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NICE Backs Gilead Sciences' Yescarta as Third-Line Option for Lymphoma Patients

NEW YORK – The UK's National Institute for Health and Care Excellence on Thursday recommended that the National Health Service provide Gilead Sciences' autologous CAR T-cell therapy Yescarta (axicabtagene ciloleucel) as a third-line option for patients in England with relapsed or refractory diffuse large B-cell lymphoma.

Yescarta has been available in England for several years through the Cancer Drugs Fund, allowing for more data to be gathered on the treatment's benefits. In its final draft recommendation, NICE has now recommended Yescarta for routine use after the NHS Commercial Medicines Directorate struck a confidential pricing deal with Gilead. Yescarta's list price is £280,451 ($347,200) for a 68-ml single-infusion bag, but Gilead is making the drug available to the NHS at an undisclosed discount.

To make its decision, NICE's independent appraisal committee considered clinical trial data as well as data from 318 patients who accessed Yescarta through the Cancer Drugs Fund between December 2018 and October 2021. The committee concluded, based on this data, that Yescarta improves progression-free survival time versus chemotherapy in this patient population. Among patients treated through the Cancer Drugs Fund, the median overall survival time was 28.5 months. After three years, 45 percent of Yescarta-treated patients were still alive. In contrast, Gilead estimated a median overall survival of 6.4 months among patients receiving salvage chemotherapy.

The autologous cell therapy has widespread approval as a lymphoma treatment already. In the US and Europe, Yescarta has been a third- or later-line option for refractory DLBCL patients for years, and last year the US Food and Drug Administration and European Commission approved it as a second-line treatment for refractory DLBCL patients.

"Five years ago the NHS led the way in Europe by striking commercial deals for revolutionary CAR-T cancer treatment, and today we have used our commercial capabilities to reach a deal that secures long-term patient access to this personalized therapy," John Stewart, the director of specialized commissioning and interim director of commercial medicines at NHS England, said in a statement. "This advanced therapy has been commissioned through the Cancer Drugs Fund since 2018, allowing evidence to be collected that confirms its benefits for patients facing this aggressive form of lymphoma and now enables the NHS to provide routine access at a fair price for taxpayers."