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

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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.

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Notes

  1. Slovenia and Hungary joined the EU in 2004, Bulgaria and Romania in 2007, Croatia in 2013.

  2. Twenty local experts in total from ten SEE countries.

  3. Due to their significant input in clarifying the particulars of each P&R process and the related “grey area”, the majority of the interviewed experts are also included as co-authors in this final report.

  4. Bosnia and Herzegovina consist of two entities – the Federation of Bosnia and Herzegovina or FBiH, and the Republika Srpska or RepS. Both govern their own separate P&R policies and processes (along with their own health insurance systems, healthcare providers, etc.).

  5. Bulgaria, Republic of Srpska and North Macedonia have or have recently created strategic documents dealing with drug policies.

  6. For example, in FBiH, North Macedonia, Albania and Serbia patients access patent-protected medicines through dedicated MoH “project funds” so that the de facto reimbursement of these medicines (as a rule, expensive patent-protected medicines) bypasses the usual P&R procedures and relies to a great extent on the political will of decision-makers. Given that the funds are very limited (especially for expensive hospital medicines), patients are often informally prioritized on the bases of age (children), time of request (first-come first-served) and geographical representation. Informal criteria may also play a role.

  7. Committee members are rarely full-time employees of the institution in charge of appraisal (e.g., in Croatia, one HIF committee member is a full-time employee of HIF) and serve only for relatively short periods of time during which they continue performing their full-time duties in hospital clinics and other (healthcare) institutions, resulting in poor development of in-house institutional experience.

  8. There are notable exceptions. In this case, the Slovenian Health Insurance Fund’s Committee for Medicines publishes the minutes of its committee sessions on the HIF’s website. These contain detailed recommendations on all submitted medicines. Recommendations are also delivered to companies. Recommendations are well elaborated, primarily focusing on clinical benefit versus requested prices compared to already-listed medicines and cost-effectiveness considerations. Companies can submit additional arguments and evidence if not satisfied with committee recommendations.

  9. The Slovenian Health Insurance Fund’s Committee for Medicines publishes the minutes of its committee sessions on the HIF’s website. These contain detailed recommendations on all submitted medicines. Recommendations are also delivered to companies. Recommendations are well elaborated, primarily focusing on clinical benefit versus requested prices compared to already-listed medicines and cost-effectiveness considerations. Companies can submit additional arguments and evidence if not satisfied with committee recommendations.

  10. Except in the Republic of Srpska (Bosnia and Herzegovina) where the HIF's management board is in charge.

  11. Hungary has taken the greatest steps towards developing the HTA framework. In 2002, the Hungarian Ministry of Health released its first guidelines for conducting health economic analyses in the SEE region. The Hungarian Health Economics Association, now ISPOR Hungary chapter, was established in 2003. The association publishes methodological articles in the field of health economics, most notably the Hungarian Pharmacoeconomic Guideline that was first published in 2003 and was revised in 2013 and 2016. The guideline gives an in-depth description of the requirements on conducting HTA analysis in Hungary. It also sets an explicit cost-effectiveness threshold at three times the annual GDP per capita. Furthermore, it highlights that HTA analyses should be adapted to the Hungarian settings and should follow the Hungarian Pharmacoeconomic Guideline as much as possible.

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Acknowledgements

We kindly thank the reviewers for their valuable comments, which significantly improved the paper and to Bartalan Nemeth for providing insight on pricing and reimbursement of medicines in Hungary.

Author information

Authors and Affiliations

  1. Faculty of Health Studies, University of Rijeka, Rijeka, Croatia

    Luka Vončina

  2. Croatian Health Insurance Fund, Zagreb, Croatia

    Tea Strbad

  3. Health Insurance Institute of Slovenia, Ljubljana, Slovenia

    Jurij Fürst

  4. Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria

    Maria Dimitrova & Maria Kamusheva

  5. F. Hoffmann, La Roche, Tirana, Albania

    Megi Vila

  6. “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania

    Ileana Mardare

  7. Health Insurance Fund, Skopje, Republic of North Macedonia

    Kristina Hristova

  8. Eotvos Lorand University, Budapest, Hungary

    Andras Harsanyi

  9. Institute of Public Health of Serbia, Belgrade, Serbia

    Dragana Atanasijević

  10. Faculty of Economics and Business, Center for Health economics and Pharmacoeconomics (CHEP), University of Rijeka, Ivana Filipovića 4, 51000, Rijeka, Croatia

    Igor Banović & Ana Bobinac

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  1. Luka Vončina
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Correspondence to Ana Bobinac.

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Authors' contributions

Luka Vončina and Ana Bobinac made substantial contributions to the conception or design of the work, and the acquisition, analysis and interpretation of data. Luka Vončina, Tea Strbad, Jurij Fürst, Maria Dimitrova, Maria Kamusheva, Megi Vila, Ileana Mardare, Kristina Hristova, Andras Harsanyi, Dragana Atanasijević, Igor Banović and Ana Bobinac participated in drafting the paper or revised it critically for important intellectual content as well as approved the final version to be published. All authors agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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The work of Ana Bobinac and Igor Banović is partly supported by the Croatian Science Foundation under the project UIP-2019-04-3721 and the European Union from the European Social Fund under the project Health Observatory (UP.04.2.1.06.0045).

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Vončina, L., Strbad, T., Fürst, J. et al. Pricing and Reimbursement of Patent-Protected Medicines: Challenges and Lessons from South-Eastern Europe. Appl Health Econ Health Policy 19, 915–927 (2021). https://doi.org/10.1007/s40258-021-00678-w

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