英国癌症药物基金的疗效风险分担协议分析  

Analysis of performance-based risk-sharing agreements of the Cancer Drug Fund in the United Kingdom

作　　者：李伟[1,2] 施慧 丁锦希[1,2] 郑晓玲 LI Wei;SHI Hui;DING Jin-xi;ZHENG Xiao-ling(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China;Pharmaceutical Market Access Policy Research Center,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学国际医药商学院,南京211198 [2]中国药科大学医药市场准入政策研究中心,南京211198

出　　处：《中国新药杂志》2021年第17期1559-1564,共6页Chinese Journal of New Drugs

基　　金：中国药科大学“双一流”学科创新团队建设项目(CPU2018GY4);江苏省教育厅2019年度高校哲学社会科学研究一般项目(2019SJA0063)。

摘　　要：随着我国药品注册审评体系的优化,愈来愈多的"全球新"创新药,尤其是附条件审批上市的创新药在我国加快上市,对于此类在真实世界尚未积累充分证据的药品,如何平衡临床需求与医保基金风险、科学设计医保准入方案,是我国医保部门亟待解决的问题。英国自2011年起成立了专门针对癌症药物进行补偿的英国癌症药物基金(Cancer Drugs Fund,CDF),通过与药品生产企业签订的管理准入协议(managed access agreement,MAA),收集真实世界的疗效数据、定期评估后决定是否将该抗癌药物纳入国民健康服务体系(National Health Service,NHS)的常规报销或退出补偿范围,从而解决其"疗效不确定性"。本文通过对CDF实行的MAA协议的运行模式、药品种类、协议要素进行分析,为我国医保部门在准入高值创新药物的医保管理方面提供一定参考。With the optimization of drug evaluation and approval system in China,an increasing number of"global new"innovative drugs,especially those with conditional approval,are being marketed in China.For such drugs that have not yet accumulated sufficient evidence in real world,urgent problems,such as how to balance clinical needs with the risks of medical insurance funds and scientific designing of medical insurance access plans,are yet to be solved by China medical insurance departments.While in the United Kingdom(UK),the Cancer Drugs Fund(CDF)has been set up since 2011,which specializes in compensation for anticancer drugs.Through the managed access agreements(MAAs)signed with drug manufacturers,CDF regularly collects and evaluates the real-world therapeutic data,and decides whether to include or withdraw this anticancer drug in the reimbursement scope of the National Health Service(NHS),solving the"uncertainty of drug therapeutic effect"potently.This paper analyzes the operation mode,drug types,and agreement elements of the MAAs implemented by the CDF in recent years in order to provide a reference for the medical insurance management of high-value innovative drugs reimbursement accessing in China.

关 键 词：英国癌症药物基金 疗效不确定性 风险分担 运行模式 协议要素 

分 类 号：R956[医药卫生—药学]