Reimbursement uncertainties hinder patient access to CAR-T therapies

The approval of CAR-T therapies Kymriah® and Yescarta® in late 2017 represented an enormous milestone for patients with leukemia, lymphoma, and other blood cancers. However, the ongoing uncertainty over reimbursement has made it difficult for patients to access the CAR-T treatments. Despite the months passed since the therapies were FDA approved, only some patients that could benefit from such therapies have been treated, and waiting lists are long.

One of the biggest challenges associated with CAR-T therapies is the cost. Novartis’s Kymriah costs $475,000, while Gilead’s Yescarta comes in at $373,000. And those price tags only cover a single step in the multi-step process of CAR-T administration; they don’t account for hospital stays, patient apheresis or chemotherapy. Those added elements further complicate the billing and reimbursement steps.

“Most manufacturers are used to the world of drugs,” said Susan Leppke, director of Health and Public Policy at the National Marrow Donor Program® (NMDP)/Be The Match®, the parent company of Be The Match BioTherapies®. “A CAR-T therapy is a treatment—yes, it’s a drug, but there’s a whole mechanism involved that’s not just the drug.”

That mechanism has additional costs associated with it, bringing the total cost of administering a CAR-T therapy to a single patient closer to $600,000 or even greater than $1 million. Those costs, which vary widely depending on a number of factors such as a patient’s age and health comorbidities, create a challenge for agencies like the Centers for Medicare & Medicaid Services, who are trying to fit this new therapy in the existing Medicare payment model.

In the meantime, “some patients aren’t able to get in the door due to long waitlists to get these therapies,” according to Leppke. That’s where her team comes in. They’re dedicated to analyzing the complex health care system and working with and facilitating dialogue between the numerous players involved, such as payers, manufacturers, hospitals, and ultimately, patients themselves, to break down barriers to access.

Their work involves advocating for legislation for greater insurance coverage for cell therapies, facilitating and guiding discussions with manufacturers and conducting analyses on the economic impact of different pricing models.

“This work is essential to our core mission to save lives through cellular therapy. We exist to serve patients, and breaking down barriers between patients and the treatments they need will always be a top priority for us,” said Leppke.

And, her team is looking even further into the future—toward speeding patient access to the next wave of CAR-T therapies. As treatments evolve, they’re likely to become safer and simpler to deliver, resulting in shorter hospital stays and lower costs overall.

“As a medical community, we’re learning to take a more holistic approach toward delivering therapies,” she said. “I’m very excited to be part of that change, because at the end of the day, we’re all trying to save lives by using these cellular therapies to help patients, and we can only do that by working together.”