The reimbursement difficulties faced in the UK by the CAR-T therapies Kymriah and Yescarta could be illustrative of the hurdles they will have to leap in other EU countries, which will have similar concerns over cost and the lack of comparator studies that have caused the health technology assessment (HTA) body NICE to issue preliminary guidance rejecting their routine use on the National Health Service.
CAR-T Therapies Should Impress EU Reimbursement Bodies
Health authorities in Europe have different approaches to evaluating the cost-effectiveness of new drugs, but in the case of the CAR-T therapies, they are likely to look favorably on factors such as their innovative nature, the small patient populations, and the dearth of effective treatments.

More from Health Technology Assessment
The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.