Medicare finalises decision to cover CAR-T cell therapies Yescarta, Kymriah

The US Centers for Medicare and Medicaid Services (CMS) finalised a proposal made earlier this year to cover CAR-T cell therapies, such as Gilead Sciences' Yescarta (axicabtagene ciloleucel) and Novartis' Kymriah (tisagenlecleucel), when provided in healthcare facilities that have programmes in place to track patient outcomes. CMS administrator Seema Verma said the nationwide decision clears up "a lot of confusion" about coverage.

The move comes after the CMS recently finalised a proposal made in April that will see the maximum new technology add-on payment for CAR-T cell therapies increase from 50% of the estimated costs of the case to 65%, while the maximum add-on would increase from $186,500 to $242,450.

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. Meanwhile, Yescarta, which is indicated for certain patients with large B-cell lymphoma, carries a US list price of $373,000.

The agency said it will also cover the therapies for uses not authorised by the FDA, as long as they are recommended by CMS-approved medical guidelines. Verma indicated that hospitals can also apply for an additional outlier payment offered for some new breakthrough therapies, noting that when combined with the maximum new technology add-on payment, some providers are getting close to the average sales price of the drugs.

"This whole issue of CAR-T is really bringing up the issue of how expensive the new therapies that are coming out are," Verma remarked, adding "while they are lifesaving and they are transformative, and we haven't seen this type of development before in terms of a curative treatment, I do think it's sort of begging the question how is the system going to pay for this over the long term."

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