CMS Wrestles With Coverage Issues for CAR-T Therapies

UnitedHealth Group and AHIP request a ruling about Medicare Advantage payment obligations for expensive immunotherapies.

The manufacturing process is complicated and painstaking, just one of the reasons for the costs. And you know about them, by now; how Novartis’s immunotherapy, Kymriah, lists for between $373,000 or $475,000, depending on the type cancer being battled, and Gilead Sciences’s immunotherapy, Yescarta, lists for $373,000. The manufacturing process for CAR-T involves taking T cells from a patient, and then genetically altering them in a lab so that they can recognize and fight cancer cells.

UnitedHealth Group, the largest player in the Medicare Advantage market with about five million members and 25% of the market, wants the Trump administration to rule on just what an insurer’s obligations are for Medicare beneficiaries regarding CAR-T coverage, the New York Times reported over the weekend.

AHIP warns that there’s not enough clinical evidence to mandate coverage. But CAR-T has been proven to be remarkably effective in many patients whose cancer has not responded to traditional chemotherapy or radiation, one of the reasons the FDA approved it for certain blood cancers.

“The Trump administration has proposed covering CAR-T therapy when it is prescribed by a cancer specialist and given in a hospital to Medicare patients whose cancer has not responded to other treatments like chemotherapy and radiation,” the Times reports. “Medicare would also cover the treatment for patients whose cancer returns, causing a relapse after a period of improvement.”

Caron A. Jacobson, MD, director of a cell therapy program at the Dana-Farber Cancer Institute in Boston, argues that the price tag may not be as daunting as it looks when taken in context; “when you actually consider what you are paying for over the course of someone’s lifetime, and you think about the cost of other therapies that this is replacing, it actually is not astronomical.”