A systematic review of the effectiveness of adalimumab

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168 Appendix 8 TABLE 82 Brennan et al., 2004 160 (cont’d) Uncertainty around Uncertainty in the results was expressed in terms of conducting scenario-based one-way cost-effectiveness expressed sensitivity analyses to investigate the impact of alternative scenarios for the key model parameter values Appropriateness of method Yes dealing with uncertainty around cost effectiveness Sensitivity analysis One-way sensitivity analysis (scenario-based) was undertaken: analysis as described above was performed, in addition to analyses of changes to the response rate of etanercept, changes to HAQ scores and changes to mortality estimates Modelling inputs and Yes techniques appropriate Authors’ conclusions Etanercept is cost-effective compared with non-biological agents. NICE recognised it as costeffective and recommended its availability for use in patients who have failed at least two DMARDs previously. This model was used to inform the decision taken by NICE TABLE 83 Kobelt et al., 2004 163 Authors Kobelt, Eberhardt, Geborek Date 2004 Type of economic evaluation Cost–utility analyses Country of origin Sweden, France Currency used Euros Year to which costs apply 2002 Perspective Societal Study population Patients with RA who failed to respond to at least two DMARDs, including MTX, in Sweden Intervention 1 Etanercept or infliximab Intervention 2 Baseline level (failed at least two DMARDs, including MTX) Source of effectiveness data Follow-up of patients from a cohort treated with etanercept or infliximab Clinical outcomes measured The Swedish version of the HAQ, DAS28 and the EQ-5D were used during the first year of and methods of valuation used follow-up Cost data handled Yes. Direct costs were based on unit cost data from Lund (the largest centre used in the appropriately trial), and a Swedish pharmaceutical lexicon. Indirect costs were estimated by the human capital method using the average annual gross salary. Short-term sick leave was based on the number of days of absence and the loss of productivity was based on the proportion of fulltime work of patients aged >65 years Modelling summary Not undertaken Outcome measures used in economic evaluations Mean utilities per year and QALY gained with 1 year of treatment, based on EQ-5D data Direction of result with NE quadrant. After 3 months of treatment: €43,500 per QALY; after 6 weeks treatment: appropriate quadrant location €36,900 per QALY Statistical analysis for patient-level stochastic data Yes Appropriateness of Yes: means and standard deviations reported. No bootstrapping was undertaken, and this statistical analysis may have been appropriate given the small data set Uncertainty around cost-effectiveness expressed Not undertaken Appropriateness of method dealing with uncertainty around cost effectiveness NA continued
TABLE 83 Kobelt et al., 2004 163 (cont’d) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Sensitivity analysis Sensitivity analysis was undertaken on all 160 patients: all patients who began one of the treatments. The main economic evaluation was based on those patients who continued to receive TNF inhibitor treatment for at least 12 months and had complete data (116 patients) Modelling inputs and NA techniques appropriate Authors’ conclusions Cost-effectiveness ratios are within the generally accepted threshold of €50,000, but need to be confirmed with larger samples. Assuming that the improvements occurred within 3 months after treatment, the cost per QALY is €36,900. Sensitivity analysis, including all 160 patients, gave an estimated cost per QALY of €53,600. The cost per QALY increases for patient groups with less severe disease TABLE 84 Chiou et al., 2004 170 Authors Chiou, Choi, Reyes Date 2004 Type of economic evaluation Cost–utility analysis Country of origin USA Currency used US dollars Year to which costs apply 2003 Perspective Healthcare (payers) Study population Patients with moderate to severe RA who were deemed candidates for the following biological monotherapies and combination therapies Intervention 1 Adalimumab Intervention 2 Anakinra (reference case for monotherapy) Intervention 3 Etanercept Intervention 4 Adalimumab + MTX Intervention 5 Anakinra + MTX Intervention 6 Etanercept + MTX Intervention 7 Infliximab + MTX Source of effectiveness data Effectiveness data were sourced from a review of previously published RCTs. The results of the review were presented to an expert panel of rheumatologists who selected the relevant clinical trials based on similar patient inclusion criteria and baseline characteristics. ACR response criteria: ACR20, ACR50 and ACR70 were used in the model. Probabilities for achieving ACR20, ACR50 and ACR70 for each treatment strategy were sourced from published literature. The absolute response rates from the clinical trial data with the most comparable patient population characteristics and study design were used as input data for the model. SAE rates were also sourced from clinical trial data. The same expert panel classified the adverse events, associated with each treatment strategy, into severity levels and estimated the corresponding medical resource use associated with each. SAEs were categorised as mild, moderate or severe. The highest frequency reported in a study was used to assign the probability within each severity classification. Probabilities for being in each health state were determined by the product of the probability of achieving each ACR response criterion and for developing different levels of SAEs, assuming that the probabilities for achieving each were independent Cost data handled Yes. Drug costs were based on US average wholesale prices. Healthcare resource costs for appropriately medication, injection and infusion, monitoring and management of SAEs were obtained from the 2003 American Medical Association Current Procedural Terminology (CPT codes) codebook, the 2003 Medicare Reimbursement Fee Schedule and the Medstat Diagnosis Related Group (DRG) Guide. The costs of complications were estimated as follows: a mild complication included the cost of one visit every 6 months and associated laboratory tests, the cost of a moderate complication included that of a mild complication plus the cost of antibiotics, and the cost of a severe complication included the cost of hospitalisation for pneumonia or sepsis continued 169
