CMS Rule Finalized, CAR-T Therapy Covered By Medicare

CAR-T therapy, a cancer treatment that uses a patient’s own genetically-modified immune cells to fight the disease, will now be covered nationwide by Medicare, according to a final decision released by the Centers for Medicare & Medicaid Services (CMS), Trump administration, and US Secretary of Health and Human Services Secretary Alex Azar.

The press release states that the treatment—approved by the FDA to treat patients with certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia—will be covered by Medicare when administered in health care facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS) for FDA-approved indications.

CMS Administrator Seema Verma said during an interview that this decision means, “‘Yes, this is covered.’ We’re paying that not only for CAR-T, but all the related services. The administration of the drug. The collection of the cells. The manipulation of the cells and then putting it back into the patient. And then any of their outpatient or inpatient care as well.” The decision is welcomed by CAR-T therapy manufacturers like Gilead Sciences and Novartis who believe that coverage may encourage providers to utilize treatments like Yescarta and Kymriah, respectively, now that reimbursement will be possible

CMS emphasized the agency’s commitment to monitor responses and outcomes related to the therapy. Because this decision will create a significant change from current practices, the agency “will leverage information obtained from the FDA’s required post-approval safety studies for CAR T-cell therapies to the fullest extent possible.” It will also require “manufacturers of CAR T-cell therapies to conduct post-marketing observational studies involving patients treated with the therapies.”

“Our robust post-market surveillance programs will continue to monitor for potential risks, as we do for all licensed and approved medical products. We will also continue to carefully assess the benefits and risks when considering whether to approve new CAR-T cell products,” said Acting FDA Commissioner Ned Sharpless, MD, in a press release.

“[The National Cancer Institute] looks forward to continuing to support the expansion of this registry to include more cancer patients in the Medicare program,” said Douglas R Lowy, MD, acting director of NCI in a press release. —Edan Stanley