.<br />
86
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
7. OESOPHAGEAL CANCER – COST-COMPARISON ANALYSIS –<br />
<strong>PET</strong>-<strong>CT</strong> VS <strong>CT</strong> VE EUS-FNA<br />
This <strong>in</strong>dication was <strong>in</strong>itially qualified to <strong>the</strong> <strong>analysis</strong>, because <strong>of</strong> <strong>the</strong> statistically significant<br />
differences <strong>in</strong> diagnostic <strong>effect</strong>iveness parameters <strong>of</strong> <strong>the</strong> compared imag<strong>in</strong>g techniques<br />
(see: “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with<br />
diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic<br />
diagnostics - epidemiological and cl<strong>in</strong>ical part”). Data from <strong>the</strong> follow<strong>in</strong>g publications were<br />
used <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>analysis</strong>:<br />
1. Cerfolio RJ, Bryant AS, Ohja B, Bartolucci AA, Eloubeidi MA. The accuracy <strong>of</strong><br />
endoscopic ultrasonography with f<strong>in</strong>e-needle aspiration, <strong>in</strong>tegrated positron emission<br />
tomography with computed tomography, and computed tomography <strong>in</strong> restag<strong>in</strong>g<br />
patients with esophageal cancer after neoadjuvant chemoradio<strong>the</strong>rapy. J Thorac<br />
Cardiovasc Surg 2005; Vol. 129 (6): pp 1232–1241.<br />
Due to <strong>the</strong> lack <strong>of</strong> possibility to utilize data concern<strong>in</strong>g diagnostic <strong>effect</strong>iveness <strong>of</strong><br />
compared methods <strong>in</strong> cl<strong>in</strong>ical advancement assessment, after neoadiuvant oesophageal<br />
cancer treatment and before perform<strong>in</strong>g surgical procedure, <strong>in</strong> <strong>the</strong> <strong>analysis</strong> with ICER ratio,<br />
such <strong>analysis</strong> was not performed.<br />
Available data concerned <strong>effect</strong>iveness <strong>of</strong> diagnostic methods <strong>in</strong> assess<strong>in</strong>g local<br />
advancement <strong>of</strong> <strong>the</strong> cancer, lymph nodes <strong>in</strong>volvement and metastases detection. Lack <strong>of</strong><br />
<strong>the</strong> comb<strong>in</strong>ed cl<strong>in</strong>ical <strong>in</strong>formation evaluat<strong>in</strong>g diagnostic <strong>effect</strong>iveness <strong>of</strong> analyzed methods<br />
<strong>in</strong> a full TNM scale made classification <strong>the</strong> analyzed population <strong>in</strong>to groups <strong>of</strong> particular<br />
prognosis and treatment regimen impossible. Data concern<strong>in</strong>g diagnostic <strong>effect</strong>iveness, not<br />
<strong>in</strong>fluenc<strong>in</strong>g <strong>the</strong> cl<strong>in</strong>ical <strong>effect</strong>s and costs, cannot be used <strong>in</strong> construct<strong>in</strong>g a model <strong>of</strong> <strong>analysis</strong><br />
utiliz<strong>in</strong>g ICER ratio.<br />
The cost-comparison <strong>analysis</strong> was performed and its results are presented below.<br />
7.1. COSTS CALCULATION<br />
In a study concern<strong>in</strong>g <strong>the</strong> reassessment <strong>of</strong> <strong>the</strong> cl<strong>in</strong>ical stage <strong>of</strong> patients with <strong>the</strong><br />
oesophageal cancer, after <strong>the</strong> neoadiuvant <strong>the</strong>rapy (restag<strong>in</strong>g), <strong>the</strong> hybrid <strong>PET</strong>-<strong>CT</strong> was<br />
compared to <strong>the</strong> computed tomography (<strong>CT</strong>) and with <strong>the</strong> transoesophageal ultrasound-<br />
guided f<strong>in</strong>e needle aspiration biopsy (EUS-FNA).<br />
Computed tomography is an out-patient, co-f<strong>in</strong>anced (ASDW) diagnostic service, that<br />
amounts 42 po<strong>in</strong>ts – 37 po<strong>in</strong>ts are refunded by <strong>the</strong> National Health Fund and <strong>the</strong> rema<strong>in</strong><strong>in</strong>g 5<br />
87
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
po<strong>in</strong>ts are covered by a physician referr<strong>in</strong>g to <strong>the</strong> procedure (“Catalogue <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced<br />
out-patient diagnostic procedures ranges (ASDW)”. Annex No. 1b to <strong>the</strong> <strong>in</strong>formational<br />
materials AOS). Referrer covers <strong>the</strong> cost <strong>of</strong> performed procedure, accord<strong>in</strong>g to <strong>the</strong><br />
negotiated price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t. The National Health Fund covers <strong>the</strong> cost <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced<br />
diagnostic procedure, accord<strong>in</strong>gly to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by: health care<br />
provider perform<strong>in</strong>g <strong>the</strong> procedure and by <strong>the</strong> referrer.<br />
Similarly to <strong>the</strong> previous chapters, it was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic<br />
dispensary. The average price <strong>of</strong> <strong>the</strong> settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated<br />
on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract<br />
(data <strong>in</strong> <strong>the</strong> annex), amounts 7.54 PLN.<br />
The average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on <strong>the</strong> basis<br />
<strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories hav<strong>in</strong>g <strong>the</strong> contract with <strong>the</strong><br />
National Health Fund <strong>in</strong> Poland, amounts 8.05 PLN.<br />
Transoesophageal ultrasound-guided f<strong>in</strong>e needle aspiration biopsy (EUS-FNA) is a<br />
diagnostic procedure, not co-f<strong>in</strong>anced, amount<strong>in</strong>g 15 po<strong>in</strong>ts.<br />
The price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t for <strong>the</strong> f<strong>in</strong>e needle biopsy <strong>of</strong> <strong>the</strong> focal lesion, us<strong>in</strong>g <strong>the</strong> imag<strong>in</strong>g<br />
technique with <strong>the</strong> cytologic exam<strong>in</strong>ation (2-4 smears; necessary photographic<br />
documentation <strong>of</strong> <strong>the</strong> needle tip <strong>in</strong> <strong>the</strong> punctured lesion) <strong>in</strong> <strong>the</strong> general surgery ward<br />
amounts 11.00 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> and EUS-FNA as well as its costs<br />
calculations.<br />
Table 56.<br />
Service characteristics and <strong>the</strong> computed tomography and transoesophageal ultrasound-guided f<strong>in</strong>e needle aspiration<br />
biopsy (EUS-FNA) costs calculations<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
EUS-FNA<br />
Name and code <strong>of</strong><br />
<strong>the</strong> procedure<br />
<strong>CT</strong>: One or more parts <strong>of</strong><br />
<strong>the</strong> body exam<strong>in</strong>ation -<br />
with contrast media<br />
5.03.00.0000029<br />
F<strong>in</strong>e needle biopsy <strong>of</strong><br />
one focal lesion, us<strong>in</strong>g<br />
<strong>the</strong> imag<strong>in</strong>g technique<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
NHF refund<br />
Oncologic<br />
dispensary<br />
37 5 8,05 7,54<br />
Test<br />
cost<br />
(PLN)<br />
335,55<br />
15 - 11,00 - 165,00<br />
88
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
with <strong>the</strong> cytologic<br />
exam<strong>in</strong>ation (2-4 smears;<br />
necessary photographic<br />
documentation <strong>of</strong> <strong>the</strong><br />
