prvi bosansko-hercegovački i drugi jadranski kongres ...

FOLIA MEDICA FACULTATIS MEDICINAE UNIVERSITATIS SARAEVIENSIS 

Journal of Medical Faculty University of Sarajevo, Bosnia&Herzegovina 

Contents 

2012;47(1-suppl) 

PODIUM LECTURES 

APPLIED PHARMACOECONOMICS: HOW PHARMACOECONOMICS CAN BE APPLIED 

TO SUPPORT DECISIONS BY DIFFERENT STAKEHOLDERS IN HEALTH CARE? 

Zoltán Kaló, Dinko Vitezić . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 

THE ROLE OF PHARMACOECONOMICS AND HEALTH TECHNOLOGY ASSESSMENT 

IN ENSURING PATIETNS’ EQUITY RIGHTS 

Faris Gavrankapetanović . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 

ENSURING EQUITY AND AVAILABILITY OF HEALTHCARE REGARDING PATIENTS’ 

RIGHT ON EFFECTIVE, SAFE, QUALITY AND AVAILABLE ESSENTIAL DRUGS IN 

FEDERATION OF BOSNIA AND HERZEGOVINA 

Rusmir Mesihović, Sanja Ćustović . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 

MEDICINES POLICY IN THE REPUBLIC OF SRPSKA – AVAILABILITY AND EQUALITY 

Vanda Marković Peković . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 

REIMBURSEMENT OF EXPENSIVE HOSPITAL DRUGS IN SLOVENIA 

Jurij Fürst, Rozeta Hafner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 

VALUE BASED PRICING – ONGOING HTA REFORM IN THE UK 

Petr Hajek . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 

TRANSFERABILITY OF NICE RECOMMENDATIONS TO LOWER INCOME COUNTRIES: 

THE CASE OF ONCOLOGY DRUGS 

Zoltán Kaló . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 

ADJUSTMENT AND IMPLEMENTATION OF CROATIAN P&R MODEL 

Bruna Buble, Tonči Buble, Vesna Bačić Vrca, Dinko Vitezić . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 

HEALTH TECHNOLOGY ASSESSMENT IN SERBIA 

Vlad Zah . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 

PRICING POLICY IN MACEDONIA – OVERVIEW ANALYSIS 

Marija Gulija, Gordana Damjanovska . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 

THE BLOCKADE OF SCIATIC NERVE AND POSSIBLE CONSEQUENCES 

OF INTRANEURAL INJECTIONS 

Livio Garattini, Katelijne van de Vooren . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 

IMPACT OF THERAPEUTIC CLASS REFERENCING (JUMBO GROUPS) AS A METHOD 

OF GOVERNMENT COST CONTAINMENT MEASURES ON PRESCRIBING BEHAVIOURS 

AND CONSEQUENT QUALITY OF PATIENT CARE 

Sani Pogorilić, Jelka Drašković, Slobodanka Bolanča . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 

SHOWING THE USE OF DRUGS IN THE CLINICAL CENTER OF MONTENEGRO 

AND COMPARISON WITH MODERN PHARMACOTHERAPEUTIC RECOMMENDATIONS 

Mirjana Jovanović-Đurašković, Olivera Prodanović . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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COMPARISON OF DRUGS CONSUMPTION IN TWO CROATIAN COUNTY 

GENERAL HOSPITALS 

Aleksandar Knežević, Mila Basioli, Hana Kalinić Grgorinić . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 

BURDEN OF COMMUNITY ACQUIRED PNEUMONIA 

IN CENTRAL EUROPEAN COUNTRIES 

Ales Tichopad, C . Roberts, A . Skoczynska, I . Gembula, K . Jahnz-Rozyk . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 

THE ROLE OF HEALTH AUTHORITIES IN PROMOTION OF RATIONAL USE 

OF ANTIBIOTICS 

Merjem Hadjihamza . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 

PHARMACOECONOMIC ANALYSIS COMPARING THE USE OF CIPROFLOXACIN 

AND METRONIDAZOLE VERSUS ERTAPENEM IN PROPHYLAXIS OF MAYOR SURGICAL 

PROCEDURES AT THE UNIVERSITY HOSPITAL REBRO 

Ivana Čegec, Robert Likic, Ksenija Makar Ausperger, Viktorija Erdeljic, Matea Radacic Aumiler, 

Danica Juricic Nahal, Luka Bielen, Iva Kraljickovic, Igor Francetic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 

IMPACT OF CEFTRIAXONE DE-RESTRICTION ON THE COST OF ANTIBIOTIC TREATMENT 

Srecko Marusic, Vesna Bacic-Vrca, Jasenka Skrlin, Lado Uglesic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 

IMPACT OF THE PHARMA ECONOMIC ACT ON DIFFUSION OF INNOVATION, 

REDUCTION OF COSTS AND PATIENTS’ EQUITY IN THE HUNGARIAN PRESCRIPTION 

DRUG MARKET 

Rok Hren . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 

ETHICS AS A RISING ISSUE FOR TARGETED THERAPIES: THE METASTATIC 

COLORECTAL EXAMPLE 

Livio Garattini, Katelijne van de Vooren . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 

IMPLEMENTATION OF BIOLOGICAL THERAPY AND SURGERY IN THE TREATMENT 

OF METASTATIC COLORECTAL CANCER: ARE THE COSTS JUSTIFIED? 

Renata Dobrila-Dintinjana, Dinko Vitezić . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 

THE ROLE OF CYTOLOGY IN DETECTION OF SMALL BREAST CANCER – EXPERIENCE 

OF UNIVERSITY HOSPITAL FOR TUMOURS, ZAGREB (COST BENEFIT?) 

Vesna Ramljak, Iva Bobuš-Kelčec, Merdita Agai, Ljiljana Mayer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 

COMPARATIVE ANALYSIS OF PATIENT ACCESS TO TARGETED THERAPIES FOR 

METASTATIC RENAL CELL CARCINOMA (MRCC) IN SELECTED CEE COUNTRIES 

Jasmina Krehić, Novka Agić, Vedrana Raguž . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 

PHARMACOECONOMICS IN PREDICTIVE MEDICINE 

Josip Čulig, Marcel Leppee, Nikolina Skaron-Jakobović . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 

THE ECONOMIC COST ANALYSIS OF THE IMPLEMENTATION OF CENTRALIZED 

PHARMACY UNIT FOR ANTINEOPLASTIC DRUGS WITH RESPECT TO THE PREMISES, 

EQUIPMENT AND TECHNICAL STAFF UNDER THE SUPERVISION OF ONCOLOGY 

PHARMACIST 

Vesna Pavlica, Damir Vrbanec, Velemir Danko Vrdoljak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 

MUSCULOSKELETAL DISORDER - THEIR IMPACT ON WORK ABILITY AND SOCIETAL 

COSTS IN POLAND 

Magdalena Wladysiuk, Ksenia Zhelthoukhova, Stephen Bevan, Mateusz Haldas . . . . . . . . . . . . . . . . . 36

CASE STUDY IN TRANSPLANTATION AND IMMUNOSUPPRESSANT THERAPY 

IN MACEDONIA, THREE YEAR FOLLOW UP 

Stevce Acevski, Zoran Sterjev, Vladimir Indov . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 

RARE DISEASES OR DISORDERS, ORPHAN DRUGS AND PATIENTS EQUITY RIGHTS 

Jasmina Krehić, Senka Mesihović Dinarević . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 

STEREOLOGICAL ANALYSIS OF TERMINAL VILLI OF HUMAN PLACENTAS 

ASSOCIATED WITH EPH GESTOSIS 

Dinko Vitezić . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 

TRENDS IN THE UTILIZATION OF CARDIOVASCULAR DRUGS IN CROATIA DURING 

THE PERIOD 2007-2010 

Viola Macolić-Šarinić, Pero Draganić, Josip Čulig, Marcel Leppée, Marinko Bilušić, Saša Žeželić . . . 40 

COMPARATIVE ANALYSIS OF CARDIOVASCULAR DRUGS UTILISATION IN GENERAL 

HOSPITAL AND CLINICAL CENTER IN CROATIA AND BOSNIA AND HERZEGOVINA 

Mirza Dilić, Aleksandar Knežević, Sanja Sarić-Kužina, Anesa Eminović . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 

DIFFERENTIAL DIAGNOSIS OF CLEAR CELL TUMORS 

Nenad Vanis, Rusmir Mesihović, Aida Saray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 

MODELLING THE EUROPEAN BURDEN OF DISEASE ASSOCIATED MALNUTRITION 

András Inotai, Mark Nuijten, Eric Roth, Refaat Hegazi, Zoltán Kaló . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 

FROM MORISKY TO HILL-BONE: MEASUREMENT OF ADHERENCE TO MEDICATION 

Josip Čulig, Marcel Leppee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 

THE COST OF DIABETES MELLITUS IN MACEDONIA 

Donka Pankov, Zoran Sterjev, Ljubica Suturkova . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 

COST-EFFECTIVENESS OF INTERVENTIONS TO CONTROL DIABETES MELLITUS 

AND PREVENT COMPLICATIONS 

Terezija Šarić, Tamara Poljičanin, Željko Metelko . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 

SYMPTOMATIC THERAPY FOR COLD AND FLU – MACEDONIAN CASE 2011 

Stevce Acevski, Vladimir Indov, Zoran Sterjev, Rubin Zareski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 

ECONOMIC EVALUATION OF DECREASING PERSISTANT HYPERTENSION WITH RENAL 

DENERVATION DEVICE CUTTING COSTS OF HYPERTENSION COMMORBIDITIES IN 

UPCOMING CROATIAN PRACTICE 

Vanesa Benković, Ranko Stevanović, Ana Ivičević, Marko Matulović, Bojan Jelaković . . . . . . . . . . . . . 48 

CODIFFICATION AS A METHOD IN RESEARCH ON ANIMAL MODELS 

IN PHARMACOECONOMICAL EFFICIENCY 

Iris Broman . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 

THE ROLE OF PHARMACOECONOMICS IN MEDICINES REIMBURSEMENT 

DECISION-MAKING IN BOSNIA AND HERZEGOVINA 

Tarik Čatić, Igor Martinović, Begler Begović . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 

EVALUATION OF UTILIZATION OF OLD VERSUS NEWER ANTIEPILEPTIC DRUGS 

IN REPUBLIC OF MACEDONIA 

Bojana Danilovska, Zoran Sterjev, Ljubica Suturkova . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 

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DEMENTIA- CAN FORGETFULNESS BE SIGNIFICANT SOCIAL ISSUE? 

Vedran Đukić, Nenad Bogdanović . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 

COMPARISON OF COST EFFECTIVENES OF TOTAL HIP AND KNEE ENDOPROTESIS 

WITH AND WITHOUT PROLONGED THROMBOEMBOLIC PROPHYLAXIS 

Ismet Gavrankapetanović, Faris Gavrankapetanović, Mehmed Jamakosmanović, 

Slobodanka Bolanča . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 

HUMAN PAPILLOMAVIRUS VACCINATION OF BOYS: COST-EFFECTIVENESS ANALYSIS 

Rok Hren . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 

COST-EFFECTIVENESS OF COMBINED TREATMENT OF METFORMIN 

AND FENOFIBRATE ON RETINOPATHY PROGRESSION 

Rok Hren, Radomir Cerovic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 

EVALUATION OF COST-SAVING OF CLOPIDOGREL PHARMACOGENETIC TESTING 

IN PATIENT WITH ATHEROTROMBOTIC DISORDERS FROM R. MACEDONIA 

Aleksandra Kapedanovska Nestorovska, Zorica Naumovska, Zoran Sterjev, 

Aleksandar Dimovski, Ljubica Suturkova . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 

INFLUENCE OF INCREASED LINEZOLID UTILISATION ON DEVELOPMENT 

OF ANTIMICROBIAL RESISTANCE TO LINEZOLID 

Aleksandar Knežević, Sanja Sarić-Kužina, Ivanka Matas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 

INSTITUTIONAL AND NORMATIVE FRAMEWORK OF DRUG CONTROL COSTS 

IN THE REPUBLIC OF MACEDONIA 

Kostadinka Kozareva, Ana Petrovska Angelovska . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 

ANTIDIABETIC DRUG EXPENDITURE IN BOSNIA AND HERZEGOVINA - 2009/2010 

Jasmina Krehic, Zelija Velija Asimi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 

COST EFFECTIVENESS OF RENAL SYMPATHETIC DENERVATION IN PATIENTS WITH 

REFRACTORY HYPERTENSION: DECISION MODELLING OF APPLICABILITY FOR 

CROATIAN HEALTH CARE 

Robert Likić, Ksenija Makar Aušperger, Viktorija Erdeljić, Matea Radačić Aumiler, 

Igor Francetić, Bojan Jelaković . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 

THE FREQUENCY OF ADMINISTRATION OF ANTIPSYCHOTICS, ANXIOLYTICS 

AND ANTIDEPRESSANTS: DESCRIPTION STUDY 

Svjetlana Loga-Zec, Damir Celik, Faris Gavrankapetanović, Jasmina Krehić, 

Mensura Aščerić, Nedžad Mulabegović . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 

FINANCIAL IMPACT OF IMPORTED UNAPPROVED DRUGS ON THE HOSPITAL 

BUDGET: EXAMPLE OF THE CHILDREN’S HOSPITAL OF THE UNIVERSITY 

HOSPITAL CENTRE RIJEKA, CROATIA 

Vesna Rosović-Bazijanac, Jasenka Mršić-Pelčić, Dinko Vitezić . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 

MALNUTRITION IN CROATIA – WHERE ARE WE TODAY AND WHY SHOULD 

WE INCLUDE SOCIETAL PERSPECTIVE IN MEASURING “BURDEN OF ILLNESS“? 

Ranko Stevanović, Vanesa Benković, Ana Ivičević, Ivana Kolčić, Irena Rojnić Palavra . . . . . . . . . . . . . . 63

PRVI BOSANSKO-HERCEGOVAČKI I DRUGI 

JADRANSKI KONGRES FARMAKOEKONOMIKE 

I ISTRAŽIVANJA ISHODA LIJEČENJA 

ORGANIZATORI KONGRESA 

Udruženje za zdravstvenu ekonomiku i 

farmakoekonomska istraživanja u Bosni 

i Hercegovini u saradnji sa Sekcijom za 

farmakoekonomiku i istraživanje ishoda 

liječenja Hrvatskog društva za kliničku 

farmakologiju, terapiju i Udruženjem za 

farmakoekonomiku i istraživanje ishoda u BIH i 

ISPOR Macedonia chapter. 

PREDSJEDNICI KONGRESA 

Faris Gavrankapetanović 

Dinko Vitezić 

SEKRETARI KONGRESA 

Slobodanka Bolanča 

Tarik Ćatić 

RIZNIČAR 

Sakib Katana 

Sanja Sarić-Kužina 

ORGANIZACIJSKI ODBOR (predsjedavajući) 

Novka Agić (predsjedavajuća) 

Mahmut Đapo (predsjedavajući) 

Nataša Grubiša (predsjedavajuća) 

ORGANIZACIJSKI ODBOR (članovi) 

Aldina Ahmetagić (Bosna i Hercegovina) 

Tonći Buble (Hrvatska) 

Viktorija Erdeljić (Hrvatska) 

Jurij Fürst (Slovenija) 

Svjetlana Loga Zec (Bosna i Hercegovina) 

Zoltan Kalo (Mađarska) 

Jasmina Krehić (Bosna i Hercegovina) 

Viola Macolić-Šarinić (Hrvatska) 

Filipa Markotić (Bosna i Hercegovina) 

Lilijana Oruč (Bosna i Hercegovina) 

Zoran Sterjev (Makedonija) 

Svjetlana Stoisavljević Šatara 

(Bosna i Hercegovina) 

Nedim Tvrtković (Bosna i Hercegovina) 

NAUČNI ODBOR (predsjedavajući) 

Igor Francetić 

Rusmir Mesihović 

Nedžad Mulabegović 

Ranko Škrbić 

NAUČNI ODBOR (članovi) 

Jugoslav Bagatin (Hrvatska) 

Elmir Čičkušić (Bosna i Hercegovina) 

Livio Garattini (Italija) 

Mirjana Huić (Hrvatska) 

Aleksandar Knežević (Hrvatska) 

Ante Kvesić (Bosna i Hercegovina) 

Bakir Mehić (Bosna i Hercegovina) 

Ljerka Ostojić (Bosna i Hercegovina) 

Zoran Riđanović (Bosna i Hercegovina) 

Ljubica Suturkova (Makedonija) 

Aziz Šunje (Bosna i Hercegovina) 

Veljko Trivun (Bosna i Hercegovina) 

Vlad Zah (Srbija) 

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FOLIA MEDICA FACULTATIS MEDICINAE UNIVERSITATIS SARAEVIENSIS 

Journal of Medical Faculty University of Sarajevo, Bosnia&Herzegovina 

Editor-in-Chief 

Nedžad Mulabegović 

Execute Editor 

Maida Rakanović Todić 

Editorial Board 

Jasminko Huskić 

Damir Aganović 

Amela Begić 

Slavica Ibrulj 

Semra Čavaljuga 

Nermin Sarajlić 

Almira Hadžović Džuvo 

Lejla Burnazović Ristić 

Radivoj Jadrić 

Lectorised by 

Dubravko Vaniček 

Technical Editor and Print 

SaVart Sarajevo 

DTP 

Narcis Pozderac 

Adress of the Editorial board: 

71000 Sarajevo, Čekaluša 90 

Bosnia & Herzegovina 

Phone: 00387 33 226 472 

Fax: 00387 33 203 670 

Published by 

Faculty of Medicine, 

University of Sarajevo 

www.mf.unsa.ba/folia 

ISSN 0352-9630 

EBSCO Publishing (EP) USA 

http://www.epnet.com 

Printed on acid-free paper

Dear Colleagues and friends 

On behaf of Scientific Committee of the Association of Health Economics and Pharmacoeconomic 

Research in Bosnia and Herzegovina in cooperation with the Section for 

Pharmacoeconomi¬cs and Outcomes Research of the Croatian Society for Clinical Pharmacology 

and Therapeutics and the Association for Pharmacoeconomics and Outcomes Research 

inBIH, 

it gives me a great pleasure to welcome you to the First Bosnian-Herzegovinian and Second 

Adriatic Congress of the Pharmacoeconomics and Outcomes Research. 

We are sure that the plenary lectures, poster presentations and panel discussions will enrich 

the scientific atmospfere in the Farmacoeconomic and Health Economic field. 

It is our pleasure to list all scientific abstracts in the supllement of 

“FOLIA MEDICA FACULTATIS MEDICINAE UNIVERSITATIS SARAEVIENSIS”, indexed 

Journal of Medical Faculty University of Sarajevo, Bosnia&Herzegovina. 

Warm regards, 

Professor Nedžad Mulabegović 

Editor in Chief 

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Poštovane kolegice i kolege, dragi prijatelji, 

Srdačno Vas pozdravljamo i želimo Vam dobrodošlicu u ime organizatora Prvog bosanskohercegovačkog 

i drugog jadranskog kongresa farmakoekonomike i istraživanja ishoda liječenja 

koji se održava u Sarajevu od 24. do 26. aprila 2012. godine. 

Organizatori Kongresa, Udruženje za zdravstvenu ekonomiku i farmakoekonomska 

istraživanja u Bosni i Hercegovini u suradnji sa Sekcijom za farmakoekonomiku i istraživanje 

ishoda liječenja Hrvatskog društva za kliničku farmakologiju i terapiju i Udruženjem za farmakoekonomiku 

i ispitivanje ishoda u BiH, ove su se godine odlučili za vodilju skupa postaviti 

ulogu farmakoekonomike u osiguranju prava jednakosti bolesnika na liječenje. 

Nadamo se da će ovaj Kongres nastaviti tradiciju unapređenja rada na regionalnom nivou, 

što se već i potvrdilo na osnovu velikog interesovanja sudionika iz zemalja regije, te da će biti 

još uspješniji od prethodnog koji je održan u Rovinju, aprila mjeseca 2011. godine. Kongres 

će obuhvatiti kroz predavanja, poster prezentacije i organizaciju radionice raznovrsne teme iz 

područja razvoja politike zdravstvene zaštite, politike formiranja cijena i uvrštavanja lijekova 

na pozitivnu listu, ispitivanja komparativne učinkovitosti i kliničkih ishoda, kontrole potrošnje 

lijekova i istraživanja ekonomskih ishoda, procjene zdravstvenih tehnologija te mnoge druge, 

sa posebnim osvrtom na krajnje korisnike, odnosno naše pacijente. Vjerujemo da će dodatnu 

korist u okviru Kongresa predstavljati i organizirana radionica pod naslovom Primijenjena farmakoekonomika 

u kojoj će biti prikazani principi na osnovu kojih farmakoekonomika postaje 

neizostavan alat i pomoć pri donošenju odluka na različitim nivoima u području zdravstvene 

zaštite. 

Kao predavači i voditelji radionica, uz domaće, sudjelovaće i priznati međunarodni stručnjaci. 

Raduje nas i činjenica da će Kongres okupiti stručnjake i sve zainteresirane koji se u regiji 

i šire bave farmakoekonomikom, od akademske zajednice, kroz udruženja pa sve do regulatornih 

tijela i industrije, uz dodatno nastojanje promoviranja principa integrativnog pristupa 

farmakoekonomici, njihovog implementiranja i informiranja šire javnosti. 

Zahvaljujemo se Vama kao sudionicima i svima koji su pomogli u realizaciji ovog Kongresa 

i želimo Vam ugodan boravak u Sarajevu! 

Uz najbolje želje, 

Prof. dr. sc. Faris Gavrankapetanović Prof. dr. sc. Dinko Vitezić 

Predsjednik Udruženja za zdravstvenu Predsjednik Sekcije za farmakoekonomiku i 

ekonomiku i farmakoekonomska istraživanje ishoda liječenja Hrvatskog 

istraživanja u BIH društva za kliničku farmakologiju i terapiju

Dear colleagues, dear friends, 

We cordially welcome you on behalf of the Organizers of the First Bosnian-Herzegovinian 

and Second Adriatic Congress of the Pharmacoeconomics and Outcomes Research to be held 

in Sarajevo on 24 to 26 April 2012. 

Organizers of the Congress, Association of Health Economics and Pharmacoeconomic 

Research in Bosnia and Herzegovina in cooperation with the Section for Pharmacoeconomics 

and Outcomes Research of the Croatian Society for Clinical Pharmacology and Therapeutics 

and the Association for Pharmacoeconomics and Outcomes Research inBIH, this year, decided 

to set up The role of farmacoconomics in ensuring patients’ equity rights as a topic guide. 

We hope that this Congress will continue the tradition of advancing this work at regional 

level, which is already confirmed on the basis of the great interest of participants from countries 

of the region, and that this Congress will be even more successful than the previous one held in 

Rovinj, April, 2011. The Congress will cover the lectures, poster presentations and workshops 

on various topics in health policy development, pricing policies and the inclusion of drugs on 

the positive drug lists, a comparative study of efficiency and clinical outcomes, control of drug 

consumption and economic outcomes research, health technology assessment, and many others, 

with special reference to end-users - our patients. We believe that the added benefit of this 

Congress will be a workshop titled Applied pharmacoeconomics which will show the principles 

on which pharmacoeconomics is becoming an indispensable tool and aid in decision making 

at various levels in the field of healthcare. 

Distinguished international experts will, together with our experts, participate as speakers 

and workshop leaders. We are delighted by the fact that the Congress will bring together 

experts and all interested professionals dealing with pharmacoeconomics in the region and 

beyond, from the academic community, the associations up to the regulatory authorities and 

industry, with further efforts to promote the principles of integrative approach to pharmacoeconomics, 

implementation of these principles and informing the general public. 

We do thank you as participants as well as everyone who helped in realization of this Congress. 

Wish you a pleasant stay in Sarajevo! 

With best wishes, 

Prof. Faris Gavrankapetanović, MD, PhD Prof. Dinko Vitezić, MD, PhD 

President, Association for Health Economics and President, Section for Pharmacoeconomics 

Pharmacoeconomic Research in Bosnia and and Outcomes Research,Croatian Society for 

Herzegovina Clinical Pharmacology and Therapeutics 

9

PRE-CONGRESS TRAINING COURSE 

Applied pharmacoeconomics: How pharmacoeconomics can be applied to 

support decisions by different stakeholders in health care? 

Zoltán Kaló 1 , Dinko Vitezić 2 

1 Eötvös Loránd University; Syreon Research 

Institute, Budapest, Hungary 

2 University of Rijeka, School of Medicine and Rijeka 

University Hospital Center, Rijeka, Croatia 

There is increasing need for improved evidence 

base of decisions in all different areas of decisionmaking 

in health care. A high-quality economic 

evaluation should provide decision-makers with 

useful, relevant, and timely information. Stakeholders 

both in public and private sectors apply 

pharmacoeconomic methods to make better 

decisions. Economic evaluations can quantify 

costs and consequences of different scenarios 

based on the best available scientific evidence, 

and can even take into account the uncertainty 

related to key assumptions. 

In the public sector economic evaluations are 

used to justify the basic drug benefit package. 

In more and more countries analysis of costeffectiveness 

and budget impact is mandated 

prior to pricing and reimbursement decisions 

of new pharmaceuticals. For reimbursement 

and formulary listing purposes, manufacturers 

need to convince payers that the drug results in 

considerable health benefit in real world; its costeffectiveness 

ratio does not exceed the threshold 

accepted by the society, and its financing is affordable, 

fits into the budget. 

Risk sharing agreements are based on health 

economic principles. Confidential pricing agreements 

in lower income countries can be applied 

to adjust the price of medicines to local purchasing 

power without influencing the published exfactory 

price and so the accessibility of patients 

to these drugs in other countries. Introduction 

of outcome based risk-sharing schemes can be a 

major advancement in the drug reimbursement 

strategy of payers. These schemes can help to 

reduce the medical uncertainty in coverage decisions 

for valuable innovative healthcare tech- 

10 Proofreading and translations are in the explicit responsibility of the authors. 

nologies. Coverage with evidence development 

can fill in the evidence gap especially for orphan 

drugs. 

Economic evaluation, as part of health technology 

assessment is applicable to review full 

therapeutic areas with significant budget impact 

(e.g. diabetes, oncology, autoimmune diseases), 

including the revision of therapeutic guidelines 

and financing protocols and delisting of previously 

reimbursed pharmaceuticals. 

In the private sector pharmacoeconomic evaluations 

are applied in pharmaceutical R&D and 

marketing decisions. Economically justifiable 

price based the target product profile is essential 

input variable in the net present value calculation 

for go-no go, business development and 

licensing decisions. The need for cost-effectiveness 

evidence is taken into account in defining 

the optimal ex-factory price of new medicines. 

Pharmaceutical R&D faces the need for a new 

type of strategy: evidence base for registration 

and reimbursement has to be created at high scientific 

standards. This is a difficult task, as compliance 

with the different requirements needs 

different approaches. Evidences for registration 

have to be achieved with cheap, quick and lowrisk 

clinical programme, because R&D resources 

are limited, and due to the capped patent protection 

period, a shorter clinical development phase 

results in a longer return phase. Simple clinical 

trials with suboptimal comparators support 

these objectives. Evidences for reimbursement 

and formulary listing require another approach; 

innovators should prove in real-world situation 

that their new product is worth public financing 

against the best and most widely used alternative

procedures. These clinical trials are longer and 

more expensive, as sample size has to be greater 

to power these studies adequately. In addition to 

efficacy and safety end points, a new type of data 

must be collected alongside clinical trials, which 

increases the risks and the expected budget of 

the R&D programme. 

Before the launch of new medicines, a global 

health economic dossier is prepared in parallel 

with the adaptation of results to most important 

countries or markets. Local health economists 

prepare country-specific health economic 

dossiers in order to obtain reimbursement and 

formulary listing in all countries. Health economists 

are also involved into the planning and 

pharmacoeconomic assessment of major phase 

IV and observational studies to extend the economic 

evidence base in a constantly changing 

clinical and economic environment. 

As a consequence of increased utilization of 

pharmacoeconomic evaluations in health care 

decisions, there is growing demand for trained 

health economists. Short courses and post-graduate 

university training can fulfill this demand in 

Central- Eastern European countries. 

Proofreading and translations are in the explicit responsibility of the authors. 

11

PL 1.1. 

The role of pharmacoeconomics and health technology assessment in 

ensuring patietns’ equity rights 

Faris Gavrankapetanović 

Clinical Center University of Sarajevo, Bosnia and 

HerzegovinaE-mail: bakic@medfak.ni.ac.rs 

Life expectancy and mortality rates in Bosnia 

and Herzegovina are comparable to countries 

in region, but still lower than EU average and 

far away from benchmark EU countries known 

to have the best healthcare outcomes (France, 

Spain and Italy). Available healthcare resources 

are insufficient to meet national healthcare 

needs thus different health economic tools for 

the rational use of available resources based on 

efficiency and patient equity, in the first place 

pharmacoeconomics and health technology assessment, 

are of highest importance and priority,. 

There is also a wide variability in the speed 

and magnitude with which valuable innovative 

medicines and other new technologies become 

available to patients; and then further variability 

in uptake of medicines and between disease areas. 

Cantonal and Entity Governments are facing 

additional difficulties and challenges during the 

current financial situation. For that reason, now 

more than ever policymakers across the country 

need to work together so that all patients are able 

to receive the appropriate medical care. We must 

create the right regulatory and legal framework 


in B&H and shift public mindset from healthcare 

cost to healthcare value as well as set appropriate 

strategies with clear disease priorities in line with 

local epidemiology and mortality data. A formal 

process of using evidence to evaluate the clinical 

efficacy/effectiveness, the cost-effectiveness, and 

the broader impact of health technologies on 

patients and the health care system is needed to 

enhance the functioning of the health care system 

as a whole and to incorporate the interests 

of patients, health care professionals, payers and 

policy makers and manufacturers in such process. 

Because good health is basic human aspiration, 

patients should be empowered to make informed 

choices about access, allocation of funding 

and assessments of healthcare value. 

In conclusion, decision making in healthcare 

is a very complex process requiring simultaneous 

consideration of number of factors, among 

which pharmacoeconomics and health technology 

assessment are the most important for ensuring 

patient equity rights in healthcare systems 

with limited funding.

Ensuring equity and availability of healthcare regarding patients’ right on 

effective, safe, quality and available essential drugs in Federation of Bosnia 

and Herzegovina 

Rusmir Mesihović, Sanja Ćustović 

Ministry of Health of Federation Bosnia and 

Herzegovina, Sarajevo, Bosnia and Herzegovina 

Endeavoring to find mechanisms of ensuring the 

basic package of health insurance for all the citizens 

in Federation of Bosnia and Herzegovina 

as a part of socially sensitive government plan, 

Federal minister of health brings the Decision of 

the essential drug list, meaning drugs which are 

necessary for providing health insurance in accordance 

with the standards of obligatory health 

insurance in Federation of Bosnia and Herzegovina 

(Official Gazette of the Federation BiH 

no. 75/11) with revised prices. The new essential 

drug list consists of list A (100% reimbursement) 

with 140 different generic drug names, and list 

B (different reimbursement) which consists of 

85 generic drug names. The decision became effective 

on 10 November 2011, and cantons were 

obliged to adjust the positive cantonal drug lists 


PL 2.1. 

with the Federal essential drug list within 60 

days of the day when the Decision became effective, 

but in accordance with the Article 9 of the 

Federal Decision, that date has been prolonged, 

so the full implementation is expected by the end 

of August, 2012. In order to ensure cost-effective 

drugs, according to the Decision the prices of 

drugs from the positive lists which are higher of 

those determined by the Federal Decision will 

go down to the level of prices determined by the 

Decision, while the prices which are the same or 

lower remain the same provided that those drugs 

fulfill the general and specific criteria of the item 

VII of the Federal Decision. Further efforts will 

be made on implementation of pharmacoeconomic 

techniques as well as health technology 

assessment. 

13

PL 2.2. 

Medicines Policy in the Republic of Srpska – availability and equality 

Vanda Marković Peković 

Ministry of Health and Social Welfare 

Goal: To present Medicines Policy in the Republic 

of Srpska 

Materials and Methods: The legislation and 

available documents concerning health care system 

were used to evaluate the activities regarding 

availability of the medicines. 

Result. Prime objectives in the area of public 

healthcare in the Republic of Srpska are defined 

as preservation and improvement of public 

health, prolonged life expectancy and improvement 

of health related quality of life, amelioration 

of differences in health care availability and 

utilization, constant upgrade of quality and economic 

viability of health services and insurance 

against health related financial risks. 

Medicines are only one component in the maintenance 

and restoration of the health of communities 

and individuals, and are segment in the 

prevention, diagnosis and treatment of diseases. 

