COMPARISON REGARDING THE TRANSPARENCY OF REIMBURSEMENT DECISIONS FOR PHARMACEUTICALS USED TO TREAT DEPRESSION IN HUNGARY, ROMANIA, TURKEY AND CIS

Author(s)

Daneasa D1, Csanadi M2, Baran A3, Subtirelu M4, Preda AL5, Petrescu M5, Pinyazhko O2, Holownia M6, Atikeler EK7
1VUB, Free University of Brussels, Belgium, Brussels, Belgium, 2VUB, Free University of Brussels, Belgium, BRUSSELS, Belgium, 3Medical University of Warsaw, Utrecht, The Netherlands, 4University of Medicine and Pharmacy of Craiova, Craiova, Romania, 5University of Medicine and Pharmacy „Carol Davila”, Bucharest, Romania, 6State Budgetary Institution of Moscow City “Clinical Trials and Healthcare Technology Assessment Scientific-Research Centre of Moscow Department of Healthcare”, Moscow, Russia, 7Turkish Medicines and Medical Devices Agency, Ankara, 06, Turkey

Objectives: Increased transparency with regard to how Central Nervous System (CNS) medication - with a particular emphasis on Depression - is assessed throughout the reimbursement process has several benefits: justifies for previous decisions, may influence reflection on patients needs and gives clear market access criteria for manufacturers. Our objective was to highlight the level of transparency of Drugs used to treat Depression in some European countries: Hungary, Romania as well as neighboring areas such as Turkey and CIS. Methods: We evaluated HTA process for Drugs used to treat Depression (or in general CNS drugs) against a pre-defined scorecard of transparency. Information was obtained from public sources: websites of governmental institutions and official legislations. Evaluation was made on the following six elements: requirements for reimbursement, availability of submitted documents by manufacturers, process of the submissions evaluation or appraisal, recommendations by those who conducted evaluation, final reimbursement decision, follow-up on decisions. Results: In Hungary an HTA guideline and a critical appraisal checklist are available to draw up the basic requirements for reimbursement submissions. However, apart from the final decision no other transparency element is available. In Romania, he current general legislation provides clear timelines and evaluation criteria, in reality, the deadlines are not met. Criteria for evaluation are clearly mentioned in the legislation, but a more clear guidance is still required. In Turkey and CIS, the overall legislation provides clear information for the P&R process. Conclusions: Even if important steps in providing a clear and transparent HTA process for CNS drugs had been established in the legislative framework of the different countries, many areas require improvement. This could be done through clear published submission timeline, closing the gap between evaluation process and actual reimbursement, functional appealing committee and objective criteria are still missing in key points of the evaluation process.

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PCP30

Topic

Health Policy & Regulatory

Disease

Mental Health

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×