needle tip <strong>in</strong> <strong>the</strong><br />
punctured lesion)<br />
5.05.00.0000046<br />
<strong>PET</strong>-<strong>CT</strong> is a <strong>in</strong>dividually contracted service <strong>of</strong> 420 po<strong>in</strong>ts <strong>in</strong> pric<strong>in</strong>g. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz<br />
amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Table 57.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> cost calculation<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
420 10,75<br />
Test cost [PLN]<br />
4 515,00<br />
In case <strong>of</strong> oesophageal cancer restag<strong>in</strong>g, <strong>the</strong> cost <strong>of</strong> <strong>the</strong> computed tomography (<strong>CT</strong>)<br />
amounts 335.55 PLN, and <strong>the</strong> estimated cost <strong>of</strong> <strong>the</strong> comparative test, i.e. transoesophageal<br />
ultrasound-guided f<strong>in</strong>e needle aspiration biopsy (EUS-FNA) amounted 165.00 PLN. <strong>Cost</strong> <strong>of</strong> <strong>the</strong><br />
<strong>PET</strong>-<strong>CT</strong> procedure – from <strong>the</strong> public payer's perspective – amounts 4,515.00 PLN.<br />
7.2. RESULTS<br />
The follow<strong>in</strong>g table conta<strong>in</strong>s results <strong>of</strong> <strong>the</strong> comparative cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
vs computed tomography <strong>in</strong> <strong>the</strong> oesophageal cancer cl<strong>in</strong>ical advancement assessment,<br />
after neoadiuvant treatment.<br />
89
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 58.<br />
Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> vs EUS-FNA <strong>in</strong> <strong>the</strong> oesophageal cancer cl<strong>in</strong>ical<br />
advancement assessment, after neoadiuvant treatment<br />
Procedure <strong>Cost</strong> per one patient [PLN]<br />
<strong>PET</strong>-<strong>CT</strong> 4 515,00<br />
<strong>Cost</strong>s difference (<strong>PET</strong>-<strong>CT</strong> – <strong>CT</strong> and<br />
<strong>PET</strong>-<strong>CT</strong> – EUS-FNA) [PLN]<br />
<strong>CT</strong> 335,55 4 179,45<br />
EUS-FNA 165,00 4 350,00<br />
The results <strong>of</strong> <strong>analysis</strong> show that oesophageal cancer cl<strong>in</strong>ical advancement, after<br />
neoadiuvant treatment assessment us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more expensive than computed<br />
tomography or EUS-FNA.<br />
90
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
8. LYMPHOMAS – COST-COMPARISON ANALYSIS – <strong>PET</strong>-<strong>CT</strong> VS <strong>CT</strong><br />
This <strong>in</strong>dication was <strong>in</strong>itially qualified to <strong>the</strong> <strong>analysis</strong>, because <strong>of</strong> <strong>the</strong> statistically significant<br />
differences <strong>in</strong> diagnostic <strong>effect</strong>iveness parameters <strong>of</strong> <strong>the</strong> compared imag<strong>in</strong>g techniques<br />
(see: “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with<br />
diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic<br />
diagnostics - epidemiological and cl<strong>in</strong>ical part”). Data from <strong>the</strong> follow<strong>in</strong>g publications were<br />
used <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>analysis</strong>:<br />
1. Freudenberg LS, Antoch G, Schütt P, Beyer T, Jentzen W, Müller SP, Görges R,<br />
Nowrousian MR, Bockisch A, Debat<strong>in</strong> JF. FDG-<strong>PET</strong>-<strong>CT</strong> <strong>in</strong> re-stag<strong>in</strong>g <strong>of</strong> patients with<br />
lymphoma. Eur J Nucl Med Mol Imag<strong>in</strong>g 2004; 31 (3): pp 325–329.<br />
2. Schaefer NG, Hany TF, Taverna C, Seifert B, Stumpe KD, von Schul<strong>the</strong>ss GK, Goerres<br />
GW. Non-Hodgk<strong>in</strong> lymphoma and Hodgk<strong>in</strong> disease: coregistered FDG <strong>PET</strong> and <strong>CT</strong> at<br />
stag<strong>in</strong>g and restag<strong>in</strong>g – do we need contrast-enhanced <strong>CT</strong>? Radiology 2004 Sep; 232<br />
(3): pp 823–829.<br />
Accord<strong>in</strong>g to <strong>the</strong> op<strong>in</strong>ion <strong>of</strong> experts from <strong>the</strong> Maria Skłodowska-Curie Memorial Institute<br />
Center <strong>of</strong> Oncology <strong>in</strong> Warsaw, due to <strong>the</strong> lack <strong>of</strong> change <strong>in</strong> <strong>the</strong> prognosis <strong>in</strong> case <strong>of</strong> early<br />
lymphomas recurrence after treatment, <strong>the</strong> <strong>analysis</strong> with <strong>the</strong> ICER ratio is not possible to<br />
perform. Lack <strong>of</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>effect</strong>s difference makes perform<strong>in</strong>g such <strong>analysis</strong> impossible.<br />
The cost-comparison <strong>analysis</strong> was performed and its results are presented below.<br />
8.1. COSTS CALCULATION<br />
In a study concern<strong>in</strong>g <strong>the</strong> lymphomas diagnostics, <strong>the</strong> hybrid <strong>PET</strong>-<strong>CT</strong> was compared to <strong>the</strong><br />
computed tomography (<strong>CT</strong>). Computed tomography is and out-patient diagnostic service,<br />
co-f<strong>in</strong>anced (ASDW), that amounts 42 po<strong>in</strong>ts – 37 po<strong>in</strong>ts are refunded by <strong>the</strong> National Health<br />
Fund and <strong>the</strong> 5 po<strong>in</strong>ts are covered by a physician referr<strong>in</strong>g to <strong>the</strong> procedure (“Catalogue <strong>of</strong><br />
<strong>the</strong> co-f<strong>in</strong>anced out-patient diagnostic procedures ranges (ASDW)”. Annex No. 1b to <strong>the</strong><br />
<strong>in</strong>formational materials AOS). Referrer covers <strong>the</strong> cost <strong>of</strong> performed procedure, accord<strong>in</strong>g to<br />
<strong>the</strong> negotiated price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t. The National Health Fund covers <strong>the</strong> cost <strong>of</strong> <strong>the</strong> co-<br />
f<strong>in</strong>anced diagnostic procedure, accord<strong>in</strong>gly to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by: health<br />
care provider perform<strong>in</strong>g <strong>the</strong> procedure and by <strong>the</strong> referrer.<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
91
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on a<br />
basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories bounded with <strong>the</strong> National<br />
Health Fund contract <strong>in</strong> Poland, amounts 8.05 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> service from <strong>the</strong> ASDW catalogue,<br />
toge<strong>the</strong>r with its cost calculation.<br />
Table 59.<br />
Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
<strong>CT</strong>: One or more parts<br />
<strong>of</strong> <strong>the</strong> body<br />
exam<strong>in</strong>ation - with<br />
contrast media<br />
5.03.00.0000029<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
<strong>CT</strong><br />
laboratory Oncologic<br />
dispensary<br />
37 5 8,05 7,54<br />
<strong>PET</strong>-<strong>CT</strong> is a <strong>in</strong>dividually contracted service <strong>of</strong> 420 po<strong>in</strong>ts <strong>in</strong> pric<strong>in</strong>g. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz, <strong>the</strong><br />
sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Table 60.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
420 10,75<br />
Test<br />
cost<br />
(PLN)<br />
335,55<br />
Test cost [PLN]<br />