If used appropriately, medicines have the potential 

to relieve suffering and restore health, which 

is why they are placed amongst top priorities in 

every health system; otherwise, they waste resources, 

fail to achieve the purpose of their use 


and lead to financial consequences for the society 

as a whole. National Medicines Policy (NMP) 

as a political and professional document was 

adopted in 2006 by the Government. NMP is 

harmonized with the WHO policy and provides 

for a framework for the coordination of activities 

of all stakeholders in the area of medicines. 

The overall objective of NMP is to ensure that 

the whole population has access to effective, safe 

and quality medicines and that these are used in 

a rational and cost-effective manner. The overall 

objective shall be fulfilled through legislation 

and organization, quality, safety and efficacy of 

medicines, availability and rational use of medicines. 

The NMP is implemented through the 

document Medicines Strategy by 2012. 

Conclusion: Through the reform of the health 

system in general, much effort has been done in 

recent years to improve the pharmaceutical sector. 

Continuous, efficient and timely provision 

of quality, safe and efficient medicines to patient 

and health institutions in the Republic of Srpska 

ought to be guaranteed both now and in the future.

Reimbursement of expensive hospital drugs in Slovenia 

Jurij Fürst, Rozeta Hafner 

Health Insurance Institute of Slovenia, Slovenia 

Facing economic recession in 2010, Ministry of 

Health and Health Insurance Institute of Slovenia 

(ZZZS) have amended regulations on pricing 

and reimbursement of drugs. In the pricing 

regulation, more rigorous measures have been 

adopted. In the reimbursement regulation, pharmacoeconomic 

part has been renewed and a new 

reimbursement and financing model for hospital 

drugs has been enacted. A new drug list, called 

“hospital list” or “B-list”, was defined. 

The new B-list is reserved only for so-called expensive 

hospital drugs, defined by a price of 5 

000 EUR or more per patient per year. ZZZS follows 

the same procedure for both hospital and 

prescription drugs. Every drug is evaluated by 

both clinical criteria (these include therapeutic 

value and relative efficacy) and economic criteria 

(these include pharmacoeconomic and budget 

impact analysis). To reach an agreement between 

ZZZS and marketing authorisation holder about 

price is an important part of the procedure. 

There are no restrictions; ZZZS is allowed to 

sign any type of agreements. For the most expensive 

drugs, such as orphan enzyme replacement 

therapy, a triple agreement is prepared: the competent 

clinic defines clinical criteria for the inclusion 

of patients into the treatment, ZZZS and 

the pharmaceutical company agree on the way of 

financing. In some cases, the clinic has to obtain 


PL 2.3. 

a ZZZS’s consent for every patient. After that, 

ZZZS communicates with the pharmaceutical 

company to agree upon an additional discount. 

For most drugs, a mixed approach with a price 

discount and a material rebate or a financial cap 

is settled upon. Finally, ZZZS defines a list of 

hospitals/clinics to be included in the reimbursement 

scheme and a list of therapeutic indications 

to be covered. 

In order to enable ZZZS to control the use of 

B-list drugs, hospitals are required to prepare 

monthly reports providing data about all treated 

patients. These data should include age, sex, body 

surface area, doses, prices, etc. ZZZS reimburses 

hospitals for all B-list drugs on a monthly basis. 

The new B-list and a broad set of reimbursed 

prescription drugs (including low-molecular 

weight heparins, intravenous bisphosphonates, 

epoetins, drugs for multiple sclerosis, the whole 

spectrum of biological drugs for the treatment of 

rheumatic and other autoimmune diseases, and 

other high-priced drugs) enable high quality and 

effective hospital or ambulatory treatment for all 

patients without jeopardizing hospital budgets. 

A possible “side-effect” of such a “generous” approach 

is overuse of expensive drugs. Intensive 

cooperation with clinics/hospitals, as well as 

education and audits, may ensure a rational use 

of drugs. 

15

PL 2.4. 

Value Based Pricing – ongoing HTA reform in the UK 

Petr Hajek 

Pfizer Ltd., United Kingdom 

UK Government recognizes that there are significant 

failings within the system for drug pricing 

and access and is proposing reforms which 

it says will “provide NHS patients with better 

access to effective and innovative treatments at 

a price that secures value for the NHS”. These 

reforms are encompassed by three key new policies: 

1. Cancer Drugs Fund, an interim measure 

2011-2013 2. Value-Based Pricing (VBP) from 

2014 3. Transform the duties and responsibilities 

of NICE (National Institute for Health and Clinical 

Excellence), with the body taking on a more 

advisory role rather than as ‘gatekeeper’ to medicines. 

New structure of NICE will include Cost 

Effectiveness Analysis (as in current system) plus 

two Expert Panels: Burden of Illness Assessment 

and Innovation Assessment. New NICE structure 

is mentioned bellow: 


Basic price Willingness To Pay threshold reflecting 

benefits displaced elsewhere in NHS will be 

set. New thresholds will be introduced for 1. 

Higher price thresholds for medicines that tackle 

diseases where there is greater burden of illness, 

defined in terms of severity and unmet need. 2. 

Higher price threshold for therapeutic innovation 

3. Higher price threshold for medicines that 

demonstrate wider societal benefits. Under VBP, 

new medicines that offer significant health gain, 

address unmet need and offer therapeutic innovation 

will be advantaged…in the context of limited 

resources overall, those that do not, will do 

less well than under the current arrangements.

Transferability of NICE recommendations to lower income countries: the 

case of oncology drugs 

Zoltán Kaló 

Health Economics Research Centre, Eötvös Loránd 

University Syreon Research Insititute, Budapest, 

Hungary 

The health burden of malignancies is greater in 

Central-Eastern Europe than in Western Europe. 

Furthermore, these countries have more limited 

health care resources, and therefore transparent 

decision criteria for innovative cancer therapies, 

including the assessment of cost-effectiveness, 

are an absolute necessity. Transferability of good 

quality technology assessment reports, especially 

those prepared by NICE in the United Kingdom, 

could be highly beneficial to prevent duplication 

of efforts and save resources for local technology 

assessment. 

The presentation summarizes key factors influencing 

the transferability of NICE recommendations 

in oncology for policymakers and 

oncologists in Central-Eastern Europe without 

personal experience in health technology assessment. 

These factors include the incidence and 

prevalence of disease, disease progression, unit 


PL 3.1. 

costs, resource utilisation, unmet medical need, 

and consistency of NICE recommendations over 

time. 

In general, NICE recommendations are not 

transferable without adjustment of the analyses 

to local data. Even if the recommendation is positive, 

the conclusion can be still negative in lower 

income countries, mainly due to relative price 

differences and the significance of the local budget 

impact. Technologies with negative NICE 

recommendations can be still cost-effective in 

Central-Eastern Europe due to the worse health 

status and therefore the greater potential health 

gain of the targeted population. 

The appropriateness of reimbursement decisions 

must be improved in Central-Eastern Europe, 

but copying NICE recommendations without 

local adjustment may do more harm than good. 

17

PL 3.2. 

Adjustment and Implementation of Croatian P&R Model 

Bruna Buble 1 , Tonči Buble 2 , Vesna Bačić Vrca 1 , Dinko Vitezić 3 

1Faculty of Pharmacy and Biochemistry, Croatia 

2Belupo, Croatia 

3University Hospital Centre Rijeka and University of 

Rijeka Medical School, Croatia 

Actual Croatian “Pricing and Reimbursement” 

(P&R) model, introduced in 2001, has been 

changed several times until now. It provides an 

unique approach to the pricing of drugs from the 

basic drug list, financially covered by the Croatian 

Institute for Health Insurance - HZZO. 

In 2002 the administrative measure of exemption 

from co-payments, relating to over 50% of 

the insured persons, had the biggest impact on 

drug cost augmentation resulting in the annual 

growth rate of 25%. In 2007 the system, based 

on an external referring drug prices compared 

to the 3+2 reference countries (Italy, France, Slovenia 

+ Spain, Czech Republic), was completely 

defined and implemented. Internal reference 

system was set up by defining and implementing 

41 therapeutic groups for prescription drugs: 

drugs with the same or similar therapeutic effect, 

usually defined by the fourth level ATC classifi- 


cation of drugs. In the period from 2008 to 2010, 

consequent drug cost remained unchanged despite 

of the augmentation of 7 million prescriptions 

and introduction of a number of new drugs 

in the drug list. The insured persons can choose 

between free medicines from the basic drug list 

or more expensive alternative from the supplementary 

drug list by paying the difference in 

price. Drug producers can also choose between 

the reference price covered by basic insurance 

and the bigger price when the insured person 

pays difference in price. 

Using this model, it became unnecessary to relieve 

the insured of any co-payments (participation) 

while the options for the patient treatment 

remained at the same level. Croatian P&R model 

provides rational use of drugs and better control 

over the cost of drugs within the real possibilities 

of the budget.

Health Technology Assessment in Serbia 

Vlad Zah 

ISPOR Chapter Serbia 

This session reviews past and current approaches 

to Health Technology Assessment (HTA) in Serbia. 

It presents an overview of the product pricing 

and reimbursement processes for pharmaceuticals 

protected by patents. 

The new government regulations published in 

May 2011 do take into account necessity for the 

new innovative therapy, for the pharmacoeconomic 

indicators of justification for the new therapy application, 

as well as for the wholesale price of the 

new therapy. Over the last five years, there have 

been varying approaches utilized by the Serbian 

National Insurance Fund (RFZO) to regulate 

reimbursement policies and which products belong 

to which positive (reimbursement) list. 

As with any resources in a down turn, there has 

been not enough of health economists (among 

others) that could implement HTA effectively. 

This has been recognized by various institutions 

and the first training camps were open two years 

ago to facilitate this. 


PL 3.3. 

During this session attempts will be made to 

forecast further development of HTA in Serbia 

and its relationship to product pricing and reimbursement. 

Being financed predominantly by salaried workers 

and the respective level of salaries (70% of 

income), RFZO directly depends on the economic 

up/down turn. At the end of 2010, there 

were 1,626,581 pension beneficiaries, with a slight 

(1.4%) year-on-year increase. The ratio of total registered 

number of employees and total number of 

pensioners was 1.1 / 1.0. In a down turn, financial 

liquidity may become one of the issues. Namely, it 

can be difficult to collect funds in a timely fashion 

and in return this can cause shortages. 

During this session attempts will be made to 

forecast further development of HTA in Serbia 

and its relationship to product pricing and reimbursement. 

19

PL 3.4. 

Pricing Policy in Macedonia – overview analysis 

Marija Gulija, Gordana Damjanovska 

AD Dr. Panovski, Macedonia 

Defined systematized pricing policy in Macedonia 

was introduced through internal and external 

reference pricing system for drugs financially 

covered by the HIF. Recently, November 

2011, new Regulation for “ceiling” prices (unified 

prices of all drugs registered in the country) 

was enforced by the Bureau of Drugs, Ministry 

of Health. The purpose of this Regulation was to 

establish unification of ceiling prices of all drugs 

on the market in Macedonia. The Regulation 

aimed in controlling adjusted unified prices and 

stabilization of the pharmaceutical market. 

This overview analyses both methodologies developed, 

one from the HIF and the other from 

the Bureau of Drugs. This overview will try to 

provide information of the status of the prices 

of drugs on Macedonian pharmaceutical market, 

especially drugs financially covered by the 

HIF, through direct comparison of the prices of 

drugs, their adjustments and correlation. 

Performed analysis and comparison showed that 

prices of the drugs evaluated differ and are not 


completely adjusted. Regarding all evaluated 

prices of the positive list drugs, significant number 

have reference prices higher than the official 

unified price. This is due to the differences in the 

two methodologies used for calculation of the 

prices and they being not previously adjusted 

to each other. Having two completely different 

methodologies creates problems when the price 

has to be used for direct procurement. Thus, if 

the reference price is lower than unified price, 

than the drug is procured in accordance to the 

unified price. 

Therefore the system of reference prices established 

by the HIF becomes interfered. On the 

other hand, unified prices enabled setting of the 

prices of expensive drugs on the positive list of 

drugs for hospitals. If the country needs and decides 

to use this combined pricing policy, then 

previous adjustments of methodologies used for 

calculation of prices must be completely adapted.

THE BLOCKADE OF SCIATIC NERVE AND POSSIBLE 

CONSEQUENCES OF INTRANEURAL INJECTIONS 

Livio Garattini, Katelijne van de Vooren 

CESAV, Center for Health Economics, ‘Mario Negri’ 

Institute for Pharmacological Research, Italy 

Goal: The main objective of this comparative 

analysis was to assess the various co-payments 

on drugs applied in selected basket of EU western 

countries, either dealing with the problem of 

moral hazard or raising revenue. 

Materials and methods: We searched the internet 

to analyze the various co-payments for pharmaceuticals 

by patients in five West European countries; 

Germany, Italy, Norway, The Netherlands 

and the UK. Furthermore, we analyzed if and 

how patients with a lower income were compensated 

and protected from excessive expenses 

through exemptions. 

Results: Even though the situation varied substantially 

in the various countries, copayments 

were on average low in The Netherlands and the 

UK, while patients in Germany, Italy and Norway 

have to pay a higher share of out-of-pocket 

costs. As to the Netherlands, co-payments are 

caused by the difference between reference price 


PL 4.1. 

and actual price set by pharmaceutical companies. 

In the UK and in Italy the co-payment consist 

of a “lump sum” per prescription, although 

the situation is uneven throughout the countries 

(e.g. Scotland abolished co-payments, like some 

Italian regions), while in Germany and Norway 

a fixed proportion on prices has to be paid. In all 

countries regressive schemes are applied and patients 

with the lowest incomes and children are 

mostly exempted. 

Conclusion: Copayments exist in all the healthcare 

systems analyzed, doesn’t matter if they are 

taxation or insurance based. Even though evidence 

suggest that co-payments are inequitable, 

particularly in times of financial crisis, when 

budgets are tight while health care expenses are 

growing, increasing out-of-pocket costs is seen 

as a solution by health authorities to prevent 

overspending. 

21

PL 4.2. 

Impact of therapeutic class referencing (jumbo groups) as a method of 

Government cost containment measures on prescribing behaviours and 

consequent quality of patient care 

Sani Pogorilić, Jelka Drašković, Slobodanka Bolanča 

CARPC – Croatian Association of Research Based 

Pharmaceutical Companies 

Introduction: Therapeutic reference pricing 

(TRP) is a common cost containment measure 

used by payers to constrain rising pharmaceutical 

expenditure in a way that they are reimbursing 

the cost of certain medicine only up to a fixed 

maximum amount known as reference price. Patients 

are supposed to pay the difference between 

the reference price and the actual price. When 

such therapeutic classes are very broad and include 

both generics and patented medicines, the 

system is called jumbo group referencing and as 

such represents the most damaging form of reference 

pricing for both patients and innovative 

pharmaceutical industry. 

Materials and Methods: In this research, we have 

explored in detail historical pharmaceutical expenditure 

patterns using MIDAS, an IMS Health 

proprietary database, as well as a variety of secondary 

data sources. Croatian trends have been 

compared with those of a number of benchmark 

countries, categorized either as Peer Countries 

(Slovakia, Czech and Hungary) and Aspirational 

Countries known to have systems that have been 

ensuring excellent healthcare outcomes (France, 

Netherlands and Austria). 

Results: Jumbo groups account for around half 

of Croatian analysis market sales and two thirds 

of volume. A comparison of all jumbo grouped 

products in Croatia vs. use of those products 

in mentioned benchmark countries shows high 

consumption (higher volume usage) but low 

prices in Croatia. The relative distribution of 

products between basic and supplementary 


lists has remained static over time as well as the 

amount of co-pay at approximately 6% of total 

Rx sales, although the trend of slow increase of 

co-pay for original products has been observed, 

but not for generics. Drugs with and without copays 

have broadly similar prices, albeit low compared 

to other countries. This suggests the level 

of co-pay is generally low for drugs on supplementary 

list. Jumbo prices have been declining 

more than total prices although both are low vs. 

Benchmark countries. Prices of generics in jumbo 

groups are high compared to originators and 

other countries. 

Conclusion: This study confirms our hypothesis 

that prescribing habits of Croatian physicians 

are impacted by jumbo groups as they are 

significantly different from those observed in 

analyzed benchmark countries. This can negatively 

impact quality of treatments, especially for 

chronic patients, and undermine equal access to 

healthcare while it is most probably not achieving 

expected savings as it pulls generic prices up 

and originator prices down or shifting them to 

supplementary list with co-payment. Patients 

are thus oriented towards medicines which may 

not be adapted to their needs, resulting in poorer 

health outcomes. The best alternative to this unfavourable 

cost containment measure is the use 

of health technology assessment of medicines 

which will enable authorities to adequately reward 

healthcare and economic improvements 

brought by new products.

