- The Centers for Medicare and Medicaid Services revealed Wednesday that they are initiating a National Coverage Analysis for CAR-T therapies in order to determine whether the pricey cancer drugs deserve to be nationally reimbursed by Medicare.
- CMS expects the analysis to be complete by May 17, 2019, and will host a public comment period for the next month. "CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review," said the agency website.
- The agency previously disclosed that it had agreed to reimburse hospitals through the Medicare Part B program for the recently approved CAR-T therapies, Gilead Sciences' Yescarta and Novartis' Kymriah.
The Food and Drug Administration approved the first chimeric antigen receptor (CAR)-T cell therapies in mid-2017, a first for the groundbreaking, one-time cell therapies. The living drugs are meant to be an infusion given just once, with effects expected to last for years.
Paying for one-time therapies has long been a concern of the healthcare system; industry and payers have proposed different models to handle the new paradigm, including indication-based payments, as well as payment plans over time. Yet, those new payment models are still taking shape, and both CAR-T therapies carry large price-tags. The original wholesale acquisition cost was $475,000 for Kymriah (tisagenlecleucel) and $373,000 for Yescarta (axicabtagene ciloleucel).
The National Coverage Analysis is the first step in developing a uniform national coverage policy for Medicare. CMS will host a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting on Aug. 22 to discuss information related to the therapies. A proposed decision is expected by Feb. 16, 2019.
The CMS analysis comes after UnitedHealthcare sent a letter to the agency requesting a national coverage determination "to clarify the circumstances under which the therapies will be covered and to create consistent patient access to the therapies across the country and financial sustainability in the Medicare Advantage program with regard to these therapies."
Currently, only a few patients have been treated with the pricey therapies. Both drugs were approved for small patients populations. Yescarta is indicated for adults with relapsed or refractory large B-cell lymphoma who already received two or more lines of systemic treatment. Kymriah was originally approved for patients 25 and younger with refractory B-cell precursors acute lymphoblastic leukemia that has relapsed at least twice, and later gained a second indication in relapsed or refractory diffuse large B cell lymphoma.
Kymriah brought in only $12 million during the first quarter, while Yescarta had sales of $40 million, beating consensus estimates.
Not only will a national coverage decision help insurers provide more consistent coverage across state lines, but it could also help increase sales of the drugs.
"[T]his could improve visibility on reimbursement and drive more utilization of CAR-T for 2019-20 if CMS is regularly covering CAR-T for reimbursement. We think recent GILD Yescarta Q1 sales, feedback from docs and centers in the US, and growing awareness and pot'l reimbursement - support a growing market and adoption for CAR-T therapy over next few years," wrote Jefferies analyst Michael Yee in a note to clients.