4 515,00<br />
The average <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> lymphomas amounts 335.55 PLN,<br />
and <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong> public payer’s perspective – amounts 4,515.00<br />
PLN.<br />
92
8.2. RESULTS<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
The follow<strong>in</strong>g table conta<strong>in</strong>s results <strong>of</strong> <strong>the</strong> comparative cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
vs computed tomography <strong>in</strong> <strong>the</strong> lymphomas recurrences detection.<br />
Table 61.<br />
Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> lymphomas recurrence diagnostics<br />
Procedure <strong>Cost</strong> per one patient [PLN] <strong>Cost</strong> difference [PLN]<br />
<strong>PET</strong>-<strong>CT</strong> 4 515,00<br />
<strong>CT</strong> 335,55<br />
4 179,45<br />
The results <strong>of</strong> <strong>analysis</strong> show that lymphomas recurrence diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more<br />
expensive than computed tomography.<br />
93
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
9. THYROID CANCER – COST-COMPARISON ANALYSIS – <strong>PET</strong>-<strong>CT</strong><br />
VS WHOLE-BODY SCINTIGRAPHY<br />
This <strong>in</strong>dication was <strong>in</strong>itially qualified to <strong>the</strong> <strong>analysis</strong>, because <strong>of</strong> <strong>the</strong> statistically significant<br />
differences <strong>in</strong> diagnostic <strong>effect</strong>iveness parameters <strong>of</strong> <strong>the</strong> compared imag<strong>in</strong>g techniques<br />
(see: “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with<br />
diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic<br />
diagnostics - epidemiological and cl<strong>in</strong>ical part”). Data from <strong>the</strong> follow<strong>in</strong>g publications were<br />
used <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>analysis</strong>:<br />
1. Nahas Z, Goldenberg D, Fakhry C, Ewertz M, Zeiger M, Ladenson PW, Wahl R, Tufano<br />
RP. The role <strong>of</strong> positron emission tomography/computed tomography <strong>in</strong> <strong>the</strong><br />
management <strong>of</strong> recurrent papillary thyroid carc<strong>in</strong>oma. Laryngoscope 2005 Feb; 115<br />
(2): pp 237–243.<br />
2. Freudenberg LS, Antoch G, Jentzen W, P<strong>in</strong>k R, Knust J, Gorges R, Muller SP, Bockisch A,<br />
Debat<strong>in</strong> JF, Brandau W. Value <strong>of</strong> 124I -<strong>PET</strong>-<strong>CT</strong> <strong>in</strong> stag<strong>in</strong>g <strong>of</strong> patients with differentiated<br />
thyroid cancer. Eur Radiol 2004; Vol. 14 (11): pp 2092–2098.<br />
3. Zimmer LA, McCook B, Meltzer C, Fukui M, Bascom D, Snyderman C, Townsend DW,<br />
Johnson JT. Comb<strong>in</strong>ed positron emission tomography/computed tomography<br />
imag<strong>in</strong>g <strong>of</strong> recurrent thyroid cancer. Otolaryngology – Head & Neck Surgery 2003;<br />
Vol. 128 (2): pp 178–184.<br />
Accord<strong>in</strong>g to <strong>the</strong> op<strong>in</strong>ion <strong>of</strong> experts from <strong>the</strong> Maria Skłodowska-Curie Memorial Institute<br />
Center <strong>of</strong> Oncology <strong>in</strong> Warsaw, due to <strong>the</strong> lack <strong>of</strong> change <strong>in</strong> <strong>the</strong> prognosis <strong>in</strong> case <strong>of</strong> early<br />
thyroid cancer recurrence after treatment, <strong>the</strong> <strong>analysis</strong> with <strong>the</strong> ICER ratio is not possible to<br />
perform. In a prelim<strong>in</strong>ary assessment <strong>of</strong> <strong>the</strong> thyroid cancer cl<strong>in</strong>ical advancement, <strong>the</strong> <strong>PET</strong>-<strong>CT</strong><br />
method is not <strong>in</strong>dicated. Lack <strong>of</strong> <strong>the</strong> difference <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>effect</strong> makes perform<strong>in</strong>g<br />
<strong>analysis</strong>, utiliz<strong>in</strong>g ICER ratio, impossible.<br />
The cost-comparison <strong>analysis</strong> was performed and its results are presented below.<br />
9.1. COSTS CALCULATION<br />
In <strong>the</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> thyroid cancer recurrence diagnostics, on a basis <strong>of</strong> <strong>the</strong> cl<strong>in</strong>ical report,<br />
<strong>the</strong> diagnostic method compared with <strong>PET</strong>-<strong>CT</strong> was I 131 whole-body sc<strong>in</strong>tigraphy. Sc<strong>in</strong>tigraphy<br />
is an out-patient diagnostic, co-f<strong>in</strong>anced (ASDW) procedure, that amounts 30 po<strong>in</strong>ts – 25<br />
po<strong>in</strong>ts are refunded by <strong>the</strong> National Health Fund and <strong>the</strong> 5 rema<strong>in</strong><strong>in</strong>g po<strong>in</strong>ts are covered by<br />
a physician referr<strong>in</strong>g to <strong>the</strong> procedure (“Catalogue <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced out-patient diagnostic<br />
procedures ranges (ASDW)”. Annex No. 1b to <strong>the</strong> <strong>in</strong>formational materials AOS). Referrer<br />
covers <strong>the</strong> cost <strong>of</strong> performed procedure, accord<strong>in</strong>g to <strong>the</strong> negotiated price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t. The<br />
94
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
National Health Fund covers <strong>the</strong> cost <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced diagnostic procedure, accord<strong>in</strong>gly<br />
to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by: health care provider perform<strong>in</strong>g <strong>the</strong> procedure and<br />
by <strong>the</strong> referrer.<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>of</strong> <strong>the</strong> sc<strong>in</strong>tigraphy, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t<br />
price <strong>in</strong> all dispensaries hav<strong>in</strong>g <strong>the</strong> contract with <strong>the</strong> National Health Fund <strong>in</strong> Poland, amounts<br />
8.05 PLN.<br />
The table below shows <strong>the</strong> po<strong>in</strong>ts prices <strong>of</strong> <strong>the</strong> I 131 whole-body sc<strong>in</strong>tigraphy and <strong>the</strong> value <strong>of</strong><br />
<strong>the</strong> settlement po<strong>in</strong>t (<strong>in</strong> PLN).<br />
Table 62.<br />
Service characteristics and <strong>the</strong> whole-body sc<strong>in</strong>tigraphy cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
I 131 whole-body<br />
sc<strong>in</strong>tigraphy<br />
Name and code <strong>of</strong><br />
<strong>the</strong> procedure<br />
Whole-body<br />
sc<strong>in</strong>tigraphy (skeletal<br />
<strong>system</strong>)<br />
5.03.00.0000020<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
NHF refund Oncologic<br />
dispensary<br />
Test<br />
cost<br />
(PLN)<br />
25 5 8,05 7,54 238,95<br />
I 131 whole-body sc<strong>in</strong>tigraphy <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> thyroid cancer amounts 238.95 PLN, and<br />
<strong>the</strong> cost <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> amounts 4,515.00 PLN.<br />
<strong>PET</strong>-<strong>CT</strong> is a <strong>in</strong>dividually contracted service <strong>of</strong> 420 po<strong>in</strong>ts <strong>in</strong> pric<strong>in</strong>g. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz, <strong>the</strong><br />
sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Table 63.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
Test cost [PLN]<br />