Showing the use of drugs in the Clinical Center of Montenegro and 

comparison with modern pharmacotherapeutic recommendations 

Mirjana Jovanović-Đurašković, Olivera Prodanović 

Agency for Medicines and Medical Devices of 

Montenegro, Montenegro 

Goal: Analysis of the use of drugs is an important 

segment of clinical pharmacotherapy 

because it may indicate the need and ways to 

rationalize therapy. The aim of this study is to 

analyze it, which will enable more realistic look 

at the relationship between therapeutic practice 

proposed by doctrinal views and modern therapeutic 

practice that is specifically implemented 

in the selected area. 

Materials and Methods: The data source was the 

Clinical Center of Montenegro Pharmacy report 

on issued drugs. The use of drugs was expressed 

as the number of defined daily doses (DDD) per 

1,000 bed days (BD). After obtaining the results 

shown in tables and charts, made a retrospective 

analysis, we used a descriptive-analytical 

method. 

Results: In the reporting period, the most common 

groups of drugs have proven to be remedies 


PL 4.3. 

for diseases of blood and blood-forming organs 

(25.52%), in second place were drugs for the digestive 

tract and metabolism (21.91%), in the 

third to the nervous system drugs (17.34%), and 

the fourth - systemic antiinfectives (12.01%). 

Conclusion: Research on consumption and use 

of drugs is extremely important because it may 

indicate the need for rationalization of therapy, 

as well as the direction in which we are to make, 

and also the education of doctors in prescribing 

medications adjusted to the modern principles 

of pharmacotherapy. This research pointed to 

certain changes in the use of drugs in the Clinical 

Center of Montenegro in 2010. compared to 

research done in 2004, and that is necessary to 

make additional educational efforts to establish 

more regular access to the choice of drugs. 

23

PL 4.4. 

Comparison of drugs consumption in two Croatian county general 

hospitals 

Aleksandar Knežević1, Mila Basioli1, Hana Kalinić Grgorinić2 

1 General hospital Zadar, Croatia 

2 General hospital Pula, Croatia 

Comparison of drugs consumption in two Croatian 

county general hospitals 

Goal of study: To analyze drug consumption in 

two Croatian county general hospitals similar in 

size, expected level of health care and patients 

catchment areas. 

Materials and methods: We analyzed total drug 

consumption in HRK and particulary first twenty 

drugs (Top 20) which share about 50% of total 

drug consumption during 5 years (2007th to 

2011th). 

Results: In 2007, General Hospital Pula spent 

on drugs 27.296.962 HRK of which the Top 20 

13.956.483 HRK (51%). In the same year, General 

Hospital Zadar spent on drugs 28.985.189 

HRK and 16.132.925 HRK for Top 20 (56%). 

Values for 2011: General Hospital Pula a total of 

HRK 33.272.104, and Top 20 18.456.304 HRK 

(55%), General Hospital Zadar total of HRK 

43.040.099 and Top 20 22.702.476 HRK (53%). 

During the observation period total drugs consumption 

in General Hospital Pula increased 


by 22%, and in Zadar General Hospital by 48%. 

Consumption of Top 20 increased by 32% in 

General Hospital Pula and in Zadar General 

Hospital by 41%. General Hospital Pula has a 

catchment area of about 160.000 inhabitants, 

506 beds contracted and 156.641 realised patient 

days, in 2011. Zadar General Hospital has 

a catchment area of about 200.000 inhabitants, 

483 contracted beds and 133.927 realised patient 

days in 2011. In 2011 General Hospital Zadar, 

although with 17%less realised patient days, 

spent 29% more for drugs in HRK. 

Conclusion: Differences between drug consumption 

in two compared hospitals can be explained 

by higher level of service in General Hospital 

Zadar or greater development of certain specialties, 

but also with more patients oriented toward 

that hospital. Of course, there is a possibility that 

the pharmacotherapy in General Hospital Pula is 

more rational than in Zadar. It certainly requires 

further investigation.

Burden of community acquired pneumonia in Central European countries 

Ales Tichopad 1 , C. Roberts 2 , A. Skoczynska 3 , I. Gembula 1 , K. Jahnz-Rozyk 4 

1 CEEOR, Prague, Czech Republic 

2 Pfizer, New York, USA 

3 National Medicines Institute, Warsaw, Poland 

4 Military Institute of Medicine, Warsaw, Poland 

Objectives: Older adults are in an increased risk 

of respiratory infections including community 

acquired pneumonia (CAP). The former socialistic 

countries of the central Europe form a 

unique region with specific health care and epidemiology 

characteristics, and where the local 

evidence on the underlying epidemiology in elderly 

is scarce. The objective of this study was to 

estimate the incidence and the case fatality rates 

(CFR) of CAP in adults ≥50 years of age in the 

Czech Republic (CR), Hungary (HU), Poland 

(PL) and Slovakia (SK). 

Methods: The incidence and the CFR for hospitalised 

CAP were estimated using the national 

surveillance systems (PL, CR, SK) and national 

insurance records (HU). National retrospective 

patient chart reviews (CZ, SK) were used to estimate 

the non-hospitalised CAP incidence as a 

portion of the hospitalised CAP. In PL we used 

national surveillance data and in HU the national 

insurance fund records to estimate outpatient 

CAP incidence. 

Results: Hospitalised CAP incidence per 100,000 

person years was 457 in CR, 879 in HU 879, 364 

in PL, and 524 in SK. The CFR per 100 cases of 

hospitalised CAP was estimated as 21 in CR; 20 

in SK; and 18 both in PL and HU. Non-hospitalised 

CAP incidence per 100,000 person years 


PL 5.1. 

was 710 in CR, 3551 in HU, 316 in PL, and 598 

in SK. Compared with adults 50-64 years of age, 

the incidence of hospitalised CAP were 2.3 fold 

higher in those 65-74, 5.2 fold higher in 75-84 

and 10.8 fold higher in those ≥85, manifesting 

an exponential trend. By contrast, the incidence 

of non-hospitalised CAP was generally flat or declining 

with age, representing a higher likelihood 

of hospitalisation with increasing age. The total 

number of hospitalisations and deaths in CR, 

HU, PL, and SK were 17,473 and 3,686; 23,652 

and 4,796; 35,895 and 7,325; 6,321 and 1,497) In 

Poland, for example, adults over 65 represent approximately 

14% of the study population, while 

they account for 80% of deaths from CAP). 

Conclusion: The morbidity and mortality of hospitalised 

CAP increases sharply with advancing 

age, signalling a likely increasing public health 

problem as the population ages over time. In HU, 

where the primary incidence data were provided 

by the national insurance fund, substantially 

larger incidence was calculated in both types of 

CAP with strikingly high number of outpatient 

CAP cases. This may be mainly due to different 

coding practice. Nevertheless, CAP poses a 

significant burden in all four countries among 

adults ≥50 years of age. 

25

PL 5.2. 

The role of health authorities in promotion of rational use of antibiotics 

Merjem Hadjihamza 

Drug Bureau - Ministry of Health, Skopje, Macedonia 

Health care systems and health policies differ 

from country to country and they reflect the economic, 

social and even political situation of each 

country. The main goal of any Health authority 

should be creating and implementing of policies 

which will promote the public health, provide 

quality health services at all levels of health care 

and ensure the access of drugs with proven quality 

and safety for the whole population. 

Rational use of antibiotics is of high relevance in 

improving health care and it has emerged as a 

global challenge imposed due to adverse findings 

about their use. 

WHO estimates that more than half of all medicines 

are prescribed, dispensed or sold inappropriately, 

and that half of all patients fail to take 

them correctly. This incorrect use may take the 

form of overuse, underuse and misuse of prescription 

or non-prescription medicines. 

What should be done to prevent irrational use of 

antibiotics? 


First it must be determined exactly what in practice 

means irrational use of antibiotics, what are 

the reasons and consequences of irrational use, 

who are the involved parties and finally, which 

mechanisms must be established in order to promote 

rational use of antibiotics. Having in mind 

the scientific, social and regulatory dimension of 

this phenomenon, Ministry of Health of Republic 

of Macedonia have undertaken many activities 

i.e. published EBM guidelines, Continual medical 

education for health professionals is ongoing process 

since year 2000, last year it has been endorsed 

National strategy for control of antimicrobial resistance 

for 2012-2016. Organizing trainings on 

rational use of antibiotics with population based 

groups is foreseen in future. It may be conluded 

that raising the awareness of all stakeholders regarding 

rationale use of antibiotics is very important, 

it will for sure fight antimicrobial resistance 

and improve public health, decrease antibiotics 

expenditure and save health budget.

Pharmacoeconomic analysis comparing the use of ciprofloxacin and 

metronidazole versus ertapenem in prophylaxis of mayor surgical 

procedures at the University Hospital Rebro 

Ivana Čegec, Robert Likic, Ksenija Makar Ausperger, Viktorija Erdeljic, Matea 

Radacic Aumiler, Danica Juricic Nahal, Luka Bielen, Iva Kraljickovic, Igor Francetic 

University Hospital Center Zagreb, Zagreb, Croatia 

Goal: At the University Hospital Rebro (Zagreb; 

Croatia), combination of ciprofloxacin 2x400mg 

I.V. and metronidazole 3x500mg I.V. is a usual 

antimicrobial prophylaxis for mayor surgical 

procedures. Our aim was to compare daily cost 

of that practice versus ertapenem 1x1gr I.V. 

Materials and Methods: We collected pricing 

data concerning the usual daily doses of ciprofloxacin 

plus metronidazole combination and ertapenem, 

infusion system as well as nursing time 

for one day of therapy and compared them. 

Results: One day of therapy with ciprofloxacin 

and metronidazole combination costs 429.29kn 


PL 5.3. 

(57.2 €) while one day of therapy with ertapenem 

is priced at 374.334kn (49.9€). 

Conclusion: Therapy with ertapenem is significantly 

cheaper (13% less on a daily basis) in 

comparison to ciprofloxacin and metronidazole 

combination. Considering the ertapenem’s broad 

spectrum of antibacterial activity, pharmacokinetic 

and pharmacodynamic characteristics as 

well as its lower cost of treatment, this therapeutic 

option should be given priority in antimicrobial 

prophylaxis for mayor surgical procedures at 

the University Hospital Rebro. 

27

PL 5.4. 

Impact of Ceftriaxone De-restriction on the Cost of Antibiotic Treatment 

Srecko Marusic 1 , Vesna Bacic-Vrca 2 , Jasenka Skrlin 3 , Lado Uglesic 4 

1 Department of Clinical Pharmacology, University 

Hospital Dubrava, Zagreb, Croatia 

2 Department of Clinical Pharmacy, University 

Hospital Dubrava, Zagreb, Croatia 

3 Department of Clinical Microbiology and Hospital 

Infections, University Hospital Dubrava, Zagreb, 

Croatia 

4 Pfizer Croatia d.o.o., Zagreb, Croatia 

Goal: In 2008, cefuroxime was the only second 

generation cephalosporin available in Croatia 

and responsible for largest share of antibiotics 

cost at the University Hospital Dubrava, Zagreb. 

The market price of ceftriaxone, which was included 

in the list of antibiotics with restricted 

use, was about 40% lower then the market price 

of cefuroxime. As a cost-saving measure ceftriaxone 

was removed from the list of restricted 

antibiotics in May 2008 and started to be used 

as first-line antibiotic. The aim of this study is 

comparison of total antibiotic cost and cephalosporins 

and carbapenems costs before and after 

intervention. 

Materials and methods: Data on antibiotic use 

were obtained monthly from the computerized 

hospital pharmacy database. These data are expressed 

as the costs of antibiotics in Croatian 

kunas per 1000 bed days. The observed period 

was 2 years before intervention and 2 years after 

intervention. 


Results: Total antibiotic cost did not change significantly. 

Cost of cefuroxime and ceftriaxone 

showed expected changes, cefuroxime cost decreased 

and ceftriaxone cost increased. Carbapenems 

cost increased significantly. 

Conclusion: Total antibiotic cost did not decrease 

in post-intervention period due to increase 

in carbapenems cost. Increase in the use 

of third-generation cephalosporins led to increase 

in ESBL-positive pathogens and increased 

use of carbapenems. Beside costs, this can have 

negative epidemiological impact in creating hospital 

situations with pathogens producing ESBLs 

and carbapenemases with very limited possibility 

for efficient therapy. Therefore, a reduction in 

use of third-generation cephalosporins and their 

replacement with different types of antibiotics 

seems necessary.

Impact of the Pharma Economic Act on diffusion of innovation, reduction 

of costs and patients’ equity in the Hungarian prescription drug market 

Rok Hren 

University of Ljubljana, Slovenia 

Sažetak: In this study, we examined the impact 

of Pharma Economic Act (PEA), which was introduced 

in Hungary in 2007. The motivation to 

analyze this particular legislative measure within 

a single mid-size country is in its comprehensiveness 

and in its unique approach toward marketing 

authorization holders (MAHs). Moreover, 

recent economic crisis is making such a »laboratory 

of cost-containment tools« attractive for authorities 

and payers not only among the Central 

and Eastern European (CEE) countries, but also 

among Western (e.g., EU-15) jurisdictions. Final 

reason for the analysis is availability of detailed 

data on Hungarian prescription drug market, 

which are provided to the public by the authorities. 

Controlling prescription drugs spending is 

fraught with difficulties, and particularly notable 

are examples of GP Fundholding scheme in the 

UK and prescribing drug budgets in Germany. 

Difficulties arise due to multifactorial reasons 

for pharmaceutical expenditure growth, which 

are usually addressed only partially with national 


PL 6.1. 

prescription drug policies. Typically, the authorities/payers 

introduce two groups of policies: one 

group on the so-called demand side (e.g., physicians, 

pharmacists, and patients), and one group 

on the supply-side (e.g., MAHs). International 

reference pricing has been widely embraced by 

authorities/payers as a particular supply-side 

tool geared toward regulating prices of primarily 

branded drugs. 

Hungarian authorities / payers with PEA took different 

approach and included, among a plethora 

of other measures, strong mechanisms to control 

volume on the supply side, with MAHs being responsible 

to cover any overshoot of the pre-agreed 

volume. In that sense, PEA is unique among CEE 

jurisdictions, however, at its conception there were 

serious warnings that the austerity act may jeopardize 

innovation and could even lead to withdrawals 

of breakthrough branded drugs. Accordingly, we 

are here specifically evaluating the effect of PEA 

on both dynamic and static efficiencies and also 

on equity, which has been historically a controversial 

issue in Hungary. 

29

PL 6.2. 

Ethics as a rising issue for targeted therapies: the metastatic colorectal 

example 

Livio Garattini, Katelijne van de Vooren 

CESAV, Center for Health Economics, ‘Mario Negri’ 

Institute for Pharmacological Research, Italy 

Goal: The number of new biological agents (BAs) 

registered with an indication related to cancer 

treatment is flourishing and the cost of these 

treatments is rising dramatically, making the 

situation potentially unsustainable for healthcare 

services. As an interesting example to draw lessons, 

we focus here on bevacizumab (BV) and 

cetuximab (CX), the first two BAs approved for 

metastatic colorectal cancer (mCRC). 

Materials and methods: We reviewed full economic 

evaluations (FEEs) on BV or CX to analyze 

their results, the literature search was done 

on the PubMed international database to select 

FEEs on BV and CX published in English since 

January 2004. Finally, we selected eight articles. 

Results: Despite frequently arguable estimates 

based on indirect efficacy, only one of the eight 

FEEs reviewed estimated the addition of CX was 

cost-effective in a virtual subgroup of patients, 

albeit with flawed methods. 

Conclusion: Most Western European countries 

reimburse BV and CX for mCRC, though 


both clinical and economic evidence seems very 

weak. The underlying question, hardly made explicit, 

is whether national health authorities are 

prepared to spend an increasing share of healthcare 

budgets on very expensive end-of-life treatments, 

their impact on life expectancy (a few 

additional months at best) and QoL (enhanced 

mainly by patients’ hopes) being doubtful and 

their cost-effectiveness hardly ever proved. Assessing 

these treatments highlights the problems 

raised by market failure in health care, where a 

“third party payer” funds treatments prescribed 

by a physician for a patient who can hardly be 

expected to behave as a rational consumer. 

