CAR-T产品医保准入风险分担协议的国际经验及启示
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篇名: CAR-T产品医保准入风险分担协议的国际经验及启示
TITLE: Inspiration from International Experience on Risk Sharing Agreements of Medical Insurance Access for CAR-T Products
摘要: 目的:借鉴国外已上市嵌合抗原受体T淋巴细胞(CAR-T)产品在医保准入中签订风险分担协议的经验,为我国医保部门的相关决策提供参考。方法:以目前已上市的CAR-T产品在英国、法国、意大利、德国等4个样本国家的9份风险分担协议为样本,从协议类型、监测指标、数据收集方式、协议周期、支付条件和支付方式等6个维度剖析CAR-T产品医保支付的国际经验,并为该类产品在我国的医保准入提出建议。结果与结论:4个样本国家普遍与医药企业签订了医保准入风险分担协议(包括经济导向协议和疗效导向协议),通过使用数据收集系统或临床研究数据来收集患者个体的疾病进展、无进展生存期等指标数据,从而监测CAR-T产品的疗效与安全性;根据不同协议类型,确定协议周期与支付条件,通过使用“医保先行支付”和“医药企业垫付”2种方式并结合“分期付款”来进行风险控制。解决“疗效不确定性”所带来的医保基金风险是CAR-T产品准入的核心问题,引入风险分担协议可能是解决这一问题的途径,而科学设计风险分担协议的各要素则是确保协议可操作的前提条件。
ABSTRACT: OBJECTIVE:To learn from the experience of foreign listed chimeric antigen receptor T lymphocyte (CAR-T) products in signing risk sharing agreements in medical insurance access ,so as to provide references for relevant decisions of medical insurance departments in China. METHODS :Taking 9 risk sharing agreements of CAR-T products marketed in the United Kingdom,France,Italy and Germany as samples ,the international experience of medical insurance payment of CAR-T products were analyzed from six dimensions ,such as agreement types ,monitoring indicators ,data collection metho ds,agreement periods , payment conditions and payment methods. Some suggestions were put forward for the medical insurance access of these products in China. RESULTS & CONCLUSIONS :Four sample countries generally signed risk sharing agreements of medical insurance access (financial agreement and performance-based agreement )with pharmaceutical enterprises ;the indicators such as progressive disease and progression-free survival were collected by using data collection system or clinical research data ,so as to monitor the efficacy and safety of CAR-T products. The agreement periods and payment conditions were determined according to different agreement types;“medical insurance advance payment ”or“pharmaceutical enterprise advance payment ”combined with “staged payments ” were adopted for risk control. Solving the risk of medical insurance funds caused by “efficacy uncertainty ”is the core issue of CAR-T product access. The induction of risk sharing agreements may be the way to solve this problem ,and the scientific design of the various elements of risk sharing agreements is a prerequisite to ensure that the agreement is operational.
期刊: 2021年第32卷第24期
作者: 李伟,覃胡莉,丁锦希,李佳明,夏启瑞
AUTHORS: LI Wei,QIN Huli,DING Jinxi,LI Jiaming ,XIA Qirui
关键字: 嵌合抗原受体T淋巴细胞产品;医保准入;风险分担协议;国际经验;启示
KEYWORDS: Chimeric antigen receptor T lymphocyte products ; Medical insurance access ; Risk sharing agreements ;
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