95
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
420 10,75<br />
4 515,00<br />
The <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> thyroid cancer amounts 335.55 PLN, and<br />
<strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong> public payer’s perspective – amounts 4,515.00 PLN.<br />
9.2. RESULTS<br />
The follow<strong>in</strong>g table conta<strong>in</strong>s results <strong>of</strong> <strong>the</strong> comparative cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
vs computed tomography <strong>in</strong> <strong>the</strong> thyroid cancer recurrences detection.<br />
Table 64.<br />
Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs I 131 whole-body sc<strong>in</strong>tigraphy <strong>in</strong> <strong>the</strong> thyroid cancer recurrence<br />
diagnostics<br />
Procedure <strong>Cost</strong> per one patient [PLN] <strong>Cost</strong> difference [PLN]<br />
<strong>PET</strong>-<strong>CT</strong> 4 515,00<br />
I 131 whole-body sc<strong>in</strong>tigraphy 238,95<br />
4 276,05<br />
The results <strong>of</strong> <strong>analysis</strong> show that thyroid cancer recurrence diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more<br />
expensive than I 131 whole-body sc<strong>in</strong>tigraphy.<br />
96
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
10. PANCREATIC CANCER – COST-COMPARISON ANALYSIS –<br />
<strong>PET</strong>-<strong>CT</strong> VS <strong>CT</strong><br />
This <strong>in</strong>dication was <strong>in</strong>itially qualified to <strong>the</strong> <strong>analysis</strong>, because <strong>of</strong> <strong>the</strong> statistically significant<br />
differences <strong>in</strong> diagnostic <strong>effect</strong>iveness parameters <strong>of</strong> <strong>the</strong> compared imag<strong>in</strong>g techniques<br />
(see: “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with<br />
diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic<br />
diagnostics - epidemiological and cl<strong>in</strong>ical part”). Data from <strong>the</strong> follow<strong>in</strong>g publications were<br />
used <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>analysis</strong>:<br />
1. He<strong>in</strong>rich S, Goerres GW, Schafer M, Sagmeister M, Bauerfe<strong>in</strong>d P, Pestalozzi BC, Hany TF,<br />
von Schul<strong>the</strong>ss GK, Clavien P. Positron emission tomography/computed tomography<br />
<strong>in</strong>fluences on <strong>the</strong> management <strong>of</strong> resectable pancreatic cancer and its cost<strong>effect</strong>iveness.<br />
Ann Surg 2005; Vol. 242 (2): pp 235-243.<br />
Due to <strong>the</strong> lack <strong>of</strong> difference <strong>of</strong> cl<strong>in</strong>ical <strong>effect</strong>s <strong>analysis</strong> with ICER ratio <strong>in</strong> case <strong>of</strong> <strong>in</strong>fluence<br />
<strong>of</strong> cl<strong>in</strong>ical advancement assessment <strong>of</strong> pancreatic cancer before surgical procedure on<br />
applied treatment strategy was not performed <strong>in</strong> <strong>the</strong> model.<br />
Available data concerned <strong>effect</strong>iveness <strong>of</strong> diagnostic methods <strong>in</strong> assess<strong>in</strong>g cl<strong>in</strong>ical<br />
advancement <strong>of</strong> <strong>the</strong> cancer and its <strong>in</strong>fluence on applied treatment. In spite <strong>of</strong> statistically<br />
significant differences <strong>in</strong> parameters describ<strong>in</strong>g efficacy <strong>of</strong> diagnostics performed us<strong>in</strong>g<br />
compared methods, due to <strong>the</strong> specific results configuration <strong>in</strong> <strong>the</strong> model <strong>the</strong>re were not any<br />
differences <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>effect</strong> (patients survival). Lack <strong>of</strong> <strong>the</strong> difference <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>effect</strong><br />
makes perform<strong>in</strong>g <strong>analysis</strong>, utiliz<strong>in</strong>g ICER ratio, impossible.<br />
Patients qualify<strong>in</strong>g to <strong>the</strong> radical treatment, that were not treated due to <strong>the</strong> diagnostic<br />
error should have shortened life expectancy, accord<strong>in</strong>gly to <strong>the</strong> op<strong>in</strong>ion <strong>of</strong> experts from <strong>the</strong><br />
Maria Skłodowska-Curie Memorial Institute Center <strong>of</strong> Oncology <strong>in</strong> Warsaw. Because<br />
accord<strong>in</strong>gly to data from publication (see reference above) none <strong>of</strong> <strong>the</strong> compared<br />
diagnostic methods falsely revealed unresectability <strong>of</strong> <strong>the</strong> pancreatic cancer, <strong>in</strong> case<br />
reference procedure revealed a possibility <strong>of</strong> apply<strong>in</strong>g surgical treatment, <strong>the</strong>re was not any<br />
difference <strong>of</strong> cl<strong>in</strong>ical <strong>effect</strong>s between compared methods.<br />
The cost-comparison <strong>analysis</strong> was performed and its results are presented below.<br />
10.1. COSTS CALCULATION<br />
In a study concern<strong>in</strong>g <strong>the</strong> pancreatic cancer diagnostics, <strong>the</strong> hybrid <strong>PET</strong>-<strong>CT</strong> was compared<br />
to <strong>the</strong> computed tomography (<strong>CT</strong>). Computed tomography is and out-patient diagnostic<br />
97
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
service, co-f<strong>in</strong>anced (ASDW), that amounts 42 po<strong>in</strong>ts – 37 po<strong>in</strong>ts are refunded by <strong>the</strong> National<br />
Health Fund and <strong>the</strong> 5 po<strong>in</strong>ts are covered by a physician referr<strong>in</strong>g to <strong>the</strong> procedure<br />
(“Catalogue <strong>of</strong> <strong>the</strong> co-f<strong>in</strong>anced out-patient diagnostic procedures ranges (ASDW)”. Annex<br />
No. 1b to <strong>the</strong> <strong>in</strong>formational materials AOS). Referrer covers <strong>the</strong> cost <strong>of</strong> performed procedure,<br />
accord<strong>in</strong>g to <strong>the</strong> negotiated price <strong>of</strong> <strong>the</strong> po<strong>in</strong>t. The National Health Fund covers <strong>the</strong> cost <strong>of</strong><br />
<strong>the</strong> co-f<strong>in</strong>anced diagnostic procedure, accord<strong>in</strong>gly to <strong>the</strong> prices <strong>of</strong> <strong>the</strong> po<strong>in</strong>t, negotiated by:<br />
health care provider perform<strong>in</strong>g <strong>the</strong> procedure and by <strong>the</strong> referrer.<br />
It was assumed that referr<strong>in</strong>g center is <strong>the</strong> oncologic dispensary. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> <strong>the</strong> oncologic dispensary, calculated on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all<br />
such <strong>in</strong>stitutions <strong>in</strong> Poland, bounded with <strong>the</strong> NHF contract (data <strong>in</strong> <strong>the</strong> annex), amounts 7.54<br />
PLN.<br />
Similarly, <strong>the</strong> average po<strong>in</strong>t price <strong>in</strong> <strong>the</strong> computed tomography laboratory, calculated on a<br />
basis <strong>of</strong> <strong>the</strong> po<strong>in</strong>t price <strong>in</strong> all computed tomography laboratories bounded with <strong>the</strong> National<br />
Health Fund contract <strong>in</strong> Poland, amounts 8.05 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>CT</strong> service from <strong>the</strong> ASDW catalogue,<br />
