UK Knocks Down Yescarta as CAR T Therapy Gains European Authorization

Chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel, sold as Yescarta, was authorized earlier this week by the European Commission (EC) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after 2 or more lines of systemic therapy. This approval allows Yescarta to be available for use in the 28 countries of the European Union, Norway, Iceland, and Liechtenstein.

The Marketing Authorization Application (MAA) was approved based on data from the ZUMA-1 trial that investigated axicabtagene ciloleucel in adult patents with refractory aggressive non-Hodgkin lymphoma. In the single-arm trial that enrolled 101 participants, 72% of patients (n = 73) who received a single infusion of axicabtagene ciloleucel responded to therapy, with 51% ( n = 52) achieving a complete response.

There are currently 2 CAR T-cell therapies available on the market, and although both treatments have many benefits, they come at a steep price. Yescarta carries a US price tag of $373,000, and tisagenlecleucel, (sold as Kymriah for the treatment of pediatric and adult B-cell acute lymphoblastic leukemia) comes at the hefty price of $475,000 for a one-time dose.

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Just 1 day after the EC approved the treatments, the National Institute for Health and Care Excellence (NICE) deemed Yescarta too expensive to justify on Britain’s state-funded health service. While Yescarta was “an exciting innovation in very difficult to treat cancers, with a promise of a cure for some patients,” the price was too high for it to be considered cost-effective, said Meindert Boysen, director of the center for health technology evaluation at NICE. The United Kingdom list prices of the drugs have yet to be disclosed.

The developer of Yescarta, Kite Pharma, a subsidiary of Gilead, said in a statement that it was in “ongoing discussions with NICE to identify appropriate treatment comparators which can clarify how cell therapy may be made available to patients in the UK.” NICE’s evaluation of the cost-effectiveness of Kymriah is still ongoing.

Kymriah was the first CAR T-cell therapy approved in August 2017, and Yescarta followed shortly thereafter in October 2017.