Question to the Department of Health and Social Care:

To ask His Majesty's Government which specific CAR-T treatments are available for individuals with low grade lymphomas.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

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 indications 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, for instance:

• Brexucabtagene autoleucel, for relapsed or refractory mantle cell lymphoma (MA rec) and/or relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged 26 years old and over (managed access);
• Tisagenlecleucel for relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged 25 years old and under;
• Brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma (managed access) and/or relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged 26 years old and over (managed access);
• Tisagenlecleucel for relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged 25 years old and under;
• Axicabtagene ciloleucel for 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 for relapsed or refractory large B-cell lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable; and
• Obecabtagene autoleucel for relapsed or refractory B-cell acute lymphoblastic leukaemia and/or 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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what support they are providing to NHS Trusts to restore or replace paused CAR-T clinical trials, to prevent patients being left without viable treatment pathways.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

The Department is committed to turbocharging clinical research and ensuring that all patients, including those with cancer, have access to cutting-edge clinical trials and innovative, lifesaving treatments.

Decisions about whether a specific clinical trial should be paused are the responsibility of the study sponsor and research team, who closely monitor any reported patient safety concerns and other data that could impact a decision for an individual trial to be halted.

To support National Health Service trusts to deliver clinical trials, the Department funds research and research infrastructure across England through the National Institute for Health and Care Research, which supports patients and the public to participate in high-quality research, including on CAR-T therapy.

Question to the Department of Health and Social Care:

To ask His Majesty's Government whether they have carried out an impact assessment on the effect of halted CAR-T clinical trials, and whether they will publish that assessment.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

The Department is committed to turbocharging clinical research and ensuring that all patients, including those with cancer, have access to cutting-edge clinical trials and innovative, lifesaving treatments.

The Department has not carried out an impact assessment on the effect of halted CAR-T clinical trials. This is because decisions about whether a specific clinical trial should progress or not are the responsibility of the study sponsor and research team involved, who closely monitor any reported patient safety concerns and other data that could impact this decision.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what the current NHS eligibility criteria are for CAR-T therapy for both high-grade and low-grade lymphomas.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

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 indications 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, for instance:

• Brexucabtagene autoleucel, for relapsed or refractory mantle cell lymphoma (MA rec) and/or relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged 26 years old and over (managed access);
• Tisagenlecleucel for relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged 25 years old and under;
• Brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma (managed access) and/or relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged 26 years old and over (managed access);
• Tisagenlecleucel for relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged 25 years old and under;
• Axicabtagene ciloleucel for 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 for relapsed or refractory large B-cell lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable; and
• Obecabtagene autoleucel for relapsed or refractory B-cell acute lymphoblastic leukaemia and/or 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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government how many clinical trials offering CAR-T therapy for low-grade lymphoma have closed in the last three years, and what the reasons were in each case.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

Answering this question would require Medicines and Healthcare products Regulatory Agency staff to go through a vast volume of protocol documents manually. This is because the information is not held in such a way to be able to filter electronically by the requested category.

The Guide to Parliamentary Work sets out that there is an advisory cost limit known as the disproportionate cost threshold which is the level above which departments can decide not to answer a written question. The current disproportionate cost threshold is £850.

The Guide to Parliamentary Work is published online and is available on the GOV.UK website.