toge<strong>the</strong>r with its cost calculation.<br />
Table 65.<br />
Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis <strong>of</strong> <strong>the</strong> ASDW catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
Computed<br />
tomography<br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
<strong>CT</strong>: One or more parts<br />
<strong>of</strong> <strong>the</strong> body<br />
exam<strong>in</strong>ation - with<br />
contrast media<br />
5.03.00.0000029<br />
NHF refund<br />
Po<strong>in</strong>ts value<br />
Referrer’s<br />
surcharge<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
<strong>CT</strong><br />
laboratory Oncologic<br />
dispensary<br />
37 5 8,05 7,54<br />
<strong>PET</strong>-<strong>CT</strong> is a <strong>in</strong>dividually contracted service <strong>of</strong> 420 po<strong>in</strong>ts <strong>in</strong> pric<strong>in</strong>g. The average price <strong>of</strong> <strong>the</strong><br />
settlement po<strong>in</strong>t <strong>in</strong> positron emission tomography <strong>in</strong> <strong>the</strong> Center <strong>of</strong> Oncology <strong>in</strong> Bydgoszcz, <strong>the</strong><br />
sole provider perform<strong>in</strong>g <strong>PET</strong> exam<strong>in</strong>ation, amounts 10.75 PLN.<br />
The follow<strong>in</strong>g table shows <strong>the</strong> characteristics <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> service from <strong>the</strong> <strong>in</strong>dividually<br />
contracted services catalogue, toge<strong>the</strong>r with <strong>the</strong> unitary cost calculation.<br />
Test<br />
cost<br />
(PLN)<br />
335,55<br />
98
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 66.<br />
Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> <strong>in</strong>dividually contracted services<br />
catalogue<br />
Type <strong>of</strong> <strong>the</strong><br />
diagnostic test<br />
<strong>PET</strong>-<strong>CT</strong><br />
(<strong>CT</strong>)<br />
Name and code <strong>of</strong><br />
<strong>the</strong> service<br />
Positron emission<br />
tomography (<strong>PET</strong>)<br />
5.10.00.0000042<br />
Po<strong>in</strong>ts value<br />
Average price <strong>of</strong> 1 po<strong>in</strong>t<br />
[PLN]<br />
420 10,75<br />
Test cost [PLN]<br />
4 515,00<br />
The average <strong>CT</strong> exam<strong>in</strong>ation cost <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> pancreatic cancer amounts<br />
335.55 PLN, and <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> exam<strong>in</strong>ation cost – from <strong>the</strong> public payer’s perspective – amounts<br />
4,515.00 PLN.<br />
10.2. RESULTS<br />
The follow<strong>in</strong>g table conta<strong>in</strong>s results <strong>of</strong> <strong>the</strong> comparative cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong><br />
vs computed tomography <strong>in</strong> <strong>the</strong> pancreatic cancer diagnostics.<br />
Table 67.<br />
Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> pancreatic cancer diagnostics<br />
Procedure <strong>Cost</strong> per one patient [PLN] <strong>Cost</strong> difference [PLN]<br />
<strong>PET</strong>-<strong>CT</strong> 4 515,00<br />
<strong>CT</strong> 335,55<br />
4 179,45<br />
The results <strong>of</strong> <strong>analysis</strong> show that pancreatic cancer diagnostics us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> is more<br />
expensive than computed tomography.<br />
99
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
11. COLON CANCER - NO ANALYSIS - <strong>PET</strong>-<strong>CT</strong> VS <strong>CT</strong><br />
This <strong>in</strong>dication was <strong>in</strong>itially qualified to <strong>the</strong> <strong>analysis</strong>, because <strong>the</strong>re was no data exclud<strong>in</strong>g<br />
existence <strong>of</strong> statistically significant difference <strong>in</strong> diagnostic <strong>effect</strong>iveness parameters <strong>of</strong> <strong>the</strong><br />
compared imag<strong>in</strong>g techniques (see: “Comparative cost – <strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron<br />
emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong> Poland from <strong>the</strong> public<br />
assets <strong>in</strong> <strong>the</strong> oncologic diagnostics - epidemiological and cl<strong>in</strong>ical part”). Data from <strong>the</strong><br />
follow<strong>in</strong>g publications were used <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical <strong>analysis</strong>:<br />
1. Veit P, Antoch G, Stergar H, Bockisch A, Forst<strong>in</strong>g M, Kuehl H. Detection <strong>of</strong> residual<br />
tumor after radi<strong>of</strong>requency ablation <strong>of</strong> liver metastasis with dual-modality <strong>PET</strong>-<strong>CT</strong>:<br />
Initial results. Eur Radiol 2006; Vol. 16 (1): pp 80–87.<br />
Due to <strong>the</strong> lack <strong>of</strong> possibility to utilize, <strong>in</strong> <strong>the</strong> <strong>analysis</strong> with ICER ratio, data concern<strong>in</strong>g<br />
diagnostic <strong>effect</strong>iveness <strong>of</strong> compared methods <strong>in</strong> <strong>the</strong> assessment <strong>of</strong> residual lesions after<br />
colon cancer liver metastases radio-frequency ablation (<strong>in</strong> case <strong>of</strong> contra<strong>in</strong>dications to<br />
remove <strong>the</strong> lesions surgically), <strong>the</strong> <strong>analysis</strong> with ICER ratio was not performed <strong>in</strong> this <strong>in</strong>dication.<br />
Available data concerned <strong>the</strong> <strong>effect</strong>iveness <strong>of</strong> diagnostic methods <strong>in</strong> <strong>the</strong> residual disease<br />
after ablation assessment. Presented results are counted on <strong>the</strong> quantity <strong>of</strong> lesions, <strong>the</strong>re are<br />
no results counted on <strong>the</strong> quantity <strong>of</strong> patients. Due to that reason <strong>in</strong>formation from <strong>the</strong> study<br />
could not be used <strong>in</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> model construction and cost comparison<br />
<strong>analysis</strong> is also impossible.<br />
100
12. DISCUSSION<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
In some <strong>in</strong>dications <strong>PET</strong>-<strong>CT</strong> is more <strong>effect</strong>ive and simultaneously more expensive diagnostic<br />
method than o<strong>the</strong>r compared techniques. The diagnostic efficacy differences <strong>of</strong> compared<br />
methods lead to differences <strong>of</strong> cl<strong>in</strong>ical efficacy and treatment costs.<br />
Accurate diagnostics <strong>of</strong> head and neck malignant neoplasms metastases produces<br />
sav<strong>in</strong>gs due to delay <strong>of</strong> <strong>in</strong>adequate <strong>the</strong>rapy. Radical treatment (surgical and radiological) <strong>of</strong><br />
patients with distant metastases only multiply costs, do not give better <strong>effect</strong>s. Patients<br />
without metastases, when good diagnosed, have a chance for radical treatment,<br />
<strong>in</strong>accurate diagnostics cause lost <strong>of</strong> this chance and impact on survival. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong>stead<br />
<strong>of</strong> <strong>CT</strong>, for 8,100.09 PLN, one life year will be ga<strong>in</strong>ed.<br />
Accurate early diagnostics <strong>of</strong> head and neck malignant neoplasms recurrences allows<br />
adequate, improv<strong>in</strong>g survival, treatment <strong>of</strong> patients with recurrence. In case <strong>of</strong> patients with<br />
