Medicare may soon offer coverage of chimeric antigen receptor (CAR) T-cell therapy for patients with cancer, but with considerable restrictions that aim to rein in the treatment’s high cost.
In 2017, the U.S. Food and Drug Administration approved two CAR T-cell products to treat blood cancers; tisagenlecleucel for B-cell acute lymphocytic leukemia and axicabtagene ciloleucel for diffuse large B-cell lymphoma. Both personalized therapies have proven effective for patients whose disease has exhausted other treatment options, but the cost of treatment can exceed $750,000, including doctors’ services and hospital stays.
The Trump administration has proposed that the procedure only be covered by Medicare when it is prescribed by a hematologist/oncologist to treat relapsed or refractory disease, and administered in-hospital, rather than in an outpatient setting (as is becoming increasingly common).
Roy L. Silverstein, MD, 2019 president of the American Society of Hematology (ASH), called it “shortsighted to limit coverage to those patients who have not responded to chemotherapy or have relapsed after chemotherapy.” He predicted that “there will be indications not too far in the future for using these treatments as part of the initial therapeutic plan for patients with certain kinds of cancers.”
The proposed restrictions also require hospitals to monitor patients and enroll them in a study or research registry, from which physicians will report data for at least two years post-treatment.
The request for a coverage decision, which is expected to be made in the next few weeks, came from UnitedHealth Group, the nation’s largest provider of Medicare Advantage Plans.
Source: The New York Times, April 13, 2019.