Gilead CAR-T drug Yescarta turned away by NICE cost-effectiveness watchdogs

Gilead
Gilead's Yescarta is too expensive to recommend, cost watchdogs in England determined. (Gilead China)

Only one day after Gilead’s CAR-T drug Yescarta picked up its European approval, England's influential cost watchdogs have stiff-armed the drug because of its high price.

The National Institute for Health and Care Excellence said Tuesday that Yescarta is a “step-change in treatment” for patients who have no other options, but that the drug’s price—which the agency did not disclose—is too high to be considered a cost-effective use of the National Health Service's resources. Despite the decision, a Gilead spokesman said the company believes it will be able to reach a deal.

The company submitted the price as "commercial in confidence," according to NICE documents. Yescarta, developed by Gilead's Kite Pharma unit, is EU-approved to treat diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma after two prior therapies.

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Novartis’ CAR-T med Kymriah also won European approval Monday. NICE is reviewing the drug, according to its website. CAR-T drugs are made of a patient’s own T cells that are collected, re-engineered to attack cancer and then infused back into the patient.

“Although promising, there is still much more we need to know about CAR-T, and unfortunately, in this case, we are not able to recommend axicabtagene ciloleucel for use in the NHS in England at the cost per patient set by Kite Pharma,” Meindert Boysen, director of the center for health technology evaluation at NICE, said in a statement.

RELATED: Gilead to build its EU CAR-T manufacturing facility at Amsterdam airport 

Now, NICE is asking for feedback about how to fund the drug. Its expert appraisal committee considered covering Yescarta through the Cancer Drugs Fund for now but decided the drug doesn’t have “plausible potential to be cost-effective” for a short-term funding agreement.  

A Gilead spokesman said the company's "priority is to make axicabtagene ciloleucel available to patients in the UK as soon as possible and as such we believe we will soon be able to reach an agreement."

"Cell therapy is a new and advanced technology and, as NICE has identified, there is little available data about the salvage treatment of patients with aggressive forms of non-Hodgkin lymphoma (NHL) in England," he added. "We’re therefore 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."

Oftentimes, NICE will reject expensive drugs initially and strike a deal after further negotiations. That’s not always the case, though, and the agency’s reviews have irked pharma as innovative-but-pricey drugs exceed the agency’s cost-effectiveness thresholds. 

Earlier this month, NICE rejected another superpricey therapy in Biogen’s spinal muscular atrophy med Spinraza. At the time, Boysen said the agency is “actively engaging with Biogen to discuss how they might address the uncertainties" the agency highlighted in its rejection. 

Meanwhile, Vertex Pharmaceuticals and the U.K. government are locked in a dispute over the company's cystic fibrosis drug Orkambi. The med has been approved in Europe for three years, but U.K. patients still don’t have access to it, first because of a NICE rejection and now because Vertex and the NHS have been unable to strike a pricing deal.

Gilead picked up Kite last year for $11.9 billion. The company previously said it would build a CAR-T plant at the Amsterdam airport to reduce shipping timelines for European markets. Novartis has experienced CAR-T manufacturing issues in the U.S. and on Monday announced plans for a new CAR-T plant in Switzerland that could eventually employ 450 people.

Editor's note: This story was updated with a statement from Gilead.

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