Posted by Michael Wonder on 25 Oct 2018
FDA's Gottlieb 'extremely worried' on CAR-T reimbursement
24 October 2018 - FDA Commissioner Scott Gottlieb stressed the need for reform on the reimbursement side of medicine, calling it an "ossified paradigm" that could weigh on cutting-edge therapies like CAR-T cancer therapy.
Once again, Gottlieb waded into topics that his agency doesn't directly work on. Generally, reimbursement in government-sponsored health insurance falls to the Centers for Medicare and Medicaid Services, while private insurers make their own decisions on covering the medical costs.
Gottlieb contrasted a "highly nimble, highly innovative" model for developing drugs that target rare diseases to an "ossified" reimbursement system. He lamented how radioactive pharmaceuticals had "some good drugs at the time that worked" but are no longer used due to reimbursement issues, directly comparing that experience to what CAR-T may face.
