Brexucabtagene autoleucel for treating relapsed or refractory mantle cell lymphoma

1.1 Treatment with brexucabtagene autoleucel is recommended for use within the Cancer Drugs Fund as an option for relapsed or refractory mantle cell lymphoma in adults who have previously had a Bruton's tyrosine kinase (BTK) inhibitor. It is only recommended if the conditions in the managed access agreement for brexucabtagene autoleucel treatment are followed.

1.2 This recommendation is not intended to affect either treatment in preparation for or treatment with brexucabtagene autoleucel 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 until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

There is no standard treatment for relapsed or refractory mantle cell lymphoma after a BTK inhibitor. Rituximab, bendamustine and cytarabine (R‑BAC) is the most common treatment option. Brexucabtagene autoleucel is a chimeric antigen receptor (CAR) T‑cell therapy. The therapy uses the patient's own T cells, which have been modified to attach to and kill cancer cells.

Evidence from a study of brexucabtagene autoleucel