At present, the fullest approach to decisions on 

reimbursement of new technologies with sustainable 

costs is expected to be the multidisciplinary 

“health technology assessment” (HTA). 

Unfortunately, although ethics is an acknowledged 

part of HTA, there is scant evidence that 

ethical issues are commonly addressed.

Implementation of biological therapy and surgery in the treatment of 

metastatic colorectal cancer: Are the costs justified? 

Renata Dobrila-Dintinjana, Dinko Vitezić 

University of Rijeka Medical School and Department 

of Oncology and Radiotherapy, University Hospital 

Centre Rijeka, Rijeka, Croatia 

Colorectal cancer (CRC) is a disease of high incidence 

and mortality (700 000 deaths annually 

in the world), and it is the third cause of cancer 

deaths in the Western world. Despite prevention 

programs on global and national level at the time 

of diagnosis about 25% of patients have metastatic 

disease, and approximately 50% of patients 

will develop metastatic disease. Although the 

tendency to perceive the occurrence of CRC in 

younger age groups this cancer is still a disease 

of old age group patients (70-75 years). Modern 

methods of treatment with chemotherapy and 

biological therapy significantly prolonged survival, 

but such treatment in developed countries is increasingly 

becoming an important financial issue 

for healthcare systems. The current challenge for 

oncologists and the healthcare systems is how to integrate 

a new set of biological therapy into clinical 

practice and for this purpose it is necessary to apply 

health technology assessment (HTA). 

The fact is that the patients undergoing radical 

surgery have a chance for prolonged survival 

and, according to some authors, for complete 

cure. In the first postoperative year recurrences 

of the disease in 60% or more of patients may 


PL 6.3. 

be expected. Operating costs of treatment are 

high and in combination with systemic therapy 

is a marked impact on health systems around the 

world. 

It is therefore clear why screening programs are 

carried out in spite of unclear evidence about the 

usefulness thereof. The ultimate goal of screening 

is to reduce morbidity and mortality, and the 

diagnosis of the disease at an early stage, as a rule 

does not justify the screening process. The possibility 

that the disease could be detected in earlier 

stages and diminished mortality is a sufficient 

ground to pursue global and national screening 

programs, although there are not enough scientific 

facts which indicate a clear benefit for the 

general population. 

OTA and POHEM screening models showed 

that the 10-year mortality can be reduced by 

17.9% per year and the cost for the life-saved 

year is from US$ 12,000 to 13,500. The most effective 

is the screening of individuals aged 50-74 

years. However, it has not been proved that these 

results can be reproduced in the general population. 

The colorectal cancer screening costs are 

higher than for cervical and breast cancer. 

31

PL 6.4. 

The role of cytology in detection of small breast cancer – experience of 

University Hospital for Tumours, Zagreb (cost benefit?) 

Vesna Ramljak, Iva Bobuš-Kelčec, Merdita Agai, Ljiljana Mayer 

Clinical Hospital Center “Sestre milosrdnice”, 

University Clinic for Tumors, Zagreb, Croatia 

Aim: University Hospital for Tumours is highly 

specialised oncological centre. The majority of 

breast cancer patients in Croatia are surgically 

treated here; more than 3500 woman were operated 

in last 5 years. The aim was to evaluate the 

role of cytology in detection tumours less than 

1cm in size. Long time follow-up indicates much 

better prognosis for such patients than those 

with tumours larger than 1cm. 

Materials and methods: We analysed group of 

patients cytologicaly diagnosed as breast cancer 

and treated in our institution during 2011. 

US guided FNAB was performed and cytological 

diagnosis implied cancer in all cases. Final 

histological report included tumour size and 

differentiation grade, involvement of axillary 

lymph nodes, estrogen and progesteron receptors, 

HER-2 and Ki-67. Separate analysis was 

performed for T1a and T1b group of patients. 

Results and conclusion: There was no difference 

between groups in patients age, 59,2 vs. 59 years 

. As expected differentiation grade was low in 

both groups in more than 90% of patients. In 


majority of patients axillary lymph nodes were 

not involved, (93% and 84%). High expression 

of HER-2 (3+) was found in 3,3% of patients 

in T1a group, and in 7,1 % of patients in T1b 

group. HER-2 was negative in 70% of T1a cases 

and 80% of T1b cases. Mean (range) of Ki-67 expression 

was 19% (3-54) for T1a group, and 12% 

(1-14) for T1b group. Early cytological recognition 

of cancer provided a group of patients with 

excellent prognostic factors. Adjuvant therapy 

is planned based on prognostic factors. In this 

group of patients’ majority received adjuvant 

hormonal therapy – estrogen receptor antagonists 

(tamoxifen) or aromatase inhibitors. In 

only small proportion of patients adjuvant chemotherapy 

was indicated. Our results show high 

value of cytology in detection of small breast 

cancer. Detection of small cancer enables us to 

reduce treatment to surgery, radiotherapy and 

hormonal adjuvant therapy with expected high 

cure rates, low rates of treatment complications, 

good quality of life after treatment, and declining 

costs.

Comparative analysis of patient access to targeted therapies for metastatic 

renal cell carcinoma (mRCC) in selected CEE countries 

Jasmina Krehić 1 , Novka Agić 2 , Vedrana Raguž 3 

1 Clinical Centre of the University Sarajevo, Bosnia 


2 Institute for Health Insurance and Reinsurance of 

the Federation of Bosnia and Herzegovina, Bosnia 


3 Pfizer Croatia, Zagreb, Croatia 

Goal: Our goal was to analyze differences in 

patient access to targeted therapies for metastatic 

renal cell carcinoma (mRCC) between two 

nonEU countries, Bosnia and Herzegovina and 

Croatia, on one hand, and Slovenia as an EU 

member state, on the other. 

Materials and Methods: We performed a study 

using the officially published data from relevant 

national institutions in order to determine first 

registration lags and reimbursement lags of 

new targeted therapies for mRCC indication in 

Bosnia & Herzegovina and Croatia as opposed 

to Slovenia. Data collection was limited to six 

targeted agents that have come into EU market 

since 2005: sorafenib, bevacizumab, temsirolimus, 

sunitinib, everolimus and pazopanib. 


PL 6.5. 

Results: There are considerable variations and 

inequities between selected three countries in 

patient access to targeted therapies for mRCC. 

As a country with all six targeted agents registered 

and reimbursed, Slovenia is a leader. Croatia 

and Bosnia & Herzegovina lag behind Slovenia 

in registration and reimbursement for these 

selected agents.. 

Conclusion: A patient access to targeted therapy 

for mRCC is of clinical importance, knowing the 

fact that this new therapy prologs lives and improves 

quality of life. Our analysis indicates that 

delay in the registration and reimbursement of 

new drugs in one country prevents the patients 

living with life-threatening disease from receiving 

the most effective and safest treatments available 

in another country. 

33

PL 6.6. 

Pharmacoeconomics in Predictive Medicine 

Josip Čulig, Marcel Leppee, Nikolina Skaron-Jakobović 

Zagreb Institute of Public Health, Zagreb, Croatia 

A genomic-based prediction of common diseases 

is still not very informative, and is with little predictive 

power, despite increasing developments 

in genomic research. Risk assessment based on 

a genetic profile is correct when a genetic predisposition 

is the only risk factor for a disease or 

drug therapy. The impact on the health care budget 

might be significant because of the high cost 

of predictive-genetic testing. Pharmaco-economic 

tools could prove to be useful in assisting 

decision-makers on this subject. The pharmacogenomic 

biomarkers have already demonstrated 

superior impact in improving drug efficacy and 

avoiding drug toxicity. As an example of an 

implementation personalised therapy, we have 

analysed the introduction of new medication in 

a selected group of patients with non-small cell 

lung cancer (NSCLC). It is a biologically aggressive 

type of cancer and the leading cause of cancer 

death in men and women. Many tumours, 

including those of the lungs, show increased 


activity of the epidermal growth factor receptor 

(EGFR). Various clinical trials have shown that 

patients with advanced NSCLC and EGFR mutations 

had significant benefits from gefitinib therapy, 

while patients without these mutations did 

not. A budget impact analysis (BIA) compared 

the cost of gefitinib (190.151 HRK, Croatian national 

currency, per patient) and the cost of standard 

chemotherapy (188.724 HRK). There are 

some advantages to gefitinib therapy: prolonged 

time of progression; a higher degree of survival 

in the first line (51%); received in 10 cycles (10 

months) compared to the reference scenario (6 

cycles); fewer side effects (a difference in cost 

of 311 HRK to 4 072 HRK per patient); no cost 

administration of the drug (per os administration 

of medication); better quality of life (higher 

QALY); and other. It is important to establish the 

real cost of the standard procedure in advanced 

NSLC, including genetic testing.

The economic cost analysis of the implementation of centralized pharmacy 

unit for antineoplastic drugs with respect to the premises, equipment and 

technical staff under the supervision of oncology pharmacist 

Vesna Pavlica 1 , Damir Vrbanec 2 , Velemir Danko Vrdoljak 1 

1 Clinical Hospital Center „Sestre milosrdnice“, 

University Clinic for Tumors, Zagreb, Croatia 

2 Clinical Hospital Center Zagreb, Croatia 

Goal:this paper presents the results of long-term 

cooperation between the onclogy pharmacist, 

oncologists and technical support staff, as well as 

the economic and safety justification of the implementation. 

This refers to patient safety, related 

to the reduction in the frequency of medication 

error and staff safety that manipulates antineoplastic 

drugs and the safety of hospital settings. 

Material and methods: all relevant data was collected 

by means of the standardized ESOP questionnaire 

from various hospitals in Croatia and 

by analysis of different project documents. 

Results: results obtained were statistically processed 

and indicate the need for permanent education 

and cooperation between health workers 

and technical support staff, which is of utmost 


PL 6.7. 

importance. The results are the first sistematically 

collected data related to the manipulation 

of antineoplastic drugs in the republic of Croatia. 

Conclusion: antineoplastic drugs are cytotoxic, 

teratogenic, mutagenic and embryotoxic and 

should be subjected to a special preparation and 

manipulation procedures, especially in view of 

their cost. In most countries in the world, and 

in the EU in particular, their preparation takes 

place under a strict control of oncology pharmacists 

and under precisely determined spatial and 

technical conditions. From the data analysis we 

conclude that a pharmacist needs to specialize in 

this pharmacy field and take an active role in the 

promotion of knowledge, thus becoming a part 

of the health care oncology team. 

35

PL 7.1. 

Musculoskeletal disorder - their impact on work ability and societal costs in 

Poland 

Magdalena Wladysiuk, Ksenia Zhelthoukhova, Stephen Bevan, Mateusz Haldas 

CEESTAHC - Central and Eastern European Society 

of Technology Assessment in Health, Poland 

Fundamental changes need to occur in the way 

policy-makers, medical professionals, employers 

and even individuals themselves approach 

the management of long-term conditions. Fit for 

work project was conducted in Poland in 2011 to 

estimated social burden of MSD (musculoskeletal 

disorders) and their on work ability (direct 

and indirect cost). 

Results: Musculoskeletal conditions incurred 

costs of almost 330 million Euros in sickness absence 

and another 470 million Euros in costs of 

disability in 2009. Up to 874 million Euros were 

spent on the welfare benefits of the work disabled 

with only 38 million Euros put to preventative 

rehabilitation. In 2010 total direct costs of 

the conditions of musculoskeletal system added 

up to 937 million Euros, of which only 223 Euros 

were spent on preventative health care. The 


average age of the recipients of the rehabilitation 

benefits in Poland was 46 years meaning that 

increasingly more individuals of prime working 

age require support for managing their longterm 

conditions. At least 12 per cent of registered 

unemployed people in Poland do not seek work 

due to poor health condition. 

The evidence presented in this report illustrates 

that a large proportion of working age people in 

oland are, or will be, directly affected by musculoskeletal 

conditions (MSDs) in the coming 

years. This an have very significant social and 

economic consequences for these individuals 

and their families, it can impede the productive 

capacity of the total workforce and parts of 

Polish industry, and it can raw heavily on the 

resources of both the health system and the benefits 

regime.

Case study in transplantation and immunosuppressant therapy in 

Macedonia, three year follow up 

Stevce Acevski 1 , Zoran Sterjev 2 , Vladimir Indov 1 

1 Alkaloid AD Skopje, Skopje, Macedonia 

2 Faculty of Pharmacy, Skopje, Macedonia 

The aim is to present situation with organ transplantation 

and immunosuppressant therapy in 

Macedonia. Immunosuppressant therapy is essential 

for patients after transplantation, in order 

to suppress immune response, to prevent rejection 

of grafts or transplants. In Macedonisloan 

healthcare system there are tree active transplantation 

procedures, kidney, liver and bone marrow. 

Kidney transplantation is active for 15 years 

and there are more of 160 live patients. Annually 

10 – 20 kidney`s are transplanted. All transplanted 

patients are started initially with immunosuppressive 

therapy, and take lifelong doses. Bone 

marrow transplantation is active for 11 years and 

total 215 patients are transplanted, annually 20 

– 25. One third of are allogenic (other donor) 

transplantations, which by the protocol get immunosuppressant 

therapies, mostly cyclosporine 

and mycophenolate mofetil, for the first six 

months. Liver transplantation is active in Macedonia 

since 2011, only one child is transplanted. 

According to protocols was initially treated with 

tacrolimus. 


PL 7.2. 

Twelve immunosuppressant products are registered 

in Macedonia of which two cyclosporine, 

two antithymocyte immunoglobulin, four mycophenolate 

mofetil, tacrolimus, daclizumab, basiliximab 

and everolimus, of which six are not marketed 

at all. Five generics are on reimbursement 

list of HIF, but only three of them are marketed. 

In 2009 for immunosuppressant therapy was 

spend 593.000 Euro 1.15% of total budget spend 

for medicines. Spending in 2010 decreased to 

522.000 Euro or 12 % less than previous year, 

0.86% of total budget for medicines. Promoted 

use of new immunosuppressive drugs such as 

tacrolimus and sirolimus were main factor for 

increased spending for immunosuppressant 

therapy in 2011 to 590.000 Euro, or 13% more 

compared to 2010 or 0.99% of total budget for 

medicines. 

Nevertheless continuous price reduction of 

the medicines, positive trend in number of 

transplantation\’s and implementing use of new 

immunosuppressant drugs are main factors in increased 

spending for immunosuppressant therapy. 

37

PL 7.3. 

Rare diseases or disorders, orphan drugs and patients equity rights 

Jasmina Krehić 1 , Senka Mesihović Dinarević 1 

1Clinical Centre University of Sarajevo, Sarajevo, 

Bosnia and Herzegovina 

The term “rare diseases” or “rare disorders” by 

definition is different in different parts of world. 

In Europe it is defined as life-threatening or very 

serious conditions that are rare and affect not 

more than 5 in 10,000 persons, in US those are 

diseases/disorders that affect fewer than 200,000 

people and WHO defines an incidence of 0.65- 

1/1000. \’\’Orphan\’\’ medicinal products are 

intended for diagnosing, preventing or treating 

rare diseases/disorders. Although pharmaceutical 

companies are consistantly developing new 

drugs, people with rare diseases/disorders are 

not in focus of their their interes beause numbers 

of those patients are small as well as potential 

market for orphan drugs. But, Article 25.1 

of the Universal Declaration of Human Rights 

states:“everyone has the right to health and well 

being and especially to medical care and social 

services”. So, the right to health protection is universal, 

and ethial issues rising from this Delaration 

clearly oblige governments to ensure pres- 


ence of orphan drugs in the drug market. Regulatory 

agencies in the European Union and the 

United States have thus established Committee 

on Orphan Medicinal Products and Office of Orphan 

Product Development (OOPD) to facilitate 

the development of orphan drugs. Regardless 

of existance of such departments in European 

Medicines Agency (EMEA) and Food and Drug 

Administration (FDA) orphan drugs still have 

to pass through all preclinical and clinical trials 

to prove their efficacy and safety. At the end an 

expensive drug with very rectricted market is developed. 

For that reason access to orphan drugs 

should be facilitated by the whole community 

– from governments, pharmaceutical industry, 

health funds and patient associations. In Western 

Balkan countries should be developed an shared 

network for rare diseases register, strengthened 

cooperation of patient associatioans, education, 

early diagnosis as well as the influence on research 

and health funds and governments.

