美国ICER药品价值评估框架分析及思考  

Analysis and Reflection on the ICER Drug Value Assessment Framework in the United States

作　　者：马玉芳 李雯霞 杨晓晖 丛佳林 张舒 杨天绎 苏鹏丽 张力[1] 党海霞[4] Ma Yufang;Li Wenxia;Yang Xiaohui;Cong Jialin;Zhang Shu;Yang Tianyi;Su Pengli;Zhang Li;Dang Haixia(Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Dongzhimen Hospital,Beijing University of Chinese Medicine;Rutgers University;China Academy of Chinese Medical Science)

机构地区：[1]北京中医药大学东方医院,北京100078 [2]北京中医药大学东直门医院 [3]Rutgers University [4]中国中医科学院

出　　处：《药物流行病学杂志》2021年第7期441-447,共7页Chinese Journal of Pharmacoepidemiology

基　　金：国家食品药品监督管理总局政策研究课题(编号:G201501);国家中医药管理局课题(编号:GZY-FJS-2020-206)。

摘　　要：美国临床经济评价研究所(ICER)长期致力于药品价值评估框架及技术方法体系研究,为美国的药品定价与医保支付等管理决策提供有效支撑。在介绍了ICER价值框架基本构成要素和评估流程的基础上,从比较临床效果、证据来源、评估视角、价格基准、疾病背景及潜在利弊的定性评估及修订ICER框架评估罕见病和新型冠状病毒肺炎等8个方面总结了ICER价值评估体系的特点。同时,结合我国药品价值评估开展的现状,提出除组建独立的价值评估机构外,还应纳入多来源的证据并对证据进行评估,建立符合我国药品架构特点的评估技术体系以及探索引入“价格基准”指导药品定价等3个方面进一步推动我国药品定价与医保支付与补偿运行机制的完善。The Institute for Clinical and Economic Review(ICER)has long been committed to the research of drug value assessment framework and technical method system,providing effective support for drug pricing and medical insurance payment management decisions in the United States.Based on the novel coronavirus of the ICER value assessment framework and its assessment process,the characteristics of the ICER drug value assessment framework are summarized from 8 aspects:comparative clinical effectiveness,evidence sources,assessment perspective,price benchmarks,qualitative evaluation of contextual considerations and other benefits or disadvantages,modifications to the ICER value assessment framework for treatments for ultra-rare diseases and COVID-19.As well as,combined with the current situation of drug value assessment in China,it is proposed that in addition to the establishment of an independent value evaluation agency,multi-source evidence should be included and graded,set up the value assessment framework with the characteristics of China’s drug architecture,and explore the introduction of“price benchmark”to guide drug pricing,so as to further improve the operation mechanism of drug pricing and medical insurance payment and compensation.

关 键 词：美国临床经济评价研究所 药品价值 价值框架 药品定价 医保支付 

分 类 号：R951[医药卫生—药学]