COMPARISON OF THE REIMBURSEMENT DECISIONS OF PHARMACEUTICALS IN HUNGARY, ROMANIA AND TURKEY

Author(s)

Atikeler K1, Csanadi M2, Subtirelu M3, Baran A4, Daneasa D5, Preda AL6, Petrescu M6, Akyurek CE7
1Turkish Medicines and Medical Devices Agency, Ankara, Turkey, 2University of Pécs, Pécs, Hungary, 3University of Medicine and Pharmacy, Craiova, Romania, 4Akademia Leona Kozminiskiego Utrecht Area, Utrecht, The Netherlands, 5VUB, Free University of Brussels, Belgium, BRUSSELS, Belgium, 6University of Medicine and Pharmacy „Carol Davila”, Bucharest, Romania, 7Ankara University, Ankara, Turkey

OBJECTIVES: In countries with strong financial constraints healthcare decision-makers often restrict patient access to new medicines. In addition, manufacturers may delay their lunch due to undesired nature of these markets. We aimed to compare the reimbursed status of newly registered pharmaceuticals in three selected countries.

METHODS: Drugs registered in 2015 by EMA were listed and published national databases about drug reimbursement were reviewed. In Hungary, the National Health Insurance Fund Administration publishes a regularly updated list of drugs that applied for reimbursement. In Romania, the process of access to innovative medicines is organized in 3 steps: first the drug is registered based on EMA procedure, second the dossier is filed at MoH with the Romanian price, and finally, it can be sold, but not yet reimbursed by the public payers. Process of reimbursement decisions are lack of transparency. In Turkey, Turkish Medicines and Medical Devices Agency (TMMDA) responsible for registration and pricing process of drugs and Social Security Institution (SSI) takes reimbursement submissions and decisions. SSI only publishes positive decisions.

RESULTS: registered products were reviewed in the national databases. In Hungary, 17 of the reviewed products were on the public reimbursement list, 3 received negative reimbursement decisions and 10 are awaiting for decision about their reimbursement application. In Romania, only 5 of the listed products are on the positive reimbursement list. In Turkey 63, of the listed products are not on the reimbursement list but 8 of them can be reimbursed upon approval of TMMDA by patient case (this case products imported from abroad) and 19 received positive reimbursement decision

CONCLUSIONS: We found similarities among Hungary and Turkey in the number of reimbursed drugs and more than half of the reimbursed products (10) were same in the two countries. Romania, however faces serious constrains in terms of patient access to newly approved drugs.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PHP250

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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