NEW YORK -- The UK's National Institute for Health and Care Excellence on Tuesday recommended that the autologous CAR T-cell therapy brexucabtagene autoleucel (Gilead/Kite's Tecartus) be made accessible through the Cancer Drugs Fund as an option for patients with relapsed or refractory mantle cell lymphoma treated within the UK's National Health Service.
In accordance with the recommendation, mantle cell lymphoma patients will be eligible for treatment with the autologous, anti-CD19-transduced, CD3-positive cells if they have previously received at least two prior lines of therapy, including a BTK inhibitor. According to a statement from NICE, there are currently 10 providers in the UK capable of administering the one-time treatment, and as such eligible patients may need to travel for treatment.
In its final appraisal document, NICE said that the ongoing ZUMA-2 clinical trial did not yet demonstrate sufficient long-term survival with brexucabtagene autoleucel and it remains to be seen whether the therapy can cure patients. NICE has therefore requested additional data on overall survival and progression-free survival, among other outcomes.
The ongoing data collection is part of a managed access agreement between NICE and Kite for brexucabtagene autoleucel, which also comprises an undisclosed price discount for the NHS. NICE's recommendation for the CAR T-cell therapy follows in the wake of the European Commission's conditional approval for the therapy, granted at the end of 2020, and the US Food and Drug Administration's accelerated approval, granted in July 2020.
Consultees and commentators have until Feb. 2 to appeal NICE's recommendation.