New proposals from the Centers for Medicare and Medicaid Services (CMS) could result in Medicare covering the latest CAR T-cell therapy as a viable treatment for cancer. 

Under the terms released, Medicare patients with relapsed or refractory cancers could get coverage for CAR T-cell therapy if their particular clinic conforms to specific provisions such as two years of patient monitoring after the treatment. The information gathered could then later be used to decide which CAR-Ts are the most beneficial and effective for future funding.

As of today, only two CAR-Ts have reached the U.S. market with dozens more in clinical pipelines. Most are being targeted for difficult-to-treat cancers which also qualify for accelerated review processes and therefore a shorter path to approval.

Seema Verma, CMS administrator said: “CAR T-cell therapy was the first FDA-approve gene therapy, marking the beginning of an entirely new approach to treating serious and life-threatening diseases.

“Today’s proposed coverage decision would improve access to this therapy while deepening CMS’s understanding of how patients in Medicare respond to it, so the agency can ensure that it is paying for CAR T-cell therapy for cases in which the benefits outweigh the risks.”

The two specific CAR-T treatments that have reached the market and are FDA approved are Novartis’ Kymriah and Gilead Sciences’ Yescarta – priced at $475,000 and $373,000 respectively.

CAR-T cell therapy works by taking a patients own T cells, re-engineering them to fight cancer cells and then reinfusing them into the patient.

See “The Mechanics of CAR T-cells in oncology” for a more detailed explanation.