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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 ； |
| 阅读数： | 418 次 |
| 本月下载数： | 11 次 |
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