Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure access to CAR-T therapy for mantle cell lymphoma patients who previously have been ineligible under the cancer drugs fund following NICE's most recent decision.

Decisions on whether new medicines should be routinely funded by the National Health Service in England are made by the National Institute for Health and Care Excellence (NICE) on the basis of an evaluation of their costs and benefits. NICE is currently re-evaluating brexucabtagene autoleucel (Tecartus) to determine whether it can be recommended for routine NHS use, taking into account real-world evidence generated through its use in the Cancer Drugs Fund.

NICE has been unable to recommend the treatment in the final draft guidance, which is available at the following link:

https://www.nice.org.uk/guidance/indevelopment/gid-ta11545/documents

This is because the available evidence does not suggest that brexucabtagene autoleucel is value for money in this population. Final guidance has not yet been published and the period to appeal NICE’s final draft recommendations closed on 19 January.

In line with an arrangement between NHS England and the company, if NICE’s final guidance does not recommend use, patients who started treatment during the managed access period can continue their treatment.