Medicare has finalized its long overdue national coverage decision on CAR-T therapy, an innovative but expensive new cancer treatment that uses patients' immune cells to fight against the disease.
Under the policy, Medicare will pay for CAR-T therapy providing "consistent and predictable patient access nationwide," CMS Administrator Seema Verma said.
The agency will cover CAR-T therapy when it is administered in healthcare facilities enrolled in the Risk Evaluation and Mitigation Strategies program, mandated by the FDA for safety.
Medicare will also pay for the therapy even when it is used to treat conditions that aren't FDA approved if it is "recommended by CMS-approved compendia."
The policy is different from the agency proposal released in February, which would have required hospitals to collect and report data on patient outcomes over a long period of time. The final decision dropped that requirement and instead will rely on patient information collected by the FDA and National Cancer Institute, according to the coverage decision. The FDA is requiring the two manufacturers that market CAR-T therapies, Gilead and Novartis, to follow patients and report on outcomes
Ms. Verma said the coverage decision was initially scheduled for late May, but the agency struggled to figure out how to cover and pay for the treatment, which costs $375,000 to $475,000, according to The Washington Post.
The agency announced last week it would boost what Medicare would reimburse for CAR-T from 50 percent to 65 percent.
Currently, the two CAR-T treatments on the U.S. market are Gilead's Yescarta and Novartis' Kymriah. Yescarta is approved to treat non-Hodgkin lymphoma, and Kymriah is approved to treat acute lymphoblastic leukemia.