STEREOLOGICAL ANALYSIS OF TERMINAL VILLI OF HUMAN 

PLACENTAS ASSOCIATED WITH EPH GESTOSIS 

Dinko Vitezić 

University of Rijeka Medical School and University 

Hospital Centre Rijeka, Rijeka, Croatia 

Hypertension is a major risk factor for stroke, 

myocardial infarction, heart failure, chronic kidney 

disease, peripheral vascular disease, cognitive 

decline and premature death. Treatment of 

hypertension is of utmost importance in prevention 

of morbidity and premature mortality. This 

is the reason why antihypertensive drugs are the 

most frequently prescribed and costly drugs in 

most of the countries (Croatia as well). Clinical 

guidelines for hypertension treatment are important 

for adequate drugs usage and among them 

European guidelines (ESH-ECS), United States 

guidelines (JNC-7) and England and Wales 

guidelines (NICE) are the most influential. Pharmacoeconomic 

issues are included in JNC-7 and 

especially in NICE guidelines, while ESH-ECS 

guidelines are strictly clinical with no pharmacoeconomic 

aspect. The NICE analysis and different 

studies showed that treating hypertension 


PL 7.4. 

is highly cost-effective and the result is improved 

health outcomes. Major drug classes resulted in 

overall cost savings when compared to no treatment 

because of the reduction in cardiovascular 

events, which led to savings that compensate the 

relatively low cost of drugs. Certain savings are 

gained because the absolute difference in costs 

between angiotensin converting enzyme inhibitors, 

angiotensin receptor blockers, calcium 

channel blockers and thiazide-type diuretics is 

now much smaller than it was according to previous 

analyses. Further, usage of low cost generic 

drugs could make the impact on savings more 

significant. 

Adequate usage of antihypertensives, according 

to clinical guidelines, has positive pharmacoeconomic 

impact (besides obviously clinical), but it 

would be necessary to perform analyses locally 

to measure dimensions of this savings. 

39

PL 7.5. 

Trends in the utilization of cardiovascular drugs in Croatia during the 

period 2007-2010 

Viola Macolić-Šarinić, Pero Draganić, Josip Čulig, Marcel Leppée, Marinko Bilušić, 

Saša Žeželić 

ISPOR chapter Croatia, Zagreb, Croatia 

Goal: A comprehensive insight into drug utilization 

as an economic and a public health issue 

can only be acquired in the context of the overall 

state of health of the respective population. 

The goal is to investigate the utilization trends of 

cardiovascular drugs in Croatia during the 2007- 

2010 period, with an emphasis on the most common 

pharmacological/therapeutic subgroups. 

This will be compared with the number of patients 

admitted to hospital because of cardiovascular 

events. 

Materials and methods: The Croatian Agency for 

Medicinal Products and Medical Devices collected 

and analyzed data of drug utilization in 

Croatia. The data was used to calculate the number 

of defined daily doses (DDD) and DDD per 

1000 inhabitants per day (DDD/1000/day), in 

the period 2007-2010, using Anatomical-Therapeutic-Chemical 

methodology (ATC). A Public 

Health Institute is analyzing the data obtained 

from hospital statistics. 


Results: The utilization of all cardiovascular drugs 

increased by 47, 55% (from 248, 88 DDD/1000/ 

day in 2007 to 367, 23 DDD/1000/day in 2010), 

while the total cost increased by 13, 09% (from 

863,601,721 HRK in 2007 to 976,657,904 HRK 

in 2010). The utilization of the lipid modifying 

agents (C10) increased the most (78, 93%), followed 

by agents acting on the renin-angiotensin 

system (57, 51%). The calcium channel blockers 

(28, 46%) were next. The total number of hospital 

admissions for cardiovascular diseases decreased 

from 84,413 in 2007 to 81,575 in 2010. 

Conclusion: The utilization of cardiovascular 

drugs increased significantly during the 2007- 

2010 period. In the same period, the number of 

hospital admissions of patients with main cardiovascular 

events (3, 4%) has decreased. A further 

analysis of this co-founder is needed.

Comparative analysis of cardiovascular drugs utilisation in General 

Hospital and Clinical Center in Croatia and Bosnia and Herzegovina 

Mirza Dilić 1 , Aleksandar Knežević 2 , Sanja Sarić-Kužina 3 , Anesa Eminović 1 

1 Clinical Center University of Sarajevo, Sarajevo, 


2 General Hospital Zadar, Zadar, Croatia 


Goal: Our goal was to analyze and compare the 

cardiovascular (CV) drugs utilisation in General 

Hospital Zadar (GHZ) and Clinical Center University 

of Sarajevo (KCUS). 

Materials and methods: Data were collected 

from hospital pharmacies for the period of 2009- 

2011. The drug utilisation in GHZ was expressed 

in DDD/100 bed-days (BD) and in KCUS was 

expressed in number of tablets/pills. 

Results: In the observed period, the utilisation 

of fibrinolitc drugs (alteplaze, streptokinase) in 

GHZ was negligible which correlates with development 

of interventional cardiology there. 

The low-molecular weight heparins utilisation 

was quite high. Looking at the ATC groups, the 

most used beta blocker was atenolol, lacidipine 

among Ca-channel antagonists, isosorbidemononitrate 

among nitrates, ramipril among 

ACE-inhibitors, losartan among sartans, atorvastatin 

among statins, amiodaron among antiarrythmics, 

methyldigoxin among inotropic drugs 

and furosemide among diuretics. In KCUS the 

most used drugs were: carvedilol among betablockers, 

amlodipine among Ca-channel antago- 


PL 7.6. 

nists, glyceril-trinitrate among nitrates, lisinopril 

among ACE-inhibitors, atorvastatin among 

statins, amiodarone among antiarrhytmics, 

methyldigoxin among inotropic drugs and furosemide 

among diuretics. The utilisation of streptokinase 

is still stable and alteplaze utilisation is 

increasing. The sharp growth of enoxaparine was 

observed as well. 

Conclusion: Because the data from GHZ and 

KCUS were collected using different methodologies, 

their comparison was quite difficult. Nevertheless, 

the data are showing trends in CV drugs 

utilisation in both institutions, which are preconditioned 

by type and number of procedures 

in patient treatment, tradition, economic factors 

as well as the influence of pharmaceutical companies. 

According to the principles of evidence 

based medicine, the utilisation of beta-blockers 

and Ca-channel antagonists in KCUS is optimal 

as well as the utilisation of ACE-inhibitors, sartans 

and nitrates in GHZ. In other ATC groups 

there is no difference among hospitals and most 

used drugs are the optimal ones. Our analysis 

indicates the differences in CV drugs utilisation 

among two hospitals which could be better explained 

by using unique methodology. 

41

PL 8.1. 

DIFFERENTIAL DIAGNOSIS OF CLEAR CELL TUMORS 

Nenad Vanis 1 , Rusmir Mesihović 1 , Aida Saray 1 



Many diseases are associated with loss of appetite 

or inability to ordinary intake food. The 

consequence of long-term or even short –term 

inability to intake food leads to the damage of 

tissue and organ function. Loss of tissue, which 

is accelerated through metabolic effects of inflammatory 

mediators, is a feature that is identified 

as a clinical malnutrition. The aim of this paper 

is to offer a major guide for malnutrition risk 

detection, proposing several standards that are 

practical for general use in patients and healthcare 

workers. 

Methodology and subjects: This systematically 

planned, descriptive, two years (2008 to 2010) 

prospective clinical study included a total of 

2200 patients hospitalized in the Clinical Center 

of the University Sarajevo. Subjects were hospitalized 

patients with clear diagnose who came 

for assessing the nutritional status and prevalence 

of hospital malnutrition. 

Results: According MUST test malnutrition 

was detected in 58%, and the test relies more 


on subjective assessment of the patient and is 

not acceptable for general screening. According 

to NRS 2002 test, malnutrition was detected 

in total of 52.04% patients who were placed in 

other clinics. This test is convenient because the 

answers with formulation as “yes” or “no” are 

acceptable for the patient and final screening is 

simple. According to the MNA test malnutrition 

is detected in total of 55.3% patients but the 

test is not suitable because answers are more subjective 

and not acceptable for the patient as well 

as for physician. 

Conclusion: More than 55% subjects were detected 

as proven clinical malnutrition with all 

three tests. The greatest risk of malnutrition 

among internal medicine diseases have oncologic 

patients. BMI should be routinely done on the 

first examination. NRS 2002 test is suitable and 

acceptable tfor patient. 

Keywords: Prevalence, Hospital malnutrition, 

screening

Modelling the European Burden of Disease Associated Malnutrition 

András Inotai 1 , Mark Nuijten 2 , Eric Roth 3 , Refaat Hegazi 4 , Zoltán Kaló 1,5 

1 Syreon Research Institute, Budapest, Hungary 

2 Ars Accessus Medica; Erasmus University 

Rotterdam, Rotterdam, Netherlands 

3 Department of Surgery, Medical University of 

Vienna, Vienna, Austria 

4 Abbott Nutrition, Columbus, Ohio, USA 

5 Eötvös Loránd University, Budapest, Hungary 

Background: Disease associated malnutrition 

(DAM) is a frequent but often unrecognised 

problem, even in the developed world. DAM is 

associated with increased morbidity, number 

and severity of complications arising from the 

primary disease and, consequently, increased 

utilisation of health care services and decreased 

quality of life (QoL). 

Objective: To estimate the health and economic 

burden of DAM in Europe. 

Design: An Excel spreadsheet model was developed 

to estimate direct incremental health care 

costs and health burden (including increased 

mortality and reduced QoL expressed in lost 

quality adjusted life years [QALYs]). The monetary 

value of health loss was calculated by multiplying 

lost QALYs with explicit or implicit cost 

effectiveness thresholds. Ten primary diseases 

were incorporated into the model: stroke, coronary 

heart disease, breast cancer, colorectal cancer, 

head and neck cancer, chronic obstructive 


PL 8.2. 

pulmonary disease, dementia, depression, musculoskeletal 

disorders and chronic pancreatitis. 

Results: The direct financial burden of DAM is 

over 31 billion EUR annually. DAM is responsible 

for 5.7 million lost life years and 9.1 million 

QALYs. The total monetary value of health 

and financial burden of DAM exceeds 305 billion 

EUR in ten primary diseases. Conclusions: 

In Europe, DAM is a considerable health and financial 

burden and represents a significant contribution 

to the total burden of disease, estimated 

by World Health Organization to be 255 million 

disability adjusted life years (DALYs) annually in 

Europe. The model highlights the necessity and the 

importance of further economically relevant studies 

in the medical nutritional area as potential inputs 

for future economic models. Therefore, policy 

makers should support programmes to extend the 

clinical and economic evidence base of nutritional 

care, with the ultimate aim of reducing the resource 

burden associated with malnutrition. 

43

PL 8.3. 

From Morisky to Hill-Bone: measurement of adherence to medication 

Josip Čulig, Marcel Leppee 

Andrija Stampar Institute of Public Health, Zagreb, 

Croatia 

Goal: Adherence to medication is measured in 

several ways. 

Materials and Methods: Direct methods include 

measuring the concentration of drug or metabolite 

in the body (blood, urine, biological markers) 

and those are the most accurate, but also 

very expensive and complex. Therefore, the most 

commonly used indirect methods are patient 

and clinician report, pill counting system, electronic 

medication monitors, rates of prescription 

refills, patient diaries and patient self-reports or 

questionnaires as the most important ways of 

measuring adherence. Self-report measures have 

the benefits of being cheap, easy to administer, 

non-intrusive, and able to provide information 

on attitudes and beliefs about medication. Potential 

limitations to self-report are that ability 

to understand the items, and willingness to disclose 

information can affect response accuracy 

and thus questionnaire validity. 

Results: The best known and most widely usable 

scale for research adherence is MAQ (Medication 

Adherence Questionnaire) by Morisky, 

which has several advantages: identifies barri- 


ers to nonadherence, is the shortest scale, easiest 

to score and very adaptable for various groups 

of medication. SEAMS (Self-Efficacy for Appropriate 

Medication Use Scale) is a 13-question 

scale, more complex than the previous one. 

BMQ (Brief Medication Questionnaire) consists 

of four main question headings (regimen, belief, 

recall and access screen) and multiple subquestions. 

MARS (Medication Adherence Rating 

Scale) is a 10-question scale focused mainly on 

psychiatric populations. ARMS (Adherence to 

Refills and Medication Scale) is a valid and reliable 

medication adherence 14-question scale 

when used in a chronic disease population, with 

good performance characteristics even among 

low-literacy patients. The Hill-Bone Compliance 

Scale address barriers and self-efficacy and 

focuses on hypertensive patients. Some scale are 

modified depending on the disease or kinds of 

medication. 

Conclusion: No gold-standard medication adherence 

scale exists, but MAQ is most adaptable 

at the point of care and across populations.

The cost of diabetes mellitus in Macedonia 

Donka Pankov, Zoran Sterjev, Ljubica Suturkova 

ISPOR-Skopje, regional ISPOR chapter from 

Republic of Macedonia, Skopje, Macedonia 

Diabetes as a chronic disease is associated with 

economic and social influence on the health system. 

The aim of our study was to estimate the direct 

cost of providing health care to patients with 

Diabetes in R.Macedonia, to asses the economic 

impact of complications on the costs of diabetes 

and costs for treatment of diabetes and other 

unrelated health costs.The costs of diabetes and 

its complication were obtained retrospectively 

as an economic evaluation which derived costs 

from national DRG values and from official price 

lists for outpatient care in Macedonia.Тhere 

are 23 Medical Diagnostic categories (MDC) 

which are used by Macedonian Health Insurance 

Found (FZO). The annual costs caused by 

diabetes patients in Macedonia in 2010, which 

includes inpatient treatment and medication, is 

approcsimately 15 million Euros. The ambulato- 


PL 8.4. 

ry treatment, laboratory and the other costs are 

not included. Diabetes medication (insulin, oral 

antidiabetic drugs) accounted to 8,79 million euros, 

hospital costs amount to 5,5 million euros 

in 2010 and 6,23 million in 2011. The analysis 

of the costs for 2010 and 2011 show that 50% 

of the total costs are allocated for treatment of 

CVC, 12% are allocated for treating direct moderate 

and severe complication of diabetes (ketoacidosies 

and etc), 10% are due to stroke and the 

other complication of the nervous system, 3% of 

the costs are related with kidney complications, 

2% for eye complications, 4% for diabetic foot 

and the rest of the costs are related with the other 

17 MDC. In conclusion, diabetes has a high costs 

to society. Because of the high cost of treating 

diabetes and its complications, preventive measures 

should be implemented. 

45

PL 8.5. 

Cost-Effectiveness of Interventions to Control Diabetes Mellitus and 

Prevent Complications 

Terezija Šarić, Tamara Poljičanin, Željko Metelko 

Promeritus savjetovanje d.o.o., Zagreb, Croatia 

Objective: To estimate the incremental cost-effectiveness 

of intensive glycemic control (relative 

to conventional control), intensified hypertension 

control and reduction in serum cholesterol 

level for patients with type 2 diabetes. 

Methods: In the Markov framework, a series of 

patient cohorts diagnosed as having diabetes 

progressed through the model. The model is 

based on the assumption that the natural history 

of type 2 diabetes and its complications 

and comorbidities can be described by a series 

of discrete health states that represent the microvascular 

and neuropathic complications of 

type 2 diabetes (retinopathy, nephropathy, and 

neuropathy) and the two major comorbidities 

(stroke and coronary heart disease). Cohorts 

were followed-up along the disease paths for 10 

years. Health resource use and associated medical 

costs are analyzed by type of diabetes complication 

and health resource category. 

Results: Based on use of resources driven by trial 

protocol, the incremental cost-effectiveness of 


intensive glycemic control, intensified hypertension 

control and reduction in serum cholesterol 

level was cost saving. Although the standard 

treatment cost increased moderately, the complications 

cost dropped significantly. Over 10 

years, average undiscounted total savings for 

direct medical costs were estimated to be 273,5 

mil EUR. Interventions directly affected cumulative 

incidence of complications by reducing the 

transition probabilities for complications. A very 

large proportion of the reduction in direct medical 

cost was attributable to a decrease in hospitalization 

expenditure. For patients with stroke and 

coronary heart disease hospitalization represents 

the largest proportion of total cost. 

Conclusion: This study has confirmed that better 

disease monitoring and complication prevention 

would save substantial resources. Economic data 

on the costs of diabetes are essential to motivate 

decisions that can reduce the national burden of 

the disease and to optimize resource allocation.