no recurrence perform<strong>in</strong>g <strong>of</strong> accurate diagnostics save money, los<strong>in</strong>g on needless treatment<br />
when diagnose is <strong>in</strong>accurate. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, for 33,016.54 PLN, one life year will<br />
be ga<strong>in</strong>ed.<br />
Accurate diagnostics <strong>of</strong> unknown primary orig<strong>in</strong> <strong>of</strong> head and neck malignant neoplasms<br />
<strong>in</strong>crease survival. Inaccurate diagnose reduce chance for radical treatment. Patients without<br />
primary tumor, when good diagnosed, can avoid needless treatment, <strong>in</strong>accurate diagnostics<br />
cause rise <strong>of</strong> costs. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, for 38,322.77 PLN, one life year will be ga<strong>in</strong>ed.<br />
Accurate stag<strong>in</strong>g <strong>of</strong> non-small cell lung cancer <strong>in</strong>crease survival <strong>in</strong> case <strong>of</strong> low stage<br />
patients and reduce costs <strong>in</strong> case <strong>of</strong> high stage patients. Inaccurate diagnose reduce<br />
chance for radical treatment <strong>in</strong> case <strong>of</strong> low stage patients and produces cost <strong>of</strong> <strong>in</strong>adequate<br />
surgical treatment <strong>in</strong> case <strong>of</strong> high stage patients. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, for 152,862.22<br />
PLN, one life year will be ga<strong>in</strong>ed.<br />
In assessment <strong>of</strong> GIST response to imat<strong>in</strong>ib <strong>the</strong>rapy, accurate diagnose <strong>of</strong> response <strong>in</strong>crease<br />
survival. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, for 159,626.51 PLN, one life year will be ga<strong>in</strong>ed.<br />
Accurate diagnostics <strong>of</strong> primary tumor <strong>of</strong> unknown primary orig<strong>in</strong> malignant neoplasms<br />
<strong>in</strong>crease survival. Inaccurate diagnose reduce chance for radical treatment. Patients without<br />
primary tumor, when good diagnosed, can avoid needless treatment, <strong>in</strong>accurate diagnostics<br />
cause rise <strong>of</strong> costs. Us<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> <strong>in</strong>stead <strong>of</strong> <strong>CT</strong>, for 14,125.67 PLN, one life year will be ga<strong>in</strong>ed.<br />
101
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
For some medical <strong>in</strong>dications primarily <strong>in</strong>cluded <strong>in</strong>to cost-<strong>effect</strong>iveness <strong>analysis</strong>, due to<br />
<strong>in</strong>sufficient data, were performed only cost comparison <strong>analysis</strong>. <strong>PET</strong>-<strong>CT</strong> is more expensive<br />
than o<strong>the</strong>r diagnostic methods. In one case no <strong>analysis</strong> was possible.<br />
Accuracy <strong>of</strong> diagnostic tests data used <strong>in</strong> <strong>analysis</strong> came from “Comparative cost – <strong>effect</strong><br />
<strong>analysis</strong> <strong>of</strong> <strong>the</strong> positron emission tomography <strong>PET</strong>-<strong>CT</strong> with diagnostic technologies f<strong>in</strong>anced <strong>in</strong><br />
Poland from <strong>the</strong> public assets <strong>in</strong> <strong>the</strong> oncologic diagnostics - epidemiological and cl<strong>in</strong>ical<br />
part”. This situation produces limitations due to search strategy <strong>of</strong> <strong>the</strong> report. Only<br />
randomized controlled trials were <strong>in</strong>cluded <strong>in</strong>to report, what guarantee high reliability <strong>of</strong> data<br />
but also limit quantity <strong>of</strong> available <strong>in</strong>formation.<br />
Survival data was assumed by experts on basis <strong>of</strong> literature and <strong>the</strong>ir own cl<strong>in</strong>ical<br />
experiences. Generally <strong>the</strong> problem is assumption <strong>of</strong> <strong>in</strong>accurate diagnostics <strong>in</strong>fluence on<br />
patients’ survival, so due to lack <strong>of</strong> better sources <strong>of</strong> data, particularly for polish medical<br />
circumstances, experts’ estimations were used.<br />
Sensitivity <strong>analysis</strong> revealed stability <strong>of</strong> <strong>the</strong> performed calculations for <strong>the</strong> described<br />
alterations <strong>of</strong> parameters, characteriz<strong>in</strong>g compared diagnostic schemes. Survival data had<br />
<strong>the</strong> most critical impact on results.<br />
102
13. LIST OF TABLES<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 1. Service characteristics and <strong>the</strong> head computed tomography cost calculation, on a<br />
basis <strong>of</strong> <strong>the</strong> ASDW catalogue ................................................................................................10<br />
Table 2. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................10<br />
Table 3. <strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies, from <strong>the</strong> NHF services catalogue, used <strong>in</strong> head and<br />
neck malignant neoplasms treatment.................................................................................10<br />
Table 4. <strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected radio<strong>the</strong>rapeutic procedures used <strong>in</strong> head and neck malignant<br />
neoplasms treatment, on a basis <strong>of</strong> <strong>the</strong> NHF services catalogue ..................................11<br />
Table 5. Surgical procedures used <strong>in</strong> head and neck malignant neoplasms metastases<br />
treatment ...................................................................................................................................11<br />
Table 6. List <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
comparison <strong>in</strong> <strong>the</strong> head and neck malignant neoplasms metastases diagnostics...13<br />
Table 7. List <strong>of</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> results <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck<br />
malignant neoplasm metastases diagnostics ....................................................................14<br />
Table 8. Results <strong>of</strong> <strong>analysis</strong> obta<strong>in</strong>ed us<strong>in</strong>g <strong>the</strong> Monte Carlo simulation method for 100,000<br />
patients, compar<strong>in</strong>g <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm<br />
metastases diagnostics ...........................................................................................................15<br />
Table 9. Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm<br />
metastases diagnostics ...........................................................................................................16<br />
Table 10. Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis<br />
<strong>of</strong> <strong>the</strong> ASDW catalogue ..........................................................................................................20<br />
Table 11. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................21<br />
Table 12. <strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies, from <strong>the</strong> NHF services catalogue, used <strong>in</strong> head and<br />
neck malignant neoplasms treatment.................................................................................21<br />
Table 13. <strong>Cost</strong>s <strong>of</strong> selected radio<strong>the</strong>rapeutic procedures used <strong>in</strong> head and neck malignant<br />
