Faculty of Health Studies, University of Rijeka, Rijeka, Croatia.
Croatian Health Insurance Fund, Zagreb, Croatia.
Appl Health Econ Health Policy. 2021 Nov;19(6):915-927. doi: 10.1007/s40258-021-00678-w. Epub 2021 Sep 23.
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.
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.
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).
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.
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.
在东南欧（SEE），定价和报销（P&R）规则的效率和透明度及其实施情况与西欧的实践有很大差距。尽管如此，SEE 的 P&R 系统很少受到严格评估，因此需要进行详细和更全面的探索。
我们的研究通过一个研究框架对 10 个 SEE 国家（欧盟成员国：克罗地亚、斯洛文尼亚、匈牙利、罗马尼亚和保加利亚；非欧盟国家：阿尔巴尼亚、黑山、塞尔维亚、北马其顿、波斯尼亚和黑塞哥维那）的专利保护药品的 P&R 流程进行了比较评估。该研究框架侧重于以下方面：（1）专利保护药品的公共融资，（2）受益范围的定义，（3）报销文件提交的要求，（4）评估和评估流程，（5）报销决策，（6）报销后发生的流程，以及（7）定价。本研究旨在为提高该地区专利保护药品的 P&R 效率和质量的讨论做出贡献。
我们对 SEE 地区医疗保健系统的已发表文献、政策简报和报告，以及以当地语言制定 P&R 程序的法律文件进行了非系统性文献回顾。然后，通过与来自每个 SEE 国家的相关国家专家进行结构化电话访谈，对从这些各种来源收集到的信息进行讨论和澄清，这些专家主要是当前和前任资金和评估/评估机构的高级官员和/或管理人员（2019 年底共进行了 20 次访谈）。
通过跨境共享成功改革的知识和信息进行能力建设，是 SEE 国家进一步发展其 P&R 政策和增加（公平）获得专利保护药品（特别是昂贵药品）的机会，提高可负担性并控制成本。简单而强大且系统的决策框架，依赖于国际卫生技术评估（HTA）程序，并基于对透明度的追求，似乎是加强 SEE 国家 P&R 系统的最具成本效益的方法。
大多数 SEE 国家，特别是非欧盟成员国，都期待进一步改革，以制定透明和强大的国家决策框架（包括监督），并建立机构相关的 HTA 和决策能力。在非欧盟 SEE 国家，这些努力可以增加对专利保护药品的获取，目前这种获取非常有限。欧盟成员国 SEE 国家的 P&R 系统更加发达，但可以进一步受益于其程序、监督和物有所值评估工具包和能力的发展，从而进一步提高监管专利保护药品获取的程序的透明度和效率。
