Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries.Methods:A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017.Results:The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application.Conclusions:Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries.

Croatian Agency for Medicinal Products and Medical Devices Zagreb Croatia

Departament of Pathology Forensic Medicine and Pharmacology Vilnius University Vilnius Lithuania State Medicine Control Agency Vilnius Lithuania

Department of Organization and Management in Pharmacy Faculty of Pharmacy Comenius University in Bratislava Bratislava Slovakia

Faculty of Pharmacy Medical University of Sofia Sofia Bulgaria

Faculty of Pharmacy University of Medicine and Pharmacy of Craiova Craiova Romania

Health Sciences Faculty Institute of Public Health Jagiellonian University Medical College Kraków Poland

Health Sciences Faculty Institute of Public Health Jagiellonian University Medical College Kraków Poland Departament of Neurobiology Institute of Pharmacology Polish Academy of Sciences Krakow Poland

Health Technology Assessment Department Pricing and Reimbursement Regulation Branch State Institute for Drug Control Prague Czechia

Institute of Family Medicine and Public Health University of Tartu Tartu Estonia

National Institute of Health Insurance Fund Management Budapest Hungary Department of Health Policy and Health Economics Eötvös Loránd University Budapest Hungary

Syreon Research Institute Budapest Hungary

The National Health Service Ministry of Health Riga Latvia

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$a Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries.Methods:A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017.Results:The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application.Conclusions:Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries.

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$a Tesar, Tomas $u Department of Organization and Management in Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovakia.

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$a Vostalova, Lenka $u Health Technology Assessment Department, Pricing and Reimbursement Regulation Branch, State Institute for Drug Control, Prague, Czechia.

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$a Männik, Agnes $u Institute of Family Medicine and Public Health, University of Tartu, Tartu, Estonia.

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$a Sowada, Christoph $u Health Sciences Faculty, Institute of Public Health, Jagiellonian University Medical College, Kraków, Poland.

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$a Harsanyi, Andras $u National Institute of Health Insurance Fund Management, Budapest, Hungary. Department of Health Policy and Health Economics, Eötvös Loránd University, Budapest, Hungary.

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$a Inotai, Andras $u Syreon Research Institute, Budapest, Hungary.

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$a Turcu-Stiolica, Adina $u Faculty of Pharmacy, University of Medicine and Pharmacy of Craiova, Craiova, Romania.

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$a Gulbinovič, Jolanta $u Departament of Pathology, Forensic Medicine and Pharmacology, Vilnius University, Vilnius, Lithuania. State Medicine Control Agency, Vilnius, Lithuania.

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$a Pilc, Andrzej $u Health Sciences Faculty, Institute of Public Health, Jagiellonian University Medical College, Kraków, Poland. Departament of Neurobiology, Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland.

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