80 Folia Medica 2013; 55(3&4): 80-86 Copyright © 2013 Medical University Plovdiv doi: 10.2478/folmed-2013-0032 INSIGHT INTO REIMBURSEMENT DECISION-MAKING CRITERIA IN BULGARIA: IMPLICATIONS FOR ORPHAN DRUGS Georgi G. Iskrov*, Ralitsa D. Raycheva, Rumen S. Stefanov Department of Social Medicine and Public Health, Faculty of Public Health, Medical University of Plovdiv, Bulgaria ABSTRACT OBJECTIVE: This article’s objective is to critically assess the Bulgarian legislation on health technology assessment (HTA). It analyses how innovative therapies and orphan drugs in particular would respond to the regulators’ decision-making criteria for reimbursement. MATERIALS AND МETHODS: The study features critical analysis of current decision-making criteria for drug reimbursement in Bulgaria, as well as hypothetical scenario planning for orphan medicinal products. RESULTS: The approval for inclusion into the Positive Drug List (PDL) (which is a must for reimbursement) has been reorganised into an assessment scoring system with decision- making criteria (presence of therapeutic alternative, clinical effectiveness, safety, pharma- coeconomics and societal value) divided into weighted indicators. An explicit threshold has been set – a medicinal product must score 60 points at least to be included in PDL. Under the currently defined reimbursement decision-making criteria a hypothetical mid- dle-of-the-road scenario planning shows that an orphan drug would score 20 points for therapeutic alternative, 28 for clinical effectiveness and 12 for safety. It would take no points for pharmacoeconomics and societal value. This leaves the orphan drugs with a total score of 60 points, making the final outcome of real-life assessment and decision-making heavily dependent on small fluctuations. CONCLUSIONS: The current reimbursement decision-making framework in Bul- garia seems to be generalised and not sufficiently transparent. It is unable to pre- cisely assess innovative health technologies. The availability of a therapeu- tic alternative emerges as a key reimbursement decision-making criterion for orphan drugs, as these innovative products nominally provide the first medicinal therapy alternative to rare diseases. Key words: orphan drugs, health technology assessment, reimbursement, decision-making criteria, Bulgaria INTRODUCTION Greater public awareness of health care rationing decisions and growing consumerist position on health care policy require more accountability, transparency and legitimacy in the decision-making process. De- cision-makers need a more comprehensive approach to set priorities and obtain maximum benefit from limited resources, without compromising the ethi- cal and social values underpinning health systems. 1 Bulgaria has only recently started officially im- plementing these ideas in reimbursement decision- taking and the country still lacks experience and expertise. Nevertheless, economic and societal reali- ties obligate a strategic approach to health technol- ogy assessment (HTA) concepts. In Bulgaria, the Ordinance for regulation and registration of prices of medicinal products, conditions, procedures and criteria for inclusion, amendments and/or exclusion of medicinal products from the Positive Drug List (PDL) and the terms and conditions for work of the Drug Pricing and Reimbursement Committee has been considerably amended to provide a more sophisticated and more efficient base for reimburse- ment decisions. 2 This piece of legislation is the *Correspondence and reprint request to: G. Iskrov, Department of Social Medicine and Public Health, Faculty of Public Health, Medical University of Plovdiv; E-mail: iskrov@raredis.org; Mob.: +359 888 940 029 15A Vassil Aprilov St., 4002 Plovdiv, Bulgaria Received 9 September 2013; Accepted for publication 11 November 2013 Public Health Care Unauthenticated | 87.119.68.242 Download Date | 3/14/14 9:15 AM