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药品医保综合价值评估框架域外经验及对我国的启示
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| 篇名： | 药品医保综合价值评估框架域外经验及对我国的启示 |
| TITLE： | Drug comprehensive value assessment frameworks for medical insurance：overseas experiences and implications for China |
| 摘要： | 目的 系统比较11个典型国家/地区药品综合价值评价的成熟经验，为我国构建科学规范的医保药品综合价值评价体系提供决策参考。方法采用文献分析法，系统梳理英国、加拿大、意大利、澳大利亚、德国、法国、韩国、日本、美国，以及中国台湾、中国香港共11个典型国家/地区的药品综合价值评价框架，从评价主体、价值维度、结果应用3个层面进行比较。结果与结论多数国家/地区的药品价值评价体系设立有独立的技术评价机构，并纳入多方利益相关者参与（英国、加拿大等）；主流药品价值评价框架已普遍超越传统的安全性、有效性和经济性等核心维度，呈现出评价维度不断延展和证据要求更加严格两大趋势；评价结果与支付政策衔接紧密，包括为决策提供技术性建议（意大利、法国等）或直接决定报销资格（英国、德国等）。建议我国可建立多方参与、评价与决策职能分离的评价机制；构建融合临床、经济、患者及社会价值的综合评价框架，并注重指标的量化探索及真实世界证据应用；推动价值分级结果与医保支付、准入谈判直接联动，以平衡患者获益、基金可持续与产业创新。 |
| ABSTRACT： | OBJECTIVE To systematically compare mature experiences of comprehensive drug value assessment in typical countries/regions and to provide decision-making references for China to establish a scientific and standardized comprehensive drug value assessment system for medical-insured drugs. METHODS The literature analysis was used to systematically review drug value assessment frameworks in 11 representative countries/regions， namely the UK， Canada， Italy， Australia， Germany， France， South Korea， Japan， the United States， as well as Taiwan （China） and Hong Kong （China）. Comparisons were made across three dimensions： assessment entities， value dimension， and application of results. RESULTS &CONCLUSIONS In most countries/regions， independent technical assessment institutions have been established as part of the drug value evaluation system， with the involvement of multiple stakeholders （e.g.， the UK， Canada）. The mainstream drug value assessment frameworks have generally transcended the traditional core dimensions of safety， efficacy， and cost-effectiveness， exhibiting two major trends： the continuous expansion of assessment dimensions and stricter evidence requirements. Assessment outcomes are closely integrated with payment policies， ranging from providing technical advice for decision-making （e.g.， Italy， France） to directly determining reimbursement eligibility （e.g.， the UK， Germany）. The following recommendations are proposed for China： first， establish an evaluation mechanism featuring multi-stakeholder participation and separation of evaluation from decision-making. Second， develop a comprehensive evaluation framework integrating clinical， economic， patient， and societal value， emphasizing quantitative indicator exploration and real-world evidence application. Third， promote direct linkage between value-based tiering outcomes and medical insurance reimbursement decisions or access negotiations to balance patient benefits， fund sustainability， and industrial innovation. |
| 期刊： | 2026年第37卷第04期 |
| 作者： | 刘翊珺；李丹；张余；江滨 |
| AUTHORS： | LIU Yijun，LI Dan，ZHANG Yu，JIANG Bin |
| 关键字： | 药品综合价值评价；医保决策；药品价值；价值框架 |
| KEYWORDS： | comprehensive drug value assessment； medical insurance decision-making； drug value； value framework |
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