Department of Science,Division of Pharmacoepidemiology and Clinical Pharmacology,Utrecht
Center for Innovation in Regulatory Science.
Int J Technol Assess Health Care. 2017 Jan;33(3):350-357. doi: 10.1017/S0266462317000563. Epub 2017 Jul 19.
The objective of this study is to illustrate and provide a better understanding of the role of health technology assessment (HTA) processes in decision making for drug reimbursement in Poland and how this approach could be considered by other countries of limited resources.
We analyzed the evolution of the HTA system and processes in Poland over the past decade and current developments based on publicly available information.
The role of HTA in drug-reimbursement process in Poland has increased substantially over the recent decade, starting in 2005 with the formation the Agency for Health Technology Assessment and Tariff System (AOTMiT). The key success factors in this development were effective capacity building based on the use of international expertise, the implementation of transparent criteria into the drug reimbursement processes, and the selective approach to the adoption of innovative medicines based on the cost-effectiveness threshold among other criteria.
While Poland is regarded as a leader in Central and Eastern Europe, there is room for improvement, especially with regard to the quality of HTA processes and the consistency of HTA guidelines with reimbursement law. In the "pragmatic" HTA model use by AOTMiT, the pharmaceutical company is responsible for the preparation of a reimbursement dossier of good quality in line with HTA guidelines while the assessment team in AOTMiT is responsible for critical review of that dossier. Adoption of this model may be considered by other countries with limited resources to balance differing priorities and ensure transparent and objective access to medicines for patients who need them.
本研究旨在阐述并更好地理解卫生技术评估(HTA)在波兰药品报销决策中的作用,以及这种方法如何为资源有限的其他国家所借鉴。
我们分析了过去十年中波兰 HTA 系统和流程的演变以及当前的发展情况,这些信息均来自公开资料。
在过去十年中,波兰 HTA 在药品报销过程中的作用显著增强,这一趋势始于 2005 年成立卫生技术评估和定价系统机构(AOTMiT)。这一发展的关键成功因素是基于国际专业知识的有效能力建设,将透明标准纳入药品报销流程,以及根据成本效益阈值等其他标准,对创新药物采取选择性的采用方法。
尽管波兰被视为中东欧的领导者,但仍有改进的空间,尤其是在 HTA 流程的质量和 HTA 指南与报销法的一致性方面。在 AOTMiT 采用的“务实”HTA 模式下,制药公司负责按照 HTA 指南准备高质量的报销文件,而 AOTMiT 的评估团队负责对该文件进行严格审查。其他资源有限的国家可以考虑采用这种模式,以平衡不同的优先事项,并确保有需要的患者能够透明、客观地获得药品。