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CAR T-cell therapy receives national Medicare coverage



Medicare will cover an innovative, yet affordable cancer treatment nationwide, a step Trump authorities said Wednesday would ensure patients "consistent and predictable access" to a possible life-saving therapy.

In the announcement of the decision, Seema Verma, administrator of the Centers for Medicare and Medicaid Services, said that until now Medicare's regional administrators had decided whether to cover the treatment, which led to confusion.

Verma said the agency, which had originally planned this coverage decision in late May, has struggled to figure out how to cover and pay for the treatment, called CAR T-cell therapy. The treatment costs $ 375,000 or $ 475,000, depending on whether it is used for advanced lymphoma or pediatric leukemia. Hospital stays can add hundreds of thousands of dollars to care costs.

Medication Products Note BIL-T therapy is designed to be administered only once and to be a potential cure for patients who have run out of other alternatives. However, not all patients benefit from it, and because it is so new, it is too early to know if it will deliver long-term cures.

Such expensive treatments are "begging the question of how the system will pay for this over the long term," Verma said, especially given Medicare's significant financial burdens. "This is something we are extremely concerned about," she added.

The coverage decision announced Wednesday is different in some key aspects of a February agency proposal, which proposed "coverage with evidence development" – which would require hospitals to collect and report patient outcome data over a longer period. Hospitals said the data collection would be far too burdensome.

The CMS's final decision dropped this claim, instead saying the agency would rely on patient information collected by the Food and Drug Administration and the National Cancer Institute. The FDA requires the two manufacturers of the therapy – Novartis and Gilead Sciences – monitor patients for years and report outcomes, such data will be entered in a register supported by NCI.

The icare decision also said it will cover the therapy when administered on health services registered in an FDA-mandated safety program that requires special training in the management of side effects. This means that treatment can be given on an outpatient basis, which would be much more affordable.

The American Society of Hematology praised the decision, especially the elimination of the "proof of coverage" requirement. It said the proposed mandate would have asked some hospitals not to provide CAR T-cell therapy.

The group also praised the decision to say that Medicare would cover all FDA-approved uses for CAR T-cell therapy and off-label use recommended in CMS-approved compendia, which are used to determine medically accepted drug and biology use.

The Medicare decision was the second step of a week taken by CMS to enhance CAR T-cell therapy. Last Friday, the agency said it would increase reimbursement for CAR T-cell therapy, but did not go as far as many hospitals had wished. Medical centers have complained about losing money to Medicare patients because reimbursements have been too low.

The FDA approved two versions of CAR T-cell therapy, which stands for chimeric antigen receptor T-cell, in 2017. Kymriah is made by Novartis for certain types of lymphoma and leukemia in children, and Yescarta is manufactured by Gilead Sciences for lymphoma. Other CAR T-cell therapy products are under development.

The complicated treatment involves extracting and genetically altering the patient's T cells to attack a protein on the surface of cancer cells. The cells are then infused back into the patient.

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