WHAT IS THE LEVEL OF TRANSPARENCY IN HEALTH TECHNOLOGY ASSESSMENT PROCESS IN HUNGARY, ROMANIA AND TURKEY?

Author(s)

Subtirelu M1, Mic OC1, Daneasa D2, Csanadi M3, Atikeler K4, Dogan E4, Preda AL5
1University of Medicine and Pharmacy, Craiova, Romania, 2VUB, Free University of Brussels, Brussels, Belgium, 3Syreon Research Institute, Budapest, Hungary, 4Hacettepe University, Ankara, Turkey, 5University of Medicine and Pharmacy „Carol Davila”, Bucharest, Romania

OBJECTIVES: Transparency 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 in 3 European countries: Hungary, Romania, Turkey. METHODS:  We evaluated HTA process 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, the legislation provides clear timelines and evaluation criteria, in reality, the deadlines are not met. Criteria for evaluation are clearly mentioned in the legislation, but evaluation process like budget impact evaluation still needs a clear guidance. Final evaluations reports are not published in 3 months as stated in the legislation and do not guarantee immediate reimbursement. In Turkey,legislation provides clear information for both pricing and reimbursement process, however HTA is not key element for reimbursement decision. Deadlines are clearly stated, but due to drug budget some delays may seen during evaluation process. Evaluation report include short information of decision and generally consider budget impact. CONCLUSIONS:  Even if important steps in providing a clear and transparent HTA process had been established in the legislative framework of the 3 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

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHS178

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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