CMS Delays National Coverage Determination for CAR T-Cell Therapy

The Centers for Medicare and Medicaid Services (CMS) announced today that it will not yet issue a national coverage determination on chimeric antigen receptor (CAR) T-cell therapy for cancer. But a spokesperson said a decision is forthcoming.

The agency started analyzing national coverage for CAR T-cell therapies for cancers in May 2018. Individuals had 30 days to comment, with CMS interested in learning about clinical studies and relevant scientific information under review.

“The new immunotherapy treatment CAR-T represents a paradigm change in cancer therapy,” wrote Mounzer Agha, M.D., from the University of Pittsburgh Medical Center’s Hillman Cancer Center. “For the first time, cancer treatment can be directed specifically to the cancer cells, sparing most of the normal cells and resulting in very high remission rates in patients who have otherwise failed all other available treatment.”

CMS issued a proposed decision memo this past February, which stated that the agency would cover autologous treatment with CAR T-cell therapy through coverage with evidence development when prescribed by the treating oncologist and performed in a hospital.

To be treated with CAR T-cell therapy, the patient needs to have relapsed or refractory cancer and not be experiencing comorbidity that would preclude patient benefit.

For hospitals to administer the treatment, they would need a cellular therapy program, a designated care area to protect the patient from transmission of infectious agents and written guidelines when administering the therapy for patient communication, monitoring and transfer to an intensive care unit.

The proposal also noted that CMS coverage requires the treatment to be a U.S. Food and Drug Administration (FDA)-approved biological.

After the approval of an early CAR T-cell therapy in 2017 former FDA Commissioner Scott Gottlieb, M.D., said that gene therapy is a practical solution to deadly and largely untreatable forms of cancer. He said the FDA is committed to supporting and helping expedite the development of cell-based regenerative medicine.

The FDA finalized two guidance documents regarding such therapies in February 2019. The guidance Evaluation of Devices Used with Regenerative Medicine Advanced Therapies explains how the FDA will evaluate devices used in recovery, isolation or delivery of regenerative medicine advanced therapies. The other guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, details the expedited programs that could be available to sponsors of regenerative medicine therapies for serious conditions.

“We know that cell-based therapies and gene therapies may hold transformative promise for patients,” Gottlieb said after the FDA published the documents. “This is why the FDA is so committed to encouraging and supporting safe and effective innovation in this field.”

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