Inspiration from International Experience on Risk Sharing Agreements of Medical Insurance Access for CAR-T Products
- VernacularTitle:CAR-T产品医保准入风险分担协议的国际经验及启示
- Author:
Wei LI
1
,
2
;
Huli QIN
1
;
Jinxi DING
1
,
2
;
Jiaming LI
1
;
Qirui XIA
1
Author Information
1. School of International Pharmaceutical Business，China Pharmaceutical University，Nanjing 211198，China
2. Center for Pharmaceutical Market Access Policy Research，China P harmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
Chimeric antigen receptor T lymphocyte products;
Medical insurance access;
Risk sharing agreements
- From:
China Pharmacy
2021;32(24):2957-2962
- CountryChina
- Language:Chinese
-
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.