Symptomatic therapy for cold and flu – Macedonian case 2011 

Stevce Acevski 1 , Vladimir Indov 1 , Zoran Sterjev 2 , Rubin Zareski 2 

1 Alkaloid AD Skopje Macedonia 

2 Faculty of Pharmacy, Skopje, Macedonia 

Market of pharmaceutical products for treatment 

of cold and fly in R. Macedonia as globally, 

increases in its volume of sales. In this study 

we evaluated the utilization of combination of 

the products for cold and fly, prepared in form 

of sachets, ready for preparing hot or cold drink, 

with major recommendations 48 – 72 hours 

treatment, taken every 6 – 8 hours. We analyzed 

utilization of following combinations: 500 

mg acitysalicilic acid plus 30 mg pseudoefedrin 

registered and marketed since 2009, 1000 mg 

paracetamol and 12.2 mg phenylephrine hydrochloride 

registered and marketed since 2010, and 

500 mg paracetamol, 25 mg feniramine maleat 

and 200 mg ascorbic acid with additional forms 

with same active ingredients but without sugar 

registered and marketed for more than 10 years. 

The sale of the three top brand products in 2011 

showed that 4.042.780 doses of combined prod- 


P 01 

ucts for symptomatic therapy products were sold 

or by the recommendation almost 500.000 times 

Macedonian patients treated itself with combine 

therapy for relieve of symptom’s of cold and fly. 

This is almost 25% of all population. Market 

share of the evaluated three products were as follows: 

500 mg acitysalicilic acid plus 30 mg pseudoefedrin 

0.71%, 1000 mg paracetamol and 12.2 

mg phenylephrine hydrochloride 33.39% and 

500 mg paracetamol, 25 mg feniramine maleat 

and 200 mg ascorbic acid with 65.90 %. 

We could conclude that 500 mg paracetamol, 

25 mg feniramine maleat and 200 mg ascorbic 

acid dominated on the market of pharmaceutical 

products for symptomatic treatment of cold 

and fly, but 1000 mg paracetamol and 12.2 mg 

phenylephrine hydrochloride rapidly increases 

its sales and builds up its market share, and treats 

dominating position. 

47

P 02 

Economic evaluation of decreasing persistant hypertension with renal 

denervation device cutting costs of hypertension commorbidities in 

upcoming Croatian practice 

Vanesa Benković 1 , Ranko Stevanović 1 , Ana Ivičević 1 , Marko Matulović 2 , 

Bojan Jelaković 3 

1 Croatian Society for Pharmacoeconomics and 

Health Economics Zagreb, Croatia 

2 Medtronic Zagreb, Croatia 

3 Department for nephrology and arterial 

hypertension, Clinical Hospital Centre Zagreb, 

Croatia 

Goal: to assess cost saving of decrease in persistant 

hypertension using renal denervation, a 

novel a catheter-based procedure 

Materials and Methods: using RCT data on decreasing 

commorbidities of hypertension and 

Framingham risk score a model is set to establish 

and structure cost in cardiovascular, cerebrovascular 

and renal commorbidities. Cost savings in 

commorbidities is assessed in Croatian setting 

using current prices and DRG tariffs. Epideimology 

data is taken from existing research such as 

registries and Croatian Health Survey. 

Results and Conclusion: Hypertension is a 

major risk factor for stroke, ischemic heart disease, 

heart failure, end stage renal disease and 

peripheral arterial disease. Renal denervation 

with the Symplicity Catheter System is a new 

catheter-based procedure for treatment-resistant 


hypertension. Treatment-resistant hypertensive 

patients currently have no additional treatment 

options; they represent a significant unmet clinical 

need. Using one time renal denervation may 

significantly decrease systolic blood presure 

(SBP) - up to 32 mmHG SBP in six months, with 

sustainable effect. Decreasing the SBP is associated 

with decrease in incidence of ischaemic 

heart disease, renal failure, cerebrovascular insult 

and correlated mortality. As they all negatively 

impact quality of life they also increase the 

economic burden of the disease. The novel renal 

denervation procedure brings excellent options 

for unmet need in persistant hypertension and 

decreases cost in hospitalizations, drugs and rehabilitation 

from the budget holder and the hospital 

perspective.

Codiffication as a method in research on animal models in 

pharmacoeconomical efficiency 

Iris Broman 

School of Medicine Osijek, Osijek, Croatia 

Contemporary research on animal models embraces 

a wide pallet of models, research approaches 

and subjects of interests. In order to 

improve the insight of the results of these activities 

and reduce repetitions or mistakes during 

the process, rationalize the need of the animal 

use, we recommend codification as a method in 

the practical approach. Codification can be reduced, 

by certain definition, to the formal method 

in legislative techniques, that can be separated 

from legal authorities. On the other side, there is 

no use in gathering data and regulations unless 


P 03 

they are placed in the practical order and if they 

are not fulfilling each other with means of purpose. 

(If the codification gets applied unsightly, 

it makes the base of a quality management). Research 

on animal models is conducted globally. 

Besides the rigid definition of science, it enters 

the field of the global economy, international 

legislation, environment protection and others. 

Codification, as a method, helps the variety of 

groups of interests, more organized, easier and 

practical link. 

49

P 04 

The role of pharmacoeconomics in medicines reimbursement decisionmaking 

in Bosnia and Herzegovina 

Tarik Čatić, Igor Martinović, Begler Begović 

Society for Pharmacoeconomics and Outcomes 

Research in Bosnia and Herzegovina - ISPOR BH 

Regional Chapter, Sarajevo, Bosnia and Herzegovina 

Goal: Pharmacoeconomics is relatively new concept 

for Bosnia and Herzegovina health care decision 

makers. Education in this field is not sufficient, 

and it ismain reason for lack of experts in 

this field. Decision on reimbursement of medicines 

and other technologies are made on different 

levels due to decentralised health system 

and by different stakeholders (Entities/Cantonal 

Health Insurance Funds-HIF, Hospitals, Ministries 

of Health-MoH). Objective of this survey 

was skreening of current situation and understanding 

of pharmacoeocnomics principles, 

process and implementation in decision making 

proces among key stakeholders. 

Materials and Methods: A nine-question survey 

has been distibuted to 50 stakeholders involved 

in reimbursement decisions. Survey include 

questions on current process of reimbursement 

decisions, existance of pharmacoeconomic criteria, 

and reasons for de-listing of reimbursed 

medicines with two months deadline. 

Results and Conclusions: Overall response rate 

was 30%; 50% (6/12) of MoH, 42% (5/12) HIFs 


and 17% (4/24) Hospitals respond. 73% respondents 

use criteria for decisions on drug reimbursement. 

Mostly used criteria are expert opinions 

(47%) and pharmacoeconomic studies provided 

by the manufacturer (40%), 33% base decision 

on price. Most of respondents use mixed 

criteria. Official bodies in form of commission 

are established in 7 institutinons, mostly in MoH 

and HIFs. This bodies consist of physitians and 

pharmacists, and only 2 of respondents include 

economicst into these bodies. Similar situation 

is observed in case od medical devices and 

other technologies reimbursement decisions. 

De-listing is recorded in 40% respondents but 

main reason was production discontinuation. 

Although the response rate is low, it allows conclusions 

that correlate with the experience and 

current practices. There is a need for a systematic 

approach to HTA and adoption of clearer criteria 

for reimbursement decision-making. Establishing 

HTA bodies consisted of trained professionals 

would improve the reimbursement decisions 

and make it more transparent.

Evaluation of utilization of old versus newer antiepileptic drugs in Republic 

of Macedonia 

Bojana Danilovska, Zoran Sterjev, Ljubica Suturkova 

ISPOR –Skopje, regional ISPOR chapter from 

Republic of Macedonia, Skopje, Macedonia 

Goal: New, ‘second generation’ antiepileptic 

drugs (AEDs) which have entered the marketplace 

since 1990 are currently taken by approximately 

16% of patients with epilepsy worldwide. 

Concerning the efficacy of these drugs in comparison 

to the older ones, they are generally 

considered to have equal efficacy. In some conditions 

are slightly more efficacious but the differences 

in price are still very big. In the present 

study we evaluated and compared utilization and 

cost of “old” and “newer AEDs” which are present 

in reimbursement drug list in R.Macedonia, 

for the period 2009-2010. 

Materials and methods: We used official data obtained 

from Health Insurance Found of Republic 

of Macedonia (FZO) and defined daily dose 


P 05 

(DDD), as a method for drug use evaluation, 

defined by WHO Collaborating Centre for Drug 

Statistics Methodology. 

Results: Carbamazpine (CBZ) was commonly 

prescribed antiepileptic drug in comparison with 

other AEDs (0,00053DDD/1000 people per day 

in 2009 and 0,00074 DDD/1000 people per day 

in 2010). The FZO cost for AEDs 2009 v.s. 2010 

was: 268915 v.s. 278257 euros for CBZ, 314821 

v.s. 365101euros for Valproic acid (VAL), 116433 

v.s. 100361 euros for Lamotrigine and 313522 v.s. 

184875 euros for Topiramate. 

Conclusion: The trend of utilization of the standard 

AEDs in Macedonia showed that the old 

AEDs are stiil therapy of choice for treatment of 

epilepsy. 

51

P 06 

DEMENTIA- can forgetfulness be significant social issue? 

Vedran Đukić 1 , Nenad Bogdanović 2 


2 Pfizer Primary Care Business Unit Europe, London, 

UK; Karolinska Institutet, Stockholm Sweden 

Goal: Our goal was to evaluate costs that are 

generated for diagnosis, treatment and care of 

dementia patients and are resources adequately 

allocated in Croatia and Bosnia Herzegovina 

comparing to the European Union countries. 

Materials and Methods: Data were collected 

from several available pharmacoeconomical 

analysis and epidemiological studies. 

Results: Diagnosis, treatment and care of dementia 

patients represent significant cost for 

every society, especially in highly developed and 

emerging countries. 


Conclusion: Amount of money spent in EU 

countries is around 22.000€ per year and per 

patient, while in Croatia it is around 13.000€. In 

Bosnia and Herzegovina difference is even bigger. 

Based on current predictions, number of 

patients with dementias, including Alzheimer’s 

disease, will be tripled until 2050. Current disease 

awareness, early diagnosis, treatment and 

care options are not fully explored so there are 

still unmet needs for those patients which can 

improve quality of life and reduce costs.

Comparison of cost effectivenes of total hip and knee endoprotesis with and 

without prolonged thromboembolic prophylaxis 

Ismet Gavrankapetanović 1 , Faris Gavrankapetanović 1 , Mehmed Jamakosmanović 1 , 

Slobodanka Bolanča 2 




Total hip (THR) and knee replacement (TKR) 

surgeries are known to be highly successful and 

cost effective treatments for degenerative joint 

diseases in large number of elderly patients who 

are at increased risk of deep venous thrombosis 

and venous thromboembolism (VTE), including 

pulmonary embolism (PE). VTE is one of the 

most common complications among patients 

undergoing orthopaedic surgery, and a leading 

cause of preventable mortality after elective orthopaedic 

surgery. In the absence of prophylaxis, 

it has been estimated that 40-60% of patients 

will develop venographically-detected deep vein 

thrombosis (DVT), seven to 14 days after major 

orthopaedic surgery. The overall mortality 

risk after hip arthroplasty has been reported as 

0.7% with a baseline risk of DVT in the absence 

of prophylaxis of 44% and an incidence of pul- 


P 07 

monary embolism of 3%. Although the overall 

mortality is not as significant as that reported for 

THR with the incidence of fatal and non-fatal PE 

probably less than 1%, the baseline risk for DVT 

including asymptomatic DVT may be as high as 

60%. 

In this study in addition to clinical efficacy we 

also considered complications of VTE and its 

prophylaxis (e.g. bleeding, PE). 

Our findings and recommendations are consistent 

with those observed in scientific literature 

relevant health technology reports and have 

been included in our hospitals treatment guidelines: 

combination of mechanical and prolonged 

pharmacological treatment of patients at high 

risk for DVT and PE together with early mobilisation 

and discharge has been assessed to be the 

most cost efficient in terms of QALYs gained. 

53

P 08 

Human papillomavirus vaccination of boys: cost-effectiveness analysis 

Rok Hren 

University of Ljubljana, Ljubljana, Slovenia 

The objective of the study was to analyze costeffectiveness 

of a human papillomavirus (HPV) 

vaccination of boys at age 12 against oropharyngeal 

carcinoma and anogenital warts. Due to 

availability of the data, we applied the Markov 

model to the conditions of potential national 

immunisation program in the United Kingdom. 

Comparison of HPV vaccination of boys at age 

12 vs. no vaccination resulted in ICER exceeding 

100,000 GBP per QALY. The outcome was sensitive 

to the vaccination costs, the probability of 

developing oropharyngeal carcinoma and anogenital 

warts, and proportion of oropharyngeal 

carcinoma attributable to infection with types 


HPV-16 and HPV-18. When comparing quadrivalent 

and bivalent vaccines, resulting ICER 

was 5,205 GPB per QALY. Our results indicate 

that HPV vaccination of boys with quadrivalent 

vaccine is at present deemed not cost-effective, 

i.e., ICER exceeds willingness-to-pay threshold 

of 30,000 GBP per QALY. Comparison of quadrivalent 

and bivalent vaccines revealed that the 

additional benefits of protection against anogenital 

warts would favour quadrivalent vaccine as 

the vaccination choice. An increase in incidence 

of HPV-positive oropharyngeal carcinoma and 

anogenital warts, and reduction of vaccination 

costs could substantially reduce ICER.

Cost-effectiveness of combined treatment of metformin and fenofibrate on 

retinopathy progression 

Rok Hren 1 , Radomir Cerovic 2 

1 University of Ljubljana, Ljubljana, Slovenia 

2 National Insurance Fund, Belgrade, Serbia 

Goal: To evaluate the cost-effectiveness of intensive 

glycemic control (metformin) combined 

with fenofibrate in its impact on retinopathy 

progression compared to the treatment with 

metformin only in patients with type 2 diabetes. 

Design: Markov decision model of retinopathy 

progression. 

Population: 40-year old patient with type 2 diabetes 

followed for 29 years. 

Main outcome measures: Risk of visual impairment; 

incremental cost-effeciveness ratio (ICER) 

for the two treatment options: one combining 

metformin and fenofibrate, and one using solely 

metformin. 

Results: Combined tretament of metformin and 

fenofibrate resulted in ICER of -133.06 GBP 

per QALY which means that the intervention is 

not only effective but is also potentially saving 

money to the National Health Service; tretament 

solely with metformin is therefore dominated. 

Conclusions: Results of our study suggest that 

patients suffering from type 2 diabetes will re- 


P 09 

ceive from additional treatment with fenofibrate 

substantial benefits of protection against 

early microvascular complications related to 

retinopathy, including blindness. The favorable 

cost-effectiveness of intensive glycemic control 

combined with fenofibrate will likely be further 

increased if other major microvascular complications 

(e.g., non-traumatic amputations) and 

macrovascular complications (e.g., total cardiovascular 

events) of type 2 diabetes are taken into 

account. 

What this study adds? Our study is one of the 

first to compare cost-effectiveness of combined 

treatment of metformin and fenofibrate with 

current intensive glycemic control using solely 

metformin in its impact on retinopathy progression. 

Our study also provides evidence which 

may be useful in shaping the current clinical 

practice in the United Kingdom and European 

Union. 

55

P 10 

Evaluation of cost-saving of Clopidogrel pharmacogenetic testing in patient 

with atherotrombotic disorders from R. Macedonia 

Aleksandra Kapedanovska Nestorovska, Zorica Naumovska, Zoran Sterjev, 

Aleksandar Dimovski, Ljubica Suturkova 

Faculty of Pharmacy, Skopje, Macedonia 

The CYP2C19*2 variant is related with reduced 

clopidogrel therapy responsiveness in patients 

with atherotrombotic disorders (ATD), increased 

adverse cardiovascular event (ACE) 

rates, poorer cardiovascular outcomes and attenuated 

therapy benefits. The aim of this study 

is evaluation of the cost of CYP2C19*2 genetic 

testing for reducing the incidence of clopidrogel 

ACE rates in ATD patients from R. Macedonia. A 

total of 67 patients with ATD, treated with standard 

clopidogrel induction/maintenance therapy 

(600 mg/75 mg) were included in this study. 

