Inspiration from International Experience on Risk Sharing Agreements of Medical Insurance Access for CAR-T Products
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Inspiration from International Experience on Risk Sharing Agreements of Medical Insurance Access for CAR-T Products
China PharmacyVol. 32, Issue 24, (2021)
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Published:2021,
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LI Wei, QIN Huli, DING Jinxi, et al. Inspiration from International Experience on Risk Sharing Agreements of Medical Insurance Access for CAR-T Products. [J]. China Pharmacy 32(24).(2021)
DOI:
LI Wei, QIN Huli, DING Jinxi, et al. Inspiration from International Experience on Risk Sharing Agreements of Medical Insurance Access for CAR-T Products. [J]. China Pharmacy 32(24).(2021)DOI:
Inspiration from International Experience on Risk Sharing Agreements of Medical Insurance Access for CAR-T Products
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.