Cancer patients, physicians and pharmaceutical companies are urging the Trump administration to expand access to CAR-T therapy, an expensive new type of cancer treatment that could help save thousands of lives. In a major test case this week, Medicare appears poised to cover the treatment—but with significant restrictions meant to keep costs low, The New York Times reports.
The Food and Drug Administration (FDA) has approved two CAR-T products to treat certain blood cancers. The drugs are manufactured specifically for each patient and are considered the first of many “personalized medicines” coming down the treatment pipeline. Medicare’s final decision on whether or not to cover CAR-T therapy, expected over the next few weeks, will influence commercial insurers and state Medicaid programs, which usually follow the Centers for Medicaid and Medicare Services’ lead.
However, the drugs are expensive. The drug Kymriah, made by Novartis, for example, has a list price of between $373,000 or $475,000 per patient. (The price depends on the type of cancer.) Yescarta, made by Gilead Sciences, costs $373,000. The total cost of treatment, including the CAR-T infusion, doctors’ visits and hospital stays can exceed $750,000.
In order to help keep payers’ costs low, under the Trump administration proposal, Medicare would pay only for CAR-T therapy for patients whose cancer has relapsed or for those with refractory cancer, meaning it has resisted other treatments. Advocates say the proposed rules are too limiting and could delay treatment for patients who are very ill.
“Let the doctor decide which patients should be eligible,” said Kirsten A. Sloan, a vice president of the American Cancer Society’s Cancer Action Network. “We have a new therapy, a result of years of research, and it has been approved by the FDA. Let’s make sure people have access to it.”
However, Trump administration officials are standing by their decision. “CAR-T cell therapy shows promise,” they wrote in a 39,000-word decision memo last week, but “the evidence is inadequate to confidently conclude” that it will improve health outcomes for Medicare beneficiaries, the Times reported.
To learn more about CAR-T therapy, click here.