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

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 expert...

Full description

Saved in:
Bibliographic Details
Main Authors: Paweł Kawalec (Author), Tomas Tesar (Author), Lenka Vostalova (Author), Pero Draganic (Author), Manoela Manova (Author), Alexandra Savova (Author), Guenka Petrova (Author), Zinta Rugaja (Author), Agnes Männik (Author), Christoph Sowada (Author), Ewa Stawowczyk (Author), Andras Harsanyi (Author), Andras Inotai (Author), Adina Turcu-Stiolica (Author), Jolanta Gulbinovič (Author), Andrzej Pilc (Author)
Format: Book
Published: Frontiers Media S.A., 2017-12-01T00:00:00Z.
Subjects:
Online Access:Connect to this object online.
Tags: Add Tag
No Tags, Be the first to tag this record!

MARC

LEADER 00000 am a22000003u 4500
001 doaj_b0fa5d3837f14a2fbbb05e49a187068d
042 |a dc 
100 1 0 |a Paweł Kawalec  |e author 
700 1 0 |a Tomas Tesar  |e author 
700 1 0 |a Lenka Vostalova  |e author 
700 1 0 |a Pero Draganic  |e author 
700 1 0 |a Manoela Manova  |e author 
700 1 0 |a Alexandra Savova  |e author 
700 1 0 |a Guenka Petrova  |e author 
700 1 0 |a Zinta Rugaja  |e author 
700 1 0 |a Agnes Männik  |e author 
700 1 0 |a Christoph Sowada  |e author 
700 1 0 |a Ewa Stawowczyk  |e author 
700 1 0 |a Andras Harsanyi  |e author 
700 1 0 |a Andras Harsanyi  |e author 
700 1 0 |a Andras Inotai  |e author 
700 1 0 |a Adina Turcu-Stiolica  |e author 
700 1 0 |a Jolanta Gulbinovič  |e author 
700 1 0 |a Jolanta Gulbinovič  |e author 
700 1 0 |a Andrzej Pilc  |e author 
700 1 0 |a Andrzej Pilc  |e author 
245 0 0 |a Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review 
260 |b Frontiers Media S.A.,   |c 2017-12-01T00:00:00Z. 
500 |a 1663-9812 
500 |a 10.3389/fphar.2017.00892 
520 |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. 
546 |a EN 
690 |a pricing 
690 |a reimbursement 
690 |a CEE 
690 |a pharmaceutical regulation 
690 |a drug policy 
690 |a Therapeutics. Pharmacology 
690 |a RM1-950 
655 7 |a article  |2 local 
786 0 |n Frontiers in Pharmacology, Vol 8 (2017) 
787 0 |n http://journal.frontiersin.org/article/10.3389/fphar.2017.00892/full 
787 0 |n https://doaj.org/toc/1663-9812 
856 4 1 |u https://doaj.org/article/b0fa5d3837f14a2fbbb05e49a187068d  |z Connect to this object online.