CMS plans to cover a specific kind of immunotherapy for cancer patients, it announced Friday.
The Centers for Medicare & Medicaid Services revealed that it intends to allow Medicare to pay for chimeric antigen receptor (CAR) T-cell therapy, in which oncologists use a patient’s own immune system to attack a tumor.
The determination would require that Medicare cover CAR T-cell treatments across the country when it is offered in a registry or clinical study approved by the agency. CMS Administrator Seema Verma said in a statement that covering such therapies will allow CMS to gain deeper insight on how well it works for Medicare beneficiaries.
“Today’s proposed coverage decision would improve access to this therapy while deepening CMS’ understanding of how patients in Medicare respond to it, so the agency can ensure it is paying for CAR T-cell therapy for cases where the benefits outweigh the risks,” Verma said.
The plan includes several data requirements. 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.
In CAR T-cell therapy, a patient’s white blood cells are extracted and modified with a receptor that drives the cells to seek out the cancer and attack it. The ultimate goal of the therapy is to not only kill existing tumors but provide an internal line of defense against future cancers.
“CAR T-cell therapy was the first FDA-approved gene therapy, marking the beginning of an entirely new approach to treating serious and even life-threatening diseases.” Learn more here: https://t.co/VxuEFCvcC9 pic.twitter.com/KYhTNNjr3f— Administrator Seema Verma (@SeemaCMS) February 15, 2019
Sean Parker, a Silicon Valley veteran and billionaire philanthropist who is at the forefront of research on these therapies, likened the modified cells to “nanobots” inside the body.
CMS is seeking comment on the plans for coverage with evidence development (CED), which it is accepting over the next 30 days. Should it decide to finalize the coverage plan, it will issue a final decision shortly thereafter.
Experts in precision medicine warn that there may be significant hurdles to expanding coverage to these therapies. Cynthia A. Bens, senior vice president for public policy at the Personalized Medicine Coalition, said in a statement to FierceHealthcare that CED determinations have proved “challenging to implement” in the past.
This coverage decision, she said, also marks the first time that CMS is taking such an approach for a cancer treatment. It rarely does so with drugs or biologics, she said.
She also warned that previous CEDs have failed to generate the evidence CMS needs to make appropriate coverage decisions.
“It is our hope that if CMS moves forward with a CED requirement, the agency will incorporate feedback received from our members, who represent innovators, patients, providers and payers, to ensure that Medicare beneficiaries facing poor prognoses and their healthcare providers will not suffer from delays in coverage of CAR-T therapies,” Bens said.