- Food and Drug Administration Commissioner Scott Gottlieb stressed the need for reform on the reimbursement side of medicine, calling it an "ossified paradigm" that could weigh on cutting-edge therapies like CAR-T cancer therapy.
- "There are places where I am extremely worried that if we don't adapt the approach to reimbursement soon, we may foreclose therapeutic opportunities," Gottlieb said Wednesday at the Milken Institute's annual Future of Health Summit in Washington.
- The FDA head referenced how radiopharmaceuticals were treated in reimbursement, "underpaying hospitals and forcing them to lose money." Gottlieb warned the same thing is happening now with CAR-T.
Once again, Gottlieb waded into topics that his agency doesn't directly work on. Generally, reimbursement in government-sponsored health insurance falls to the Centers for Medicare and Medicaid Services, while private insurers make their own decisions on covering the medical costs.
Gottlieb contrasted a "highly nimble, highly innovative" model for developing drugs that target rare diseases to an "ossified" reimbursement system. He lamented how radioactive pharmaceuticals had "some good drugs at the time that worked" but are no longer used due to reimbursement issues, directly comparing that experience to what CAR-T may face.
"We're doing the same thing with CAR-T right now," he said. "I think we have a window of opportunity to think about how we are going to reimburse that appropriately. There are things that FDA can potentially do in terms of how we label the products, but we're going to need to think about what are appropriate reimbursement ... for these novel therapies."
In April, CMS announced it would reimburse hospitals roughly $400,000 for Gilead Sciences' Yescarta (axicabtagene ciloleucel) and about $500,000 for Novartis' Kymriah (tisagenlecleucel) for Medicare Part B beneficiaries.
Gottlieb also noted the agency is focused on combating high drug prices through an emphasis on high-value generic opportunities and encouraging second- or third-to-market therapies.
Additionally, the commissioner foreshadowed FDA data it will "put out soon" that shows lengthening times between the arrival of a first-in-class product and entry of subsequent therapies.
"There is a sense that if you think you'll be third to market, you pull out," he commented. "And so, we are seeing less competition in these categories. To the extent that innovators are having monopolies for longer periods of time or in perpetuity, that's not just creating an environment for prices to stay higher for longer, but it's also foreclosing opportunity for therapeutic variety within categories."