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WASHINGTON — In a major test case, Medicare is poised to cover a promising but expensive new type of cancer treatment, with significant restrictions meant to hold down the cost.
Cancer patients, doctors and drug companies are urging the Trump administration to remove the restrictions and broaden coverage so more patients can benefit from the treatment, known as CAR T cell therapy, or CAR-T. But insurance companies are pushing for the restrictions.
The treatment is manufactured specifically for each patient, and many more such “personalized medicines” are in the pipeline. Medicare’s final decision, expected in the next few weeks, will influence commercial insurers and state Medicaid programs, which often follow its lead.
Medicare and other insurers typically pay for drugs as they are used, from month to month and year to year. By contrast, the CAR-T treatments generate high costs up front, but the benefits could last for years.
The Food and Drug Administration has approved two CAR-T products to treat certain blood cancers: Kymriah, made by Novartis, with a list price of $373,000 or $475,000, depending on the type of cancer, and Yescarta, made by Gilead Sciences, with a list price of $373,000.
The treatments have been remarkably effective in some patients who had a dismal prognosis after exhausting other options. Researchers around the country are conducting more than 450 clinical trials to explore other uses of CAR-T medicines that work in similar ways.
The Trump administration has proposed covering CAR-T therapy when it is prescribed by a cancer specialist and given in a hospital to Medicare patients whose cancer has not responded to other treatments like chemotherapy and radiation. Medicare would also cover the treatment for patients whose cancer returns, causing a relapse after a period of improvement.
Seema Verma, the administrator of the Centers for Medicare and Medicaid Services, has described CAR-T as “an entirely new approach to treating serious and even life-threatening diseases.”
Dr. Francis S. Collins, the director of the National Institutes of Health, said that harnessing the power of a patient’s immune system in this way was a “marvel of modern medicine.” But “because of the need to personalize the preparation of cells for every patient,” he said, “costs are quite high, and it could be truly challenging to scale up use of the technology.”
Officials will increasingly confront such challenges as they try to ensure that Medicare beneficiaries have access to the latest treatments at an affordable cost.
CAR-T therapy sounds like science fiction. Immune cells — T cells — are removed from a patient’s blood, sent to a laboratory where they are genetically engineered to recognize and attack cancer cells, and then sent back to the hospital for infusion into the patient.
The total cost of treatment, including the CAR-T infusion, doctors’ services and hospital stays, can easily exceed…