New US proposal calls for Medicare to cover CAR-T cell therapies

The US Centers for Medicare & Medicaid Services (CMS) on Friday proposed to cover autologous treatment with T-cells expressing at least one chimaeric antigen receptor (CAR) through so-called coverage with evidence development when performed in a hospital. The move "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," stated CMS administrator Seema Varma. 

The proposal, intended for patients with relapsed or refractory cancer who are not experiencing comorbidity that would otherwise preclude benefit, calls for Medicare to cover the CAR-T cell therapy when it is offered in a CMS-approved registry or clinical study, as long as data are collected from patients for at least two years after treatment. The agency indicated that it plans to use the information to determine what treatments are most beneficial to patients and which CAR-T therapies to fund in the future. New hospital payment terms from Medicare are expected later this year.

The only two CAR-T therapies currently approved in the US are Novartis' Kymriah (tisagenlecleucel) and Gilead Sciences' Yescarta (axicabtagene ciloleucel). Kymriah is priced at $475 000 for patients with B-cell precursor acute lymphoblastic leukaemia, although the cost is only recovered if patients respond within 30 days of treatment, while the therapy is priced at $373 000 when prescribed for diffuse large B-cell lymphoma. Yescarta, which is indicated for certain patients with large B-cell lymphoma, carries a US list price of $373 000. 

Commenting on the news, Novartis stated that it is pleased to work with stakeholders to ensure patients have access to CAR-T therapies such as Kymriah and it plans to provide feedback on the CMS proposal during the 30-day open comment period. 

Currently, there is no national Medicare policy for covering CAR-T therapies, so it is up to local Medicare administrative contractors to decide whether to pay for it. Last year, Medicare said it would pay close to its standard mark-up rate for CAR-T therapies administered on an outpatient basis, although patients are nearly always admitted to hospital for treatment given the risk of serious side effects. For hospital patients, Yescarta has been reimbursed under an existing Medicare coverage code and a "new technology add-on payment," but that can leave a large portion of the drug and hospitalisation costs uncovered. 

"We still do not have a clear pathway for Medicare payment," remarked Jack Kolosky, chief financial officer at Moffitt Cancer Center. He noted that Moffitt currently has around $10 million in unpaid Medicare CAR-T claims. 

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