Claessens Zilke, Lammens Michiel, Barbier Liese, Huys Isabelle
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.
J Mark Access Health Policy. 2024 Jul 9;12(3):144-157. doi: 10.3390/jmahp12030012. eCollection 2024 Sep.
National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria, and Ireland that aims to address sustainable access to medicines. In view of the soon-to-be-implemented EU HTA Regulation, insights and experiences from stakeholders with Beneluxa cross-country collaboration could provide possible transferable learnings. Therefore, this research aims to (i) identify the opportunities and challenges faced by Beneluxa, (ii) gather insights from stakeholders, namely (possible) applicants and policymakers, within and beyond Beneluxa on the initiative and broader cross-country collaboration principles, and (iii) transfer these insights into learnings and recommendations in anticipation of the full implementation of the new HTA Regulation. Fifteen semi-structured interviews were conducted with industry and European HTA/policy stakeholders. The principal challenges discussed by stakeholders encompass hesitancy from the industry toward Beneluxa assessments, which were attributed to procedural and timeline uncertainties, legislative framework ambiguity, and challenges in terms of industry's internal organization. Another challenge highlighted is the resource-intensive nature of the procedure due to diverse approaches among member states. In addition, industry stakeholders mentioned limited communication and procedural complexity. Despite challenges, both stakeholder groups recognized important opportunities for cross-country collaboration. Transferable insights for future cross-country collaboration include transparent communication, clear legislative embedding, internal industry restructuring to facilitate joint HTAs, and member state support for conducting collaborative assessments. The study underscores diverging views among stakeholders on cross-country collaboration's potential to support HTA and the market access of complex health technologies. While acknowledging benefits, there still are challenges, including industry hesitancy, emphasizing the need for transparent communication and clear guidance in the evolving EU HTA landscape.
国家定价和报销机构在面对复杂的医疗技术时面临着越来越多的挑战，这促使欧洲出台政策改进措施。比荷卢联盟是一项涉及比利时、荷兰、卢森堡、奥地利和爱尔兰的跨国合作，旨在解决药品的可持续可及性问题。鉴于即将实施的欧盟卫生技术评估法规，比荷卢联盟跨国合作中利益相关者的见解和经验可能会提供可借鉴的经验。因此，本研究旨在：（i）确定比荷卢联盟面临的机遇和挑战；（ii）收集利益相关者的见解，即比荷卢联盟内外的（潜在）申请者和政策制定者对比荷卢联盟倡议及更广泛的跨国合作原则的见解；（iii）在新的卫生技术评估法规全面实施之前，将这些见解转化为经验教训和建议。对行业和欧洲卫生技术评估/政策利益相关者进行了15次半结构化访谈。利益相关者讨论的主要挑战包括行业对比荷卢联盟评估的犹豫，这归因于程序和时间线的不确定性、立法框架的模糊性以及行业内部组织方面的挑战。另一个突出的挑战是由于成员国之间的不同方法，该程序资源密集。此外，行业利益相关者提到沟通有限和程序复杂。尽管存在挑战，但两个利益相关者群体都认识到跨国合作的重要机遇。未来跨国合作的可借鉴见解包括透明沟通、明确的立法嵌入、促进联合卫生技术评估的行业内部重组以及成员国对进行合作评估的支持。该研究强调了利益相关者对跨国合作支持卫生技术评估和复杂医疗技术市场准入潜力的不同看法。虽然承认有好处，但仍然存在挑战，包括行业犹豫，这强调了在不断发展的欧盟卫生技术评估环境中进行透明沟通和明确指导的必要性。
