The Centers for Medicare & Medicaid Services (CMS) has indicated it will allow Medicare to pay for CAR-T cell therapies.

Chimeric antigen receptor (CAR) T cell therapies are personalized medicines that provide highly targeted treatment of diseases, with most currently under development for various cancers. These next-generation therapies have great promise to treat diseases with no successful treatment options. They are, however, very expensive.

Patients on Medicare should have hope, however. The Centers for Medicare & Medicaid Services (CMS) has indicated that it will allow Medicare to pay for CAR-T cell therapies.

If this move is made, Medicare would be required to cover CAR-T cell treatments across the country when they are offered in a registry or clinical study approved by the agency. According to CMS Administrator Seema Verma, covering CAR-T cell therapies will allow CMS to gain deeper insight into how well they work for Medicare beneficiaries. 

To that end, hospitals and clinicians looking to offer the treatments must join a registry that tracks outcomes data for comparison with clinical trials. Clinical studies must follow similar guidelines, including tracking data for two years after the treatment.

There may be unexpected hurdles to implementing widespread coverage for personalized medicines, such as CAR-T cell therapies. In addition, previous attempts at coverage with evidence development (CED) have not been successful at generating the data needed by CMS to make decisions about coverage.

Comments are being sought on the plans for CED of CAR-T cell therapies over the next 30 days. A final decision will be issued soon after that.