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Axicabtagene ciloleucel for treating relapsed or refractory diffuse large B-cell lymphoma after 1 systemic treatment

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1 Recommendations

1.1 Axicabtagene ciloleucel is not recommended, within its anticipated marketing authorisation, for treating diffuse large B-cell lymphoma that has relapsed within 12 months after first-line chemoimmunotherapy, or is refractory to first-line chemoimmunotherapy, in adults.

1.2 This recommendation is not intended to affect treatment with axicabtagene ciloleucel that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Standard care for relapsed or refractory diffuse large B-cell lymphoma after 1 systemic treatment is chemotherapy followed by high-dose chemotherapy and autologous stem cell transplant. Axicabtagene ciloleucel is a chimeric antigen receptor (CAR) T-cell therapy. It uses the person's own immune system cells (T‑cells), which have been modified to attach to and kill cancer cells. It would be used as an alternative to chemotherapy followed by high-dose chemotherapy and autologous stem cell transplant.

Clinical trial evidence suggests that, when autologous stem cell transplant is suitable, axicabtagene ciloleucel improves how long people live compared with standard care. But it is uncertain by how much because the trial is not yet complete. Some people in the trial who had standard care went on to have a CAR T-cell therapy. This is not standard care in the NHS, so adjusting the data to reflect this also adds uncertainty.

Axicabtagene ciloleucel meets NICE's criteria to be considered a life-extending treatment at the end of life. But even taking this into account, all the cost-effectiveness estimates are above the range NICE normally considers an acceptable use of NHS resources. So, axicabtagene ciloleucel is not recommended for routine use in the NHS.

Axicabtagene ciloleucel has not been shown to have the potential to be cost effective. So, axicabtagene ciloleucel is not recommended for use in the Cancer Drugs Fund.