While they offer significant promise for patients with aggressive non-Hodgkin’s lymphoma, CAR-T therapies also carry enormous costs – not only from their list prices, but also from supportive care – that create significant financial risks for private and government payers. In response, a researcher from New York’s Memorial Sloan Kettering Cancer Center offered a few ideas for how the Centers for Medicare and Medicaid Services can pay for them.
CMS will meet next Wednesday to discuss a National Coverage Analysis for CAR-Ts that it is performing at the request of UnitedHealthcare. The health insurer requested the NCA in a Feb. 22 letter due to concerns about how to provide for consistent patient access nationwide and financial sustainability in the Medicare Advantage program, in which UnitedHealthcare is a provider. A memo from the NCA is due next February, and the project is expected to complete three months later.
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In an article published Wednesday in the New England Journal of Medicine, Dr. Peter Bach, director of MSKCC’s Center for Health Policy and Outcomes, suggested several potential policies to ensure coverage, depending on how confident CMS is in the similarity between the CAR-T therapies in terms of their benefit to patients and their ancillary costs. In particular, these could include competition on price or even randomized, controlled clinical trials.
The FDA approved Kite Pharma’s – now Gilead Sciences’ – Yescarta (axicabtagene ciloleucel) for diffuse large B-cell lymphoma, an NHL subtype, last year. Novartis’ Kymriah (tisagenlecleucel) won approval for DLBCL this year, after its landmark approval last year for pediatric acute lymphoblastic leukemia. Another CAR-T, lisocabtagene maraleucel, developed by Juno Therapeutics – now part of Celgene – is also in development.
Those ancillary costs are a big part of the problem when it comes to paying for CAR-Ts. When it launched Yescarta, Kite’s list price for the product was a hefty $373,000, a price that Novartis matched for Kymriah in DLBCL, after setting its pediatric ALL price point at $475,000. Ancillary costs – for services like leukapheresis, hospitalization and treatment for the often serious side effects associated with CAR-T – could range from the $33,000 calculated in a study earlier this year to hundreds of thousands of dollars.
At the moment, most commercial insurers are covering CAR-T therapies, but doing so on a patient-by-patient basis. Meanwhile, for pediatric ALL, CMS quietly pulled out of a much-heralded pay-for-performance deal whereby Medicaid would cover Kymriah’s price as long as patients responded within 30 days of administration, after scrutiny from the Department of Health and Human Services raised concerns about potentially improper influence from Novartis.
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In his article, Bach wrote that CMS will have to determine how confident it is in the similarity between the various CAR-Ts’ ancillary service costs and net medical benefits in deciding on an array of potential options for covering them. Depending on the agency’s confidence on those two questions, these could include competitive bidding, bundled payment, competitive acquisition, case-rate payment, a consolidated payment code and other options.
If the agency is not sufficiently confident that the CAR-Ts yield similar benefits to patients, it could limit coverage to those partaking in a randomized, controlled trial. With about 7,500 lymphoma patients expected to qualify for CAR-T per year, most of them eligible for Medicare, a trial of 3,450 patients would provide enough statistical power to confirm similar benefit, assuming a 50 percent response rate, he wrote.
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