真实世界证据支持药品医保准入的国际经验及启示

International Experience and Implications of Real-World Evidence Supporting Drug Medical Insurance Access

目的:本研究旨在探讨真实世界证据(Real-World Evidence,RWE)在相关国家药品医保准入决策中的应用,以期为我国医保药品目录动态调整的实践提供相关证据与经验支持。方法:通过文献综述方法系统梳理总结当前RWE在英国、法国、德国、意大利、澳大利亚、美国、加拿大等相关国家用于支持药品医保准入决策的经验。结果:重点总结RWE在相关国家医保药品准入决策中的应用场景及具体做法,结合我国既往实践经验,提出RWE支持药品医保目录调整的相关建议。结论:RWE在药品医保准入决策中发挥着日益重要的作用,应结合我国国情及实践经验,参考相关国家可借鉴经验,探索中国特色的RWE支持我国医保药品准入决策的科学路径。

Objective:This study investigates the application of real-world evidence(RWE)in decision-making of drug medical insurance access in major countries,in order to provide evidence and support for the dynamic adjustment of the China’s national medical insurance drug catalog.Methods:A comprehensive literature review was conducted to systematically summarize the current experience of RWE in supporting drug access decision-making in major countries,including the United Kingdom,France,Germany,Italy,Australia,the United States,and Canada.Results:This study focuses on summarizing the application scenarios and specific practice of RWE in drug medical insurance access decision-making in major countries.Based on China’s practice,relevant suggestions are proposed for RWE to support the adjustment of national medical insurance drug catalog.Conclusions:RWE plays an increasingly important role in drug medical insurance access decision-making.By considering China’s national conditions and practical experience,and drawing upon the experience of major countries,a scientific pathway for RWE to support drug medical insurance access decision-making with Chinese characteristics should be explored.