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A systematic review of the effectiv
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A systematic review of the effectiv
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Objectives: This report reviews the
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Glossary and list of abbreviations
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viii Glossary and list of abbreviat
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Background Rheumatoid arthritis (RA
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increased risk of serious infection
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Summary RA is a common, chronic, in
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(IL-2) and interleukin-6 (IL-6), pr
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Assessment of response to DMARDs Re
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combination with methotrexate or al
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disease between clinic appointments
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14 Effectiveness in juvenile arthri
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16 Effectiveness adalimumab plus me
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18 Effectiveness Monoclonal Antibod
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20 TABLE 1 Description of included
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22 TABLE 2 Quality of included RCTs
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24 Effectiveness change in modified
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26 Effectiveness TABLE 4 Meta-analy
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28 Effectiveness Review: Adalimumab
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30 Effectiveness Review: Adalimumab
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32 TABLE 6 Effectiveness Descriptio
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34 TABLE 6 Effectiveness Descriptio
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36 TABLE 7 Effectiveness Quality of
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38 Effectiveness etanercept trials.
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40 Effectiveness TABLE 9 Summary of
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42 Effectiveness Review: Etanercept
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54 Effectiveness TABLE 11 Summary o
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56 TABLE 12 Description of included
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58 TABLE 13 Quality of included RCT
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60 Effectiveness per week and escal
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62 Effectiveness significant advant
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64 Effectiveness Review: Infliximab
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66 Effectiveness Review: Infliximab
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68 Effectiveness FIGURE 44 Malignan
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70 TABLE 17 Effectiveness Summary o
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Summary of review of existing econo
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TABLE 20 Summary of published ICERs
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TABLE 21 Published etanercept econo
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TABLE 23 Published economic analyse
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TABLE 25 Treatment sequences: adali
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management of RA, i.e. 1st and 2nd
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To estimate the long-term consequen
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TABLE 32 TNF inhibitors as last act
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TABLE 34 Basic structure of the mod
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een quit on grounds of toxicity, ad
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TABLE 39 Strategy set: adalimumab a
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TABLE 43 Beta distributions for HAQ
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TABLE 44 Early cessation of DMARDs:
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TABLE 46 Unit costs for tests and v
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following properties, according to
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TABLE 52 Base case: TNF inhibitors
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TABLE 54 Base case: TNF inhibitors
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TABLE 59 Third TNF inhibitor follow
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TABLE 65 Sensitivity analyses: TNF
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TABLE 67 Sensitivity analyses: TNF
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The substantial economic impact of
Page 133 and 134: Summary Effectiveness: principal fi
Page 135 and 136: inhibitors, although the incrementa
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Page 139: Adalimumab, etanercept and inflixim
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TABLE 153 Variation 15: TNF inhibit
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No. 3 Screening for sickle cell dis
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No. 25 A rapid and systematic revie
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246 Health Technology Assessment Pr
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A systematic review of the effectiveness of adalimumab

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