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·药事管理·


          药品医保综合价值评估框架域外经验及对我国的启示
                                                                                            Δ

                 1*
                          1
                                           1, 2 #
          刘翊珺 ,李 丹 ,张 余 ,江 滨 (1.北京大学药学院,北京 100191;2.北京大学公共政策研究中心,
                                   1
          北京 100871)
          中图分类号  R95      文献标志码  A      文章编号  1001-0408(2026)04-0413-07
          DOI  10.6039/j.issn.1001-0408.2026.04.01

          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。
          关键词  药品综合价值评价;医保决策;药品价值;价值框架

          Drug comprehensive value assessment frameworks for medical insurance:overseas experiences and implications
          for China
          LIU Yijun ,LI Dan ,ZHANG Yu ,JIANG Bin (1.  School  of  Pharmaceutical  Sciences,  Peking  University,
                                        1
                                                    1, 2
                   1
                           1
          Beijing 100191, China;2. Center for Public Policy Research, Peking University, Beijing 100871, China)
          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.
          KEYWORDS    comprehensive drug value assessment; medical insurance decision-making; drug value; value framework


              药品价值是临床合理用药与医保战略性购买的核                          基础上,已逐步引入药物经济学,构建起“成本-效益”分
          心依据。传统的药品价值评价在关注安全性、有效性的                           析框架 。为推动药品回归临床价值,《国家卫生健康委
                                                                   [1]
                                                             关于开展药品使用监测和临床综合评价工作的通知》等
             Δ 基金项目 国家自然科学基金项目(No.72274008)
             *第一作者 博士研究生。研究方向:医药政策决策与效果评价。                   一系列政策文件相继出台,构建了涵盖安全性、有效性、
          E-mail:liuyijunh@163.com                           经济性、创新性、适宜性与可及性的药品临床综合评价
             # 通信作者 研究员,博士生导师。研究方向:医药政策决策与效                  框架  [2―3] ,并由国家层面主导,推动该项工作在儿童用
                                                                                         [4]
          果评价、药物经济学。E-mail:binjiang@bjmu.edu.cn              药、肿瘤用药等领域的具体实践 。该框架主要从临床

          中国药房  2026年第37卷第4期                                                 China Pharmacy  2026 Vol. 37  No. 4    · 413 ·
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