Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of chimeric antigen receptor T-cell therapies for treatment for cancers; and whether new medicines using these therapies this will be approved.

NHS England funds the use of licensed medicines that have been recommended by the National Institute for Health and Care Excellence (NICE), or the off-label use of licensed medicines that have been approved via the NHS England clinical policy process.

NICE has evaluated and recommended several CAR-T therapies for both high-grade and low-grade lymphomas, some of which are recommended for a period of managed access:

• Brexucabtagene autoleucel, which includes relapsed or refractory mantle cell lymphoma (managed access) and/or relapsed or refractory B-cell acute lymphoblastic leukaemia in people 26 years old and over (managed access);
• Tisagenlecleucel, which includes relapsed or refractory B-cell acute lymphoblastic leukaemia in people 25 years old and under;
• Axicabtagene ciloleucel, which includes diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after two or more systemic therapies and/or relapsed or refractory diffuse large B-cell lymphoma after first-line chemoimmunotherapy;
• Lisocabtagene maraleucel, which includes relapsed or refractory large B-cell lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable;
• Obecabtagene autoleucel, which includes relapsed or refractory B-cell acute lymphoblastic leukaemia; and
• relapsed or refractory B-cell acute lymphoblastic leukaemia.

To support implementation of NICE recommendations, NHS England sets clinical treatment criteria to ensure that treatments are made available to those intended by the NICE guidance. Clinical input helps set the clinical and patient treatment criteria based on the NICE committee deliberations, how the treatment will be used within the treatment pathway, and the evidence base considered by NICE and the Medicines and Healthcare products Regulatory Agency.