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Pricing and Reimbursement of Patent-Protected Medicines: Challenges and Lessons from South-Eastern Europe

Author

Listed:
  • Luka Vončina

    (University of Rijeka)

  • Tea Strbad

    (Croatian Health Insurance Fund)

  • Jurij Fürst

    (Health Insurance Institute of Slovenia)

  • Maria Dimitrova

    (Medical University of Sofia)

  • Maria Kamusheva

    (Medical University of Sofia)

  • Megi Vila

    (F. Hoffmann, La Roche)

  • Ileana Mardare

    (“Carol Davila” University of Medicine and Pharmacy)

  • Kristina Hristova

    (Health Insurance Fund)

  • Andras Harsanyi

    (Eotvos Lorand University)

  • Dragana Atanasijević

    (Institute of Public Health of Serbia)

  • Igor Banović

    (University of Rijeka)

  • Ana Bobinac

    (University of Rijeka)

Abstract

Background Efficiency and transparency of pricing and reimbursement (P&R) rules and procedures as well as their implementation in South-eastern Europe (SEE) lag substantially behind Western European practice. Nevertheless, P&R systems in SEE are rarely critically assessed, warranting a detailed and wider-encompassing exploration. Objective Our study provides a comparative assessment of P&R processes for patent-protected medicines in ten SEE countries—EU member states: Croatia, Slovenia, Hungary, Romania and Bulgaria; and non-EU countries: Albania, Montenegro, Serbia, North Maceodina, Bosnia and Herzegovina. P&R systems are compared and evaluated through a research framework that focuses on: (1) public financing of patent-protected medicines, (2) definition of benefit packages, (3) requirements for the submission of reimbursement dossiers, (4) assessment and appraisal processes, (5) reimbursement decision making, (6) processes that occur post reimbursement, and (7) pricing. The study aims to contribute to the discussion on improving the efficiency and quality of P&R of patent-protected medicines in the region. Methods We conducted a non-systematic literature review of published literature, as well as policy briefs and reports on healthcare systems in the SEE region along with legal documents framing the P&R procedures in local languages. The information gathered from these various sources was then discussed and clarified through structured telephone interviews with relevant national experts from each SEE country, mainly current and former senior officials and/or executives of the funding and assessment/ appraisal bodies (total of 20 interviews conducted in late 2019). Results Capacity building through sharing knowledge and information on successful reforms across borders is an opportunity for SEE countries to further develop their P&R policies and increase (equitable) access to patent-protected medicines (especially expensive medicines), increasing affordability and containing costs. Simple yet robust and systematic decision-making frameworks that rely on international health technology assessment (HTA) procedures and are based on the pursuit of transparency seem to be the most cost-effective approach to strengthening P&R systems in SEE. Conclusions Further reforms aiming to develop transparent and robust national decision-making frameworks (including oversight) and build institutional HTA-related and decision-making capacity are awaited in most of SEE countries, especially the non-EU members. In non-EU SEE countries, these efforts could increase access to patent-protected medicines, which is—at the moment—very limited. The EU-member SEE countries operate more developed P&R systems but could further benefit from developing their procedures, oversight and value-for-money assessment toolbox and capacity, hence further improving the transparency and efficiency of procedures that regulate access to patent-protected medicines.

Suggested Citation

  • Luka Vončina & Tea Strbad & Jurij Fürst & Maria Dimitrova & Maria Kamusheva & Megi Vila & Ileana Mardare & Kristina Hristova & Andras Harsanyi & Dragana Atanasijević & Igor Banović & Ana Bobinac, 2021. "Pricing and Reimbursement of Patent-Protected Medicines: Challenges and Lessons from South-Eastern Europe," Applied Health Economics and Health Policy, Springer, vol. 19(6), pages 915-927, November.
  • Handle: RePEc:spr:aphecp:v:19:y:2021:i:6:d:10.1007_s40258-021-00678-w
    DOI: 10.1007/s40258-021-00678-w
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    References listed on IDEAS

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    1. Vogler, Sabine & Paris, Valérie & Ferrario, Alessandra & Wirtz, Veronika J. & Joncheere, Kees de & Schneider, Peter & Pedersen, Hanne Bak & Dedet, Guillaume & Babar, Zaheer-Ud-Din, 2017. "How can pricing and reimbursement policies improve affordable access to medicines? Lessons learned from European countries," LSE Research Online Documents on Economics 68862, London School of Economics and Political Science, LSE Library.
    2. Garattini, Livio & Cornago, Dante & De Compadri, Paola, 2007. "Pricing and reimbursement of in-patent drugs in seven European countries: A comparative analysis," Health Policy, Elsevier, vol. 82(3), pages 330-339, August.
    3. Sabine Vogler & Valérie Paris & Alessandra Ferrario & Veronika J. Wirtz & Kees Joncheere & Peter Schneider & Hanne Bak Pedersen & Guillaume Dedet & Zaheer-Ud-Din Babar, 2017. "How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries," Applied Health Economics and Health Policy, Springer, vol. 15(3), pages 307-321, June.
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