Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review

Frontiers in Pharmacology

Andras Inotai¹  Adina Turcu-Stiolica²  Jolanta Gulbinovič⁴  Andrzej Pilc⁵  Pero Draganic⁶  Andras Harsanyi⁷  Tomas Tesar⁸  Manoela Manova⁹  Alexandra Savova⁹  Guenka Petrova⁹  Christoph Sowada^1,10  Paweł Kawalec^1,10  Ewa Stawowczyk^1,10  Lenka Vostalova^1,11  Agnes Männik^1,12  Zinta Rugaja^1,14 

[1] 0Syreon Research Institute, Budapest, Hungary;1Faculty of Pharmacy, University of Medicine and Pharmacy of Craiova, Craiova, Romania;2Departament of Pathology, Forensic Medicine and Pharmacology, Vilnius University, Vilnius, Lithuania;3State Medicine Control Agency, Vilnius, Lithuania;4Departament of Neurobiology, Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland;Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia;Department of Health Policy and Health Economics, Eötvös Loránd University, Budapest, Hungary;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;Health Sciences Faculty, Institute of Public Health, Jagiellonian University Medical College, Kraków, 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;The National Health Service, Ministry of Health, Riga, Latvia;

关键词: pricing;    reimbursement;    CEE;    pharmaceutical regulation;    drug policy;   

DOI  :  10.3389/fphar.2017.00892

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown