The US Centers for Medicare and Medicaid Services (CMS) issued a proposal that would see an increase in payments for CAR-T cell therapies, such as Gilead Sciences' Yescarta (axicabtagene ciloleucel) and Novartis' Kymriah (tisagenlecleucel). CMS administrator Seema Verma said the agency is acting due to concerns that its current CAR-T payment structure could be "inadequate and might be impacting access to care."
The proposal comes after CMS unveiled plans in February to cover autologous treatment with CAR-T cell therapy through coverage with evidence development when performed in a hospital. The move is designed to improve access to the treatment, whilst also enhancing the agency's understanding of how patients in Medicare respond to it.
Under the new proposal, the maximum new technology add-on payment for CAR-T cell therapies would increase from 50 percent of the estimated costs of the case to 65 percent, while the maximum add-on would increase from $186 500 to $242 450. "CAR-T is a great example around how government policy has really thwarted innovation," Verma said, adding "It is clear that technology is moving faster than government policies."
Both Yescarta and Kymriah have list prices of $373 000 for use in patients with advanced diffuse large B cell lymphoma, while Novartis' product costs $475 000 for use in children with acute lymphoblastic leukaemia. However, sales of the products have so far fallen below expectations due to low reimbursement, with revenue from Yescarta reaching $81 million in the fourth-quarter of 2018 and Kymriah posting sales of $45 million in the first quarter of this year. Gilead said it was still reviewing the CMS proposal, but was encouraged by comments regarding payment.
CMS indicated that the proposed changes, which target about 3300 acute care hospitals and 390 long-term care hospitals, would cover discharges occurring on or after October 1, 2019. The agency said it is seeking public consultation on the proposals, with the responses informing future rulemaking after the final rules are implemented in the 2020 fiscal year.
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