cancer therapy
The Centers for Medicare & Medicaid Services (CMS) is calling on the US Food and Drug Administration to include a breakthrough cancer therapy CAR T-Cell under Medicare. Pictured: Dr. Benjamin Jin, a biologist working on immunotherapy for HPV+ cancers, holds test tubes Getty Images/Saul Loeb/AFP

The Centers for Medicare & Medicaid Services (CMS) is calling on the US Food and Drug Administration to include a breakthrough cancer therapy CAR T-Cell under Medicare. There is currently no federal coverage of this treatment and availing so would cost the patient between $370,000 and $500,000.

CAR T-cell therapy is an FDA-approved gene treatment that uses a patient’s own immune system to combat the disease. The T-cells are genetically-engineered and designed to target malignant cancer cells. At present, only two pharmaceutical companies provide this therapy: Gilead Science’s Yescarta and Novartis’ Kymriah.

In a press release, CMS proposed that the National Coverage Determination require Medicare to cover the treatment provided that it is offered in either a clinical study where patients are monitored for at least two years after being treated or a CMS-sanctioned registry. It added that the results from these channels will help the institution discover the different advantages of CAR T-cell therapy and which patients can benefit from it, so that Medicare can determine levels of coverage. The CMS is also seeking public opinion on the move through its website.

The proposal, titled “Coverage with Evidence Development,” was presented in response to a request made by UnitedHealthcare chief medical officer for Medicare and retirement Dr. Efrem Castillo, who asked that the procedure be considered for Medicare coverage to level the playing field among Medicare Advantage plan providers, as well as give patients wider options for treatment.

The CMS will issue a final decision on its proposal up to 60 days after its public comment period, which began Feb. 15.