Access to orphan drugs – comparison across Balkan countries |
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| Institution: | 1. Faculty of Medical Sciences, University of Kragujevac, Svetozara Markovica 69, 34000 Kragujevac, Serbia;2. Department of Social Medicine and Public Health, Faculty of Public Health, Medical University of Plovdiv, Vasil Aprilov 15 A Blvd, 4002 Plovdiv, Bulgaria;3. Institute for Rare Diseases, Maestro Georgi Atanasov 22 Str, 4023 Plovdiv, Bulgaria;4. Health Economics and Pharmacoeconomics, Faculty of Medical Sciences, University of Kragujevac, Svetozara Markovica 69, 34000 Kragujevac, Serbia;1. Internal Medicine/Allergy/Immunology Division, University of Texas Southwestern Medical School, Dallas, TX, USA;2. AARA Research Associates, Private Practice, 10100 North Central Expressway, Suite 100, Dallas, TX 75231, USA;1. Department of Social Policy, London School of Economics and Political Science, United Kingdom;2. LSE Health, London School of Economics and Political Science, United Kingdom;1. Institute for Innovation and Valuation in Health Care, Wiesbaden, Germany;2. German Cancer Research Center, University of Heidelberg, Heidelberg, Germany;3. Institute for Health Services Research and Health Economics, Medical Faculty Heinrich-Heine University Düsseldorf, Düsseldorf, Germany;4. Frankfurt School of Finance and Management, Frankfurt, Germany;1. Department of Social Policy, LSE Health, London School of Economics and Political Science, London, UK;2. Center for Research on Health and Social Care Management, Bocconi University, Milan, Italy;3. Université Paris Est Créteil Val de Marne (UPEC), Créteil, France;4. URC Eco Ile-de-France (AP-HP), Paris, France;5. ECEVE UMRS 1123, UEC—Hôpital Robert Debré (AP-HP), Paris, France |
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| Abstract: | The aim of this study was to compare orphan drug access in a sample of Balkan countries: five EU Member States (Bulgaria, Croatia, Greece, Romania, Slovenia) and two EU Candidates (Serbia, Montenegro). The comparative analysis was based on a cross-sectional study and included medicinal products with an active orphan designation and market authorisation on January 1, 2017.Access to orphan drugs is an ongoing challenge in these countries. Three clusters of countries were identified in terms of orphan drug access: Greece and Slovenia, making the top tier, Romania, Bulgaria, and Croatia, being in the middle, and EU Candidates, Serbia and Montenegro, forming the bottom tier, where a substantial number of EU market approved orphan drugs was not even registered. Available public health resources and market size are probably among the contributing factors for such inequalities. Sizeable part of EMA market authorised orphan medicinal products is not even priced in the Balkan countries. This is a serious issue, which is putting rare disease patients from this region in a particularly vulnerable situation.There is a need for further improvement in accessibility of orphan drugs in the Balkan countries. Cross-border collaboration in the field of pricing, health technology assessment, and reimbursement negotiation of orphan drugs may help to address these challenges. |
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| Keywords: | Orphan drugs Rare diseases Access Pricing Reimbursement The Balkans |
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