FDA Commissioner Voices Concerns About CAR T-Cell Therapy Payment

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, expressed concern in October over the price of chimeric antigen receptor (CAR) T-cell therapies. In an interview with STAT News during a session at the Milken Institute’s Future of Health Summit 2018, Dr. Gottlieb warned that the failure to develop CAR T-cell therapy payment structures could slow the development of the revolutionary therapy.

CAR T-cell therapy allows physicians to remove a patient’s T cells, genetically alter the cells, and reintroduce them into the patient’s body. Available CAR T-cell therapies have list prices of $373,000 and $475,000 for a one-time treatment, leaving insurers struggling with how to pay for the treatment.

While government and private insurers continue their efforts to develop payment plans, Dr. Gottlieb highlighted the urgency of the situation. “I’m extremely worried that if we don’t adapt the approach to reimbursement soon, we may foreclose the therapeutic opportunities,” he told STAT News.

Dr. Gottlieb told the Milken Institute that the FDA might have a role in developing payment plans for CAR T-cell therapies. “There [are] things FDA could potentially do in terms of how we label the products,” he said, though he did not provide specifics. The commissioner also said that the agency was open to outcomes-based contracting, in which payment is tied to the patient’s health outcomes, though the agency rejected such a proposal from CAR T-cell therapy manufacturer Novartis earlier this year.

Originally published on ASH Clinical News