医保真实世界数据研究面临的挑战

Challenges of Real-World Data Research on Medical Insurance

目的:本研究基于英国国家卫生与服务优化研究院(NICE)的真实世界数据(RWD)应用案例,分析药品医保准入中RWD的角色与挑战,为我国政策制定提供借鉴。方法:采用案例研究法,分析NICE体系下药品准入与管理准入计划(MAA)的实施细节。结果:英国医保体系通过NICE实施的MAA,利用RWD评估药品疗效与成本效益,促进了创新药品快速进入国家医疗服务体系(NHS)。结论:我国可借鉴英国经验,完善RWD相关政策与标准,加强国际合作,推动RWD在医保体系的广泛应用与深入发展,为医疗资源的优化配置与患者的医疗保障提供更加坚实的支撑。

Objective:Based on the real-world data(RWD)application case study of the National Institute for Health and Care Excellence(NICE)in the UK,this study analyzes the roles and challenges of RWD in medical insurance access of drugs,which can provide a reference for the policy making in China.Methods:A case study method was used to analyze the implementation details of the Managed Access Agreement(MAA)under the NICE system.Results:The UK healthcare system has facilitated the rapid entry of innovative medicines into the National Health Service(NHS)by utilizing RWD to assess the efficacy and cost-effectiveness of medicines through the MAA implemented by NICE.Conclusion:China can learn from the UK,improve RWD-related policies and standards,strengthen international cooperation,and promote the wide application and in-depth development of RWD in the medical insurance system,so as to provide a more solid support for the optimal allocation of healthcare resources and patients'healthcare security.