CMS proposes coverage with evidence development for CAR-T

CMS is seeking comments on a proposed coverage with evidence development (CED) for chimeric antigen receptor T-cell (CAR-T) therapy for relapsed or refractory cancer when prescribed by the treating oncologist.

To participate in the CED, the patient must have relapsed or refractory cancer and is not currently experiencing any comorbidity. Participating hospitals must have the following:

• A cellular therapy program that meets the criteria described in the proposal
• A designated care area that protects the patient from transmission of infectious agents and allows for appropriate patient isolation as necessary for treatment and evaluation
• Written guidelines when administering CAR-T for patient communication, monitoring, and transfer to an intensive care unit

The proposed CED appears to follow CMS’ usual guidelines for chemotherapy using FDA-approved indication in addition to the National Comprehensive Cancer Network® compendium indications, says Ronald Hirsch, MD, FACP, CHCQM, vice president of R1RCM Inc., in Chicago. The proposed CED should help CMS better define a future National Coverage Determination and address concerns raised by some stakeholders, he adds.

“UnitedHealthcare, who asked for this NCD, is rightly concerned about indication creep, where a drug approved for one indication is used for other indications where the data on efficacy and safety is less robust,” he says. “Of course, what the NCD does not address is the cost of this treatment, and as Jugna Shah and John Settlemeyer discussed at the Revenue Integrity Symposium in 2018, that is a real issue with CAR-T.”

Comments on the proposed CED are due March 17 and can be submitted electronically here.