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Medicare will cover CAR-T therapies in United States

pharmafile | August 8, 2019 | News story | Sales and Marketing CAR-T therapies, Cancer, Gilead, Kymriah, Medicare, Novartis, keytruda, pharma 

Medicare will cover the cost of Novartis’ and Gilead’s CAR-T therapies Kymriah and Yescarta, the US Centers for Medicare and Medicaid services (CMS) said.

Medicare, the federal government’s health plan for over-65s has said it will cover the FDA approved CAR-T therapies Kymriah and Yescarta when provided in healthcare facilities that have programmes in place to track patient outcomes, known as REMS.

Medicare will also pay for the immunotherapies in conditions in which the drugs are not FDA approved as long as they are recommended by CMS approved medical guidelines.

The clarification will likely increase uptake of the drugs which costs hundreds of thousands of dollars each. Kymriah and Yescarta are currently approved in the US for certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.

CMS Administrator Seema Verma, commented: “Today’s coverage decision provides consistent and predictable patient access nationwide. CMS will work closely with our sister agencies to monitor outcomes for Medicare patients receiving this innovative therapy going forward.”

Acting FDA commissioner Dr Ned Sharpless said: “We remain committed to supporting the efficient development of safe and effective CAR T-cell therapies. We know there are relatively limited data about the use of these life-saving therapies in the Medicare population. Our robust postmarket surveillance programs will continue to monitor for potential risks, as we do for all licensed and approved medical products. We will also continue to carefully assess the benefits and risks when considering whether to approve new CAR T-cell products.”

Louis Goss

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