CMS: Decision on CAR-T Therapy Coverage Delayed But 'Forthcoming'

The therapies have price tags as high as $425,000, which some say is a worthwhile investment.

In a brief statement Friday, the Centers for Medicare & Medicaid Services announced a delay in its final national coverage determination on certain innovative and expensive cancer treatments, but CMS signaled that "a decision is forthcoming."

The agency issued had a proposed decision memo for Chimeric Antigen Receptor (CAR) T-cell therapy for cancers last February, outlining a plan for how it would pay for such treatments, which genetically modify a patient's own cells to fight cancer throughout the body.

Some stakeholder organizations, including America's Health Insurance Plans (AHIP), said a national coverage determination may be beneficial but told CMS to proceed with caution. Others said making such a national determination would be premature for a burgeoning area of medicine.

A year ago, the Food & Drug Administration approved a second CAR-T therapy: Novartis AG's Kymriah. This came after the FDA approved Gilead Sciences Inc.'s Yescarta in 2017. Kymriah and Yescarta each have U.S. prices of $373,000 for patients with advanced lymphoma, and Kymriah has a price tag of $425,000 for pediatric leukemia patients, as Reuters reported last month.

"While the cost of the treatment is quite significant now, it is likely to decline as better manufacturing and increased competition between commercial providers," said Mounzer E. Agha, MD, director of the Mario Lemieux Center for Blood Cancers at UPMC Hillman Cancer Center, in a comment recommending that CMS approve CAR-T coverage.

"Furthermore, the cost of the successful CAR-T therapy is significantly lower than multiple lines of therapy, that are unlikely to yield a meaningful response, but are offered for the lack of effective therapy," Agha added.