Article(id=1322180234980470864, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1626105600000, acceptedDateStr=2021-07-13, onlineDate=1793161932940, onlineDateStr=2026-10-28, pubDate=1631635200000, pubDateStr=2021-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793161932940, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793161932940, creator=13701087609, updateTime=1793161932940, updator=13701087609, issue=Issue{id=1322180233244038010, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='17', pageStart='1537', pageEnd='1632', issueExtLink='null', onlineDate='null', pubDate='1631635200000', pubDateStr='2021-09-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793161932525, creator='13701087609', updateTime=1793162118166, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322181011941732619, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322181011945926924, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1559, endPage=1564, ext={EN=ArticleExt(id=1322180235185991761, articleId=1322180234980470864, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of performance-based risk-sharing agreements of the Cancer Drug Fund in the United Kingdom, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

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.

, authors=Wei LI^{1, 2}, Hui SHI¹, Jin-xi DING^{1, 2}, Xiao-ling ZHENG¹, authorsList=Wei LI, Hui SHI, Jin-xi DING, Xiao-ling ZHENG, authorCompany=null, correspAuthors=Jin-xi DING, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322180235496370258, articleId=1322180234980470864, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=英国癌症药物基金的疗效风险分担协议分析, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

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。

, authors=李伟^{1, 2}, 施慧¹, 丁锦希^{1, 2}, 郑晓玲¹, authorsList=李伟, 施慧, 丁锦希, 郑晓玲, authorCompany=null, correspAuthors=丁锦希, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=1JKoNolCigqDkISxpVOgig==, magXml=u8WZQ91wjJcTmR8mRYkPVw==, pdfUrl=null, pdf=8iqzs+LNl9OQYix5amkmwA==, pdfFileSize=1452371, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=AKRUeTPNt34hDLXWycuybQ==, mapNumber=null, fund=null)}, authors=[Author(id=1322180235899023450, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180234980470864, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=cpuliwei@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1322180235987103837, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322180234980470864, authorId=1322180235899023450, language=EN, stringName=Wei LI, firstName=Wei, middleName=null, lastName=LI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^{1, 2}, address=¹School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
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李伟，男，讲师，博士研究生在读，主要从事医药市场准入与医疗保障政策研究。E-mail：cpuliwei@163.com。

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李伟，男，讲师，博士研究生在读，主要从事医药市场准入与医疗保障政策研究。E-mail：cpuliwei@163.com。

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