Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the consequences for patients with mantle cell lymphoma of NICE’s decisions not to recommend (1) brexucabtagene autoleucel, and (2) acalabrutinib with bendamustine and rituximab; and what steps they plan to take to resolve the uncertainties identified in the evidence to support the use of brexucabtagene autoleucel, given that its use has not been recommended, and it will therefore not add to further data.

The National Institute for Health and Care Excellence (NICE) is an independent body and develops its recommendations in line with its established processes on the basis of an assessment of clinical and cost effectiveness. It is right that these decisions are made independently on the basis of the available evidence, and the Government has no plans to intervene in NICE’s decisions. Companies may, however, bring forward further evidence or revised commercial proposals for future consideration through NICE’s established processes.

The Government recognises that the potential withdrawal of brexucabtagene autoleucel as a treatment for future patients with mantle cell lymphoma will be concerning for patients and their families, but it is important to note that final guidance has not yet been published and an appeal is ongoing. 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.

NICE has recently consulted on its draft guidance that does not recommend acalabrutinib in combination with bendamustine and rituximab for the treatment of untreated mantle cell lymphoma. NICE will take the comments received in response to the consultation fully into account in developing its final guidance.