All patients were randomized in to two patient’s 

subgroups: responders, N= 38 (57%) , who did 

not developed any ACE and non - responders 

group, N=29 (43%), who developed ACE during 

the follow up period. National hospital DRG 

discharge codes were used to determinate the 

costs of hospitalization for ACE during exposure 


to clopidogrel therapy or after. The cost of PGx 

testing was calculated according to the standard 

protocols for CYP2C19*2 pharmacogenetic testing 

in the Center for biomolecular pharmaceutical 

analyses (CBMA) at the Faculty of Pharmacy 

in Skopje and is 50 euros/per patient. The cost 

of clopidogrel therapy per patient in R. Macedonia 

is approximately 390 EUR per year. The cost 

of ACEs related to therapy failure range from 

226 to 5910 EUR per patient depending on the 

type of ACE. Clopidogrel therapy cost for nonresponder 

patient group in our study was 3510 

EUR. Additionally, estimation of 6554 EUR is 

the minimal cost of hospital treatment for nonresponder 

patients. Using PGx testing will allow 

us to predict the treatment phenotype of patients 

and the cost of those analyses in our group of 67 

patients is estimated to be 3350 EUR. The use of 

this genetic testing is economically justified.

Influence of increased linezolid utilisation on development of antimicrobial 

resistance to linezolid 

Aleksandar Knežević 1 , Sanja Sarić-Kužina 2 , Ivanka Matas 3 

1 General Hospital Zadar, Zadar, Croatia 

2 Pfizer Croatia d.o.o., Zagreb, Croatia 

3 Institute of Public Health, Zadar, Croatia 

Goal: Our goal was to evaluate the influence of 

increased linezolid utilisation on the development 

of resistance to the drug in General Hospital 

Zadar. 

Materials and Methods: Data were collected from 

hospital pharmacy and microbiology laboratory 

for the period of 2005-2011. The utilisation of linezolid 

in GHZ was expressed in DDD/100 beddays 

(BD). The susceptibility of MRSA, MSSA, 

Pneumococcus and Enterococcus isolates to linezolid 

was tested regularly. 

Results: In the period from 2005-2011, the utilisation 

of linezolid increased from 0.002 to 0.353 


P 11 

in DDD/100 BD, i.e. 176 times, but at the same 

time resistance to linezolid was not observed. 

Conclusion: Although resistance to linezolid had 

been rarely reported in literature, our evaluation 

confirms that in spite of huge increase in utilisation 

of linezolid, this drug remains the reliable 

therapy of infections caused by susceptible bacteria. 

The fact that linezolid was all the time on 

the list of “reserve antibiotics” probably contributes 

to this. It shows also that the use of relatively 

expensive drug can be cost-effective because it 

enables effective therapy without or very small 

possibility of failure. 

57

P 12 

Institutional and normative framework of drug control costs in the 

Republic of Macedonia 

Kostadinka Kozareva, Ana Petrovska Angelovska 

Bayer doo Ljubljana, Representative office Skopje, 

Skopje, Macedonia 

One of the main goals of every healthcare system 

is to provide quality, timely and accessible 

healthcare services for the population. The analyzis 

show that health and pharmaceutical costs 

in the last 30 years grow significantly more than 

GDP growth. And therefore there is a need for 

effective control of health care and pharmaceutical 

costs by payers for healthcare and pharmaceutical 

services. 

Goal: The goal of the paper is to make analysis 

of institutional and normative framework as an 

important prerequisite for the implementation 

of the specific model of control mechanisms of 

drug costss. 

Material and methods: This study used several 

methods: the historical method, used to analyze 

the historical development of pharmacoeconomic 

theory and practice in the Republic of 

Macedonia; normative method is applied in research 

and analysis of the legal framework upon 


which to realize the essence of individual control 

mechanisms of drug costs, content analysis 

is used as a method of research which wants to 

build a systematic record of experienced communication 

as one aspect of social life. 

Results: The analysis shows that in recent years 

Republic of Macedonia has introduced a number 

of normative solutions by which there have been 

implemented numerous control mechanisms of 

drug costs. 

Conclusion: From the analysis of the established 

control mechanisms for drug costs in the RM, 

we can conclude that Macedonia in the past few 

years has achieved considerable success with the 

implementation of a series of control mechanisms, 

which led to a significant reduction in 

drug costs, but there is still open room for further 

improvement of the existing model in order 

to increase the quality of care and to protect citizens 

from the additional financial costs.

Antidiabetic drug expenditure in Bosnia and Herzegovina - 2009/2010 

Jasmina Krehic 1 , Zelija Velija Asimi 2 

1 Department for Clinical Pharmacology, Clinical 

Centre of the University Sarajevo, Sarajevo, Bosnia 


2 Clinic for Endocrinology and Diabetes, Clinical 

Centre of the University Sarajevo, Sarajevo, Bosnia 


Objective: To compare drug expenditure for diabetes 

in Bosnia and Herzegovina (B&H) comparing 

years 2009 and 2010. 

Methods: Research was based on data published 

in latest official annual reports from national 

Drug Agency of B&H and official reports from 

The World Bank. Analysis was performed for all 

available drugs from ATC A10 group. ATC A10 

groups from 2nd to 5th level were identified, calculated 

and compared between two years – 2009 

and 2010. 

Results: In 2009, total drug expenditure in 

B&H was 238.852.446,5 EUR compared to 

269.015.061,8 EUR in 2010 (increase of 11,2%). 

A10 group was at high, fifth place in total drug 

expenditure with 12.512.110,6 EUR (5,24%) 

share in 2009 and in 2010 A10 group moved 

up at third place in (total) with 19.900.252,8 

EUR share (7,4%). Portion of A10A group at 


P 13 

3rd ATC level of total antidiabetic drug expenditure 

was 7.531.246,9 EUR (60,2%) and A10B 

was 4.980.863,7 EUR (39,8%) in 2009 (ratio 

A10A:A10B = 1,5) while in 2010 that ratio was 

14.291.116,5 EUR (71,8%) for A10A group and 

5.609.136,3 EUR (28,2%) for A10B group, 2,5 

respectively. In the same time GDP in B&H decreased 

from 17 billion US$ in 2009 to 16,5 billion 

US$. 

Conclusion: Our results show that total drug expenditure 

in B&H significantly increased in 2010 

year with regard to 2009 as well as total drug 

expenditure for diabetes. Some changes can be 

explained with withdrawal of some A10A and 

A10B group drugs from market, but such alarming 

increase of antidiabetic drug expenditure requires 

attention of all health authorities regarding 

development of national diabetes guidelines. 

59

P 14 

Cost effectiveness of renal sympathetic denervation in patients with 

refractory hypertension: decision modelling of applicability for Croatian 

health care 

Robert Likić, Ksenija Makar Aušperger, Viktorija Erdeljić, Matea Radačić Aumiler, 

Igor Francetić, Bojan Jelaković 

University Hospital Center Zagreb, Zagreb, Croatia 

Goal: Renal sympathetic hyperactivity contributes 

to the severity of hypertension and significantly 

determines treatment resistance, accelerating 

clinical course and increasing risk of 

stroke,, heart failure, myocardial infarction and 

chronic kidney disease. Catheter based renal 

sympathetic denervation (RSD) has recently 

been shown to effectively reduce blood pressure 

in up to 84% patients with refractory hypertension. 

We assessed decision modelling scenarios 

for cost effective application of this novel therapeutic 

method in Croatian health care. 

Materials and methods: Data regarding the prevalence 

of complications of hypertension were 

collected from the literature. Costs of hospital 

treatments and pharmacotherapy were obtained 

from the Croatian Institute’s for Health Insurance 

online Cezih and DTS gruper databases as 

well as the Institute’s online drug lists. Pricing for 

the RSD catheter electrodes was provided by the 

supplier. TreeAge Pro 2011 software suite was 

used for decision modelling. 

Results: Two decision three models were constructed. 

The first compared the cost effective- 


ness of standard care with associated complications 

of refractory hypertension with that of the 

RSD. The second model additionally took into 

account the costs associated with rehabilitation 

and diminished quality of life following debilitating 

events caused by refractory hypertension. 

Both scenarios suggest RSD is not immediately 

cost effective, however depending on the model, 

it should be considered in patients with treatment 

resistant hypertension lasting between 2.5 

years (model 2) and/or 7 years (model 1). 

Conclusion: Catheter based renal sympathetic 

denervation can safely be used to substantially 

reduce blood pressure in treatment-resistant hypertensive 

patients. Based on current pricing of 

equipment for RSD and on the performed modelling, 

this new therapeutic approach should be 

considered in patients with treatment resistant 

hypertension lasting between 2.5 years (model 

2) and/or 7 years (model 1). Our results confirm 

that RSD should be indicated only in truly resistant 

hypertensives, and decision should be made 

only by experienced hypertensiologists.

The frequency of administration of antipsychotics, anxiolytics and 

antidepressants: description study 

Svjetlana Loga-Zec 1 , Damir Celik 2 , Faris Gavrankapetanović 2 , Jasmina Krehić 2 , 

Mensura Aščerić 3 , Nedžad Mulabegović 1 

1 Institute of Pharmacology, Clinical Pharmacology 

and Toxicology, Faculty of Medicine, University of 

Sarajevo, Bosnia and Herzegovina 

2 Clinical Centre of the University Sarajevo, Bosnia 


3 Department for pharmacology and toxicology, 

Faculty of Medicine, University of Tuzla, Bosnia and 

Herzegovina 

Goal: To determine the frequency of administration 

of antipsychotics, anxiolytics and antidepressants 

at the Clinical Center University of 

Sarajevo (KCUS), within the Mental Health Care 

Policy in the Federation of Bosnia and Herzegovina. 

Materials and methods: A retrospective study 

was conducted for the period 2009-2011 and as 

a source of data we used databases of Pharmacy 

of KCUS. The descriptive statistics was used, 

counts and percentages were reported. Statistical 

analysis was performed by using the SPSS 19.0 

software. 

Results: The total number of administrated antipsychotics 

in 2009 was 33 637, in 2010 and 2011 

was higher (59 593 and 54 973; respectively). 

The most commonly administered antipsychotics 

were: haloperidol (24.9%), sulpiride (24.1%), 

promazine (20.4%), chlorpromazine (17.5%), 

levomepromazine (11.1%), risperidone (1.3%) 

and fluphenazine (0.7%). The total number of 


P 15 

administrated anxiolytics in 2009 was 18 500, 

in 2010 and 2011 was twice higher (37 930 and 

40 910; respectively). Out of the total number of 

administrated anxiolytics, the most commonly 

administered were: midazolam (41.6%), nitrazepam 

(32.0%), alprazolam (22.6%), bromazepam 

(3.3%), and diazepam (0.5%). The total number 

of administrated antidepressants in 2009 was 14 

762, in 2010 and 2011 was almost twice higher 

(28 552 and 27 846; respectively). The most commonly 

administered antidepressants were: sertraline 

(32.5%), paroxetine (27.8%), fluoxetine 

(20.1%), amitriptiline (8.9%), clomipramine 

(8.2%), and maprotiline (2.5%). 

Conclusion: The rational usage of psychotropic 

medicines requires multiple strategies such as 

psychosocial interventions and the existence of 

Mental Health Care\’s policy formulation to define 

goals related to participation of patients and 

doctors in decision making processes in order to 

improve the usage of psychotropic medicines. 

61

P 16 

Financial impact of imported unapproved drugs on the hospital budget: 

example of the Children’s Hospital of the University Hospital Centre Rijeka, 

Croatia 

Vesna Rosović-Bazijanac, Jasenka Mršić-Pelčić, Dinko Vitezić 

University Hospital Centre Rijeka and University of 

Rijeka Medical School, Croatia 

Goal: The aim of our study is to analyse the financial 

impact on the hospital budget of imported 

drugs (“interventional import”), not approved 

in Croatia. 

Materials and methods: The data were collected 

from the Pharmacy of the Children’s Hospital 

of the University Hospital Centre Rijeka during 

2011. This is a hospital with120 beds, treating 

population to 18 years of age. Descriptive 

analyses were performed and the financial data 

are presented in Euros (€) regarding the whole 

amount of purchased drugs. We classified drugs 

into three groups i.e. the first group are drugs 

included on the Hospital drug list (HDL) of the 

Croatian National Health Insurance under a generic 

name, the second group are the necessary 

drugs which are not on the HDL, and in the third 

group are parenteral solutions which are now 

imported, but previously made in the Hospital 

Pharmacy. 

Results: The Children’s hospital treatment includes 

13.21% of drugs which are not approved, 

but are now imported as necessary for treatment 

and the total cost is 101,306.20 €. Top five drugs 

in the first group (35 in total) are asparaginase, 


pulmonary surfactants, cefotaxime, cloxacillin 

and ampicillin and the total cost is 70,818.17 €, 

which is 9.24% of total costs. The second group 

includes 42 drugs (the first five are sodium phenylbutyrate, 

gonadorelin, nystatin, colistin and allergens 

for Prick testing) and the total cost was 

30,488.03 € (3.98% of total cost). The third group 

includes magnesium sulphate 20% (now 50%), 

glucose 25 and 50% (now 40%), sodium benzoate 

10% (now sodium phenylbutyrate), sodium 

chloride 5.84% (now 10%) and potassium chloride 

7.45%. Our analysis shows that the average 

price of the imported solutions is approximately 

ten times greater than the one we used to make 

in the Hospital Pharmacy. 

Conclusion: The results show that a considerable 

amount of money is spent on imported unapproved 

drugs, i.e. two monthly drug budgets of 

the Children’s hospital. The process of approval 

is probably expensive and the financial gain for 

pharmaceutical companies could not compensate 

it, but it is necessary to find a new way how 

to make this process easier and prices of imported 

drugs less costly (defined prices).

Malnutrition in Croatia – where are we today and why should we include 

societal perspective in measuring “burden of illness“? 

Ranko Stevanović 1 , Vanesa Benković 1 , Ana Ivičević 1 , Ivana Kolčić 2 , 

Irena Rojnić Palavra 1 

1 Croatian Society for Pharmacoeconomics and 

Health Economics, Zagreb, Croatia 

2 Medical Faculty, University of Split, Split, Croatia 

Goal: to identify current status of health care related 

cost attributable to malnutrition in Croatia. 

To emphasize the importance of concealed societal 

costs in today’s budget holder perspective, to 

set platform model for estimating cost of illness 

in the region. 

Materials and methods: increasing efforts are being 

made to estimate the cost of malnutrition in 

many European countries including setting up 

costing structure based on co morbidities (oncology, 

palliative care, gastroenterology diseases), 

interviews with key opinion leaders, interviews 

with nurses for homecare and other care 

providers. Also, cost of illness methodology and 

interviewing stakeholders in malnutrition diagnostics 

should be used to assess present state and 

tackle societal costs. 

Results and conclusion: Malnutrition is common, 

yet under-recognized and under-treated 

condition in the community, in long-term care 

and in hospitals in Croatia. Untreated malnutrition 

has adverse effects on clinical outcomes 


P 17 

including impaired gastrointestinal, cardiac, pulmonary, 

renal, skin, immune and mental function. 

In clinical practice, malnutrition delays 

recovery from illness or injury, causes muscle 

loss and weakening, increases risk for complications 

such as infections and pressure ulcers, 

predisposes to depression and reduced quality 

of life, and increases risk for death. Overall costs 

for health care can be 2-3 folds higher among 

malnourished patient compared to their nourished 

peers. To be able to fully account for cost 

of malnutrition in Croatia, a societal perspective 

should be maintained 

to enable true values and estimation of costs a 

holistic approach must be taken when considering 

economic evaluation. The costs may be incurred 

in one setting whilst the benefit appears 

in another sector. 

Further one implementation of ‘academic’ guidelines 

and national programs to indentify patients 

at risk is needed to achieve improved outcomes 

and optimal use of resources. 

63

PRVI BOSANSKO-HERCEGOVAČKI I DRUGI 

JADRANSKI KONGRES FARMAKOEKONOMIKE 

I ISTRAŽIVANJA ISHODA LIJEČENJA 

24. - 26. april 2012. 

Sarajevo, Bosna i Hercegovina 

Pokrovitelji kogresa su: 

Ministarstvo zdravlja Republike Hrvatske 

Ministar, Prof.dr. Rajko Ostojić, dr. med. 

Ministarstvo zdravstva Federacije Bosne i Hercegovine 

Ministar, Prof.dr.Rusmir Mesihović, dr.med. 

Ministarstvo zdravlja i socijalne zaštite Republike Srpske 

Ministar, Prof.dr.Ranko Škrbić, dr.med.

Zlatni sponzor 

PFIZER 

Brončani sponzori 

ELI LILLY NOVO NORDISK HEMOFARM 

Sponzor

prvi bosansko-hercegovački i drugi jadranski kongres ...

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