Full refund for CAR-T if the patient has not responded at three months

Italy's AIFA negotiated payment-by-result for tisagenlecleucel with instalments tied to response, and the US CMS Cell and Gene Therapy Access Model (launched 2025 for sickle cell disease) ties Medicaid payment to outcomes negotiated centrally. The proposal is to make a response-conditional refund the default reimbursement structure for oncology CAR-T and other one-time cell therapies in public systems: full price paid at infusion, automatic full or majority refund if no complete or partial response is documented at 90 days in the treatment registry, with the registry rather than the manufacturer adjudicating.