The European Commission (EC) has approved the use of Novartis’s tisagenlecleucel (Kymriah) and Gilead’s axicabtagene ciloleucel (Yescarta), two chimeric antigen receptor T cell (CAR T) therapies. Already approved by the FDA at the end of 2017, these therapies have been hailed as a breakthrough in cancer treatment by using a patient’s own T cells to combat malignant cells.
Kymriah, the first CAR T-cell therapy ever approved by the FDA, treats B-cell acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL). Yescarta is approved for diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL).
Shortly after the EC approval, the National Institute for Health and Care Excellence (NICE) in the United Kingdom issued a draft guidance stating that Yescarta is too expensive to justify its use in the National Health Service (NHS). Currently, the list price for Yescarta in the United States is $373,000. The draft recommendation is open for comment until September 18, and NICE will meet to discuss the feedback on September 27. The agency is still evaluating Kymriah (listed at $475,000 in the United States).
CAR T therapies will continue to face challenges around reimbursement well into the future, as the cost associated with developing and manufacturing these autologous treatments is high. At Akron, we are working closely with our partners to control the cost of goods associated with the production of these treatments, innovating to make our cGMP ancillary materials more affordable so that they can be introduced at earlier stages in the product development process. Please reach out to learn more about how we can help you contain your cost of goods, ultimately facilitating your product’s transition to market.