The Centers for Medicare & Medicaid Services (CMS) announced that chimeric antigen receptor (CAR) T-cell therapies, a costly option to treat specific cancers, will now be made available to certain cancer patients under Medicare.
“President Trump is committed to strengthening the Medicare program by ensuring that beneficiaries have access to new and potentially lifesaving treatments. As the first type of FDA-approved gene therapy, CAR T-cell therapies are an important scientific advancement in this promising new area of medicine and provide treatment options for some patients who had nowhere else to turn,” said CMS Administrator Seema Verma in a press release. “Today’s coverage decision provides consistent and predictable patient access nationwide. CMS will work closely with our sister agencies to monitor outcomes for Medicare patients receiving this innovative therapy going forward.”
The decision applies to coverage at healthcare facilities enrolled in the U.S. Food and Drug Administration (FDA) risk evaluation and mitigation strategies for FDA-approved indications. Medicare will also cover CAR T-cell therapies previously approved by the FDA for “off-label uses that are recommended by CMS-approved compendia,” per a CMS press release.
CAR T-cell therapy uses a patient’s own cells, which are altered in the lab to specifically attack cancer cells.
Two CAR T-cell therapy treatments are currently on the market and were approved by the FDA: Gilead Sciences’ Yescarta and Novartis’ Kymriah. Yescarta is indicated for patients with non-Hodgkin lymphoma in whom at least two other treatments have failed. Kymriah is designed for acute lymphoblastic leukemia patients aged 25 years and younger.
Both come with significant price tags—according to a Reuters report, a one-time treatment costs at least $373,000.
According to a report from STAT, “CMS’ decision to write these rules, known as a national coverage determination, has been shrouded in controversy. The two drug makers already selling CAR-T treatments have argued the national coverage policy is entirely unnecessary, because the contractors that administer Medicare’s hospital claims were already paying for the treatment. Others, including doctors groups, criticized a number of policies in the draft proposal.”
One of the initial concerns—that the treatment could only be used in a hospital—has been addressed by emphasizing the treatment is to be used at “healthcare facilities.” The latest decision also eliminates an earlier CMS requirement that would have made hospitals responsible for collecting and reporting long-term patient data on the treatments, which are relatively new.