neoplasms treatment, on a basis <strong>of</strong> NHF's catalogue <strong>of</strong> services. .................................22<br />
Table 14. Surgical procedures used <strong>in</strong> head and neck malignant neoplasms treatment .........22<br />
Table 15. List <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
comparison <strong>in</strong> <strong>the</strong> head and neck malignant neoplasms recurrences diagnostics..23<br />
Table 16. Results <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck<br />
malignant neoplasm recurrence diagnostics.....................................................................25<br />
Table 17. Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong><br />
<strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm recurrence diagnostics ....26<br />
Table 18. Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm<br />
recurrences diagnostics ..........................................................................................................27<br />
Table 19. Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis<br />
<strong>of</strong> <strong>the</strong> ASDW catalogue ..........................................................................................................31<br />
Table 20. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................32<br />
Table 21. <strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services.........................32<br />
103
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 22. <strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services.........................33<br />
Table 23. Surgical procedures used <strong>in</strong> head and neck malignant neoplasms treatment .........33<br />
Table 24. List <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
comparison <strong>in</strong> <strong>the</strong> primary tumor <strong>of</strong> head and neck malignant neoplasms<br />
diagnostics.................................................................................................................................34<br />
Table 25. Results <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck<br />
malignant neoplasm primary tumor diagnostics ...............................................................36<br />
Table 26. Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong><br />
<strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm primary tumor diagnostics<br />
......................................................................................................................................................37<br />
Table 27. Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> head and neck malignant neoplasm<br />
primary tumor diagnostics ......................................................................................................38<br />
Table 28. Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis<br />
<strong>of</strong> <strong>the</strong> ASDW catalogue ..........................................................................................................46<br />
Table 29. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................47<br />
Table 30. <strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected chemo<strong>the</strong>rapy regimens from <strong>the</strong> NHF’s catalogue <strong>of</strong> services<br />
......................................................................................................................................................47<br />
Table 31. <strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services.........................48<br />
Table 32. Selected surgical procedures used <strong>in</strong> lung cancer treatment.......................................48<br />
Table 33. Comparison <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<br />
<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical advancement <strong>of</strong> non-small cell lung cancer<br />
diagnostics.................................................................................................................................48<br />
Table 34. Results <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> non-small cell lung<br />
cancer cl<strong>in</strong>ical advancement assessment .........................................................................52<br />
Table 35. Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong><br />
<strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> non-small cell lung cancer cl<strong>in</strong>ical advancement<br />
......................................................................................................................................................53<br />
Table 36. Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> comparison <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> non-small cell lung cancer<br />
cl<strong>in</strong>ical advancement assessment .......................................................................................55<br />
Table 37. Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis<br />
<strong>of</strong> <strong>the</strong> ASDW catalogue ..........................................................................................................63<br />
Table 38. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................63<br />
Table 39. Active substance used <strong>in</strong> GIST treatment and its po<strong>in</strong>t value on a basis <strong>of</strong> <strong>the</strong><br />
<strong>the</strong>rapeutic programs catalogue.........................................................................................63<br />
Table 40. Comparison <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<br />
<strong>CT</strong> vs <strong>CT</strong> comparison <strong>in</strong> <strong>the</strong> assessment <strong>of</strong> GIST response to imat<strong>in</strong>ib treatment ........64<br />
Table 41. List <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> results concern<strong>in</strong>g comparison <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
<strong>in</strong> <strong>the</strong> assessment <strong>of</strong> <strong>the</strong> GIST treatment with imat<strong>in</strong>ib response ....................................65<br />
Table 42. Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong><br />
<strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> GIST response to imat<strong>in</strong>ib assessment ................................................66<br />
Table 43. Sensitivity <strong>analysis</strong> <strong>of</strong> comparison <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> assessment <strong>of</strong> GIST response<br />
to imat<strong>in</strong>ib treatment...............................................................................................................67<br />
104
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 44. Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis<br />
<strong>of</strong> <strong>the</strong> ASDW catalogue ..........................................................................................................74<br />
Table 45. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................74<br />
Table 46. <strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services.........................74<br />
Table 47. <strong>Cost</strong>s <strong>of</strong> <strong>the</strong> selected <strong>the</strong>rapies from <strong>the</strong> NHF’s catalogue <strong>of</strong> services.........................75<br />
Table 48. Surgical procedures used <strong>in</strong> unknown primary orig<strong>in</strong> neoplasms treatment...............75<br />
Table 49. List <strong>of</strong> model parameters with values used <strong>in</strong> <strong>the</strong> sensitivity <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
comparison <strong>in</strong> <strong>the</strong> primary tumor <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms diagnostics<br />
......................................................................................................................................................76<br />
Table 50. Results <strong>of</strong> <strong>the</strong> cost-<strong>effect</strong>iveness <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> unknown primary<br />
orig<strong>in</strong> neoplasm primary tumor diagnostics........................................................................79<br />
Table 51. Results <strong>of</strong> <strong>the</strong> Monte Carlo simulation <strong>analysis</strong> for 100,000 patients, compar<strong>in</strong>g <strong>the</strong><br />
<strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> primary tumor diagnostics <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms<br />
......................................................................................................................................................80<br />
Table 52. Sensitivity <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> unknown primary orig<strong>in</strong> neoplasms<br />
primary tumor diagnostics ......................................................................................................81<br />
Table 53. Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis<br />
<strong>of</strong> <strong>the</strong> ASDW catalogue ..........................................................................................................85<br />
Table 54. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................85<br />
Table 55. Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> ovarian cancer<br />
recurrence diagnostics............................................................................................................86<br />
Table 56. Service characteristics and <strong>the</strong> computed tomography and transoesophageal<br />
ultrasound-guided f<strong>in</strong>e needle aspiration biopsy (EUS-FNA) costs calculations..........88<br />
Table 57. Service characteristics and <strong>PET</strong>-<strong>CT</strong> cost calculation.........................................................89<br />
Table 58. Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> vs EUS-FNA <strong>in</strong> <strong>the</strong><br />
oesophageal cancer cl<strong>in</strong>ical advancement assessment, after neoadiuvant<br />
treatment ...................................................................................................................................90<br />
Table 59. Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis<br />
<strong>of</strong> <strong>the</strong> ASDW catalogue ..........................................................................................................92<br />
Table 60. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................92<br />
Table 61. Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> lymphomas<br />
recurrence diagnostics............................................................................................................93<br />
Table 62. Service characteristics and <strong>the</strong> whole-body sc<strong>in</strong>tigraphy cost calculation, on a basis<br />
<strong>of</strong> <strong>the</strong> ASDW catalogue ..........................................................................................................95<br />
Table 63. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................95<br />
Table 64. Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs I131 whole-body<br />
sc<strong>in</strong>tigraphy <strong>in</strong> <strong>the</strong> thyroid cancer recurrence diagnostics.............................................96<br />
Table 65. Service characteristics and <strong>the</strong> computed tomography cost calculation, on a basis<br />
<strong>of</strong> <strong>the</strong> ASDW catalogue ..........................................................................................................98<br />
Table 66. Service characteristics and <strong>PET</strong>-<strong>CT</strong> diagnostics calculation, on <strong>the</strong> basis <strong>of</strong> <strong>the</strong><br />
<strong>in</strong>dividually contracted services catalogue .......................................................................99<br />
105
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Table 67. Results <strong>of</strong> <strong>the</strong> cost-comparison <strong>analysis</strong> <strong>of</strong> <strong>the</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> <strong>in</strong> <strong>the</strong> pancreatic cancer<br />
diagnostics.................................................................................................................................99<br />
106
14. LIST OF FIGURES<br />
<strong>Cost</strong>-<strong>effect</strong> <strong>analysis</strong> <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> <strong>system</strong>.<br />
<strong>Analysis</strong> <strong>in</strong> <strong>the</strong> cl<strong>in</strong>ical aspect, us<strong>in</strong>g ICER ratio<br />
Figure 1. Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> <strong>the</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
comparison, used <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> head and neck malignant neoplasms<br />
(legend – table 6).......................................................................................................................9<br />
Figure 2. Decision tree present<strong>in</strong>g model used <strong>in</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison, <strong>in</strong><br />
<strong>the</strong> head and neck malignant neoplasms recurrences detection (legend - table 15)<br />
......................................................................................................................................................19<br />
Figure 3. Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison,<br />
used <strong>in</strong> <strong>the</strong> diagnostics <strong>of</strong> <strong>the</strong> head and neck malignant neoplasms primary tumor<br />
(legend – table 24)...................................................................................................................30<br />
Figure 4. Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> <strong>the</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
comparison, used <strong>in</strong> <strong>the</strong> non-small cell lung cancer cl<strong>in</strong>ical advancement<br />
assessment<br />
(legend – table 33)...................................................................................................................45<br />
Figure 5. Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> <strong>the</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong><br />
comparison, used to assess <strong>the</strong> response for imat<strong>in</strong>ib treatment <strong>of</strong> GIST (legend –<br />
table 40) .....................................................................................................................................62<br />
Figure 6. Decision tree show<strong>in</strong>g <strong>the</strong> model used <strong>in</strong> calculations <strong>of</strong> <strong>PET</strong>-<strong>CT</strong> vs <strong>CT</strong> comparison,<br />
used <strong>in</strong> <strong>the</strong> primary tumor diagnostics <strong>in</strong> case <strong>of</strong> unknown primary orig<strong>in</strong> neoplasms<br />
(legend – table 49)...................................................................................................................73<br />
107