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。
Abstract
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.
关键词
真实世界证据 /
医保决策 /
药品报销准入 /
国际经验
Key words
real-world evidence /
medical insurance decision-making /
drug access /
international experience
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基金
国家自然科学基金项目“数智化驱动的罕见病多重保障机制设计与实证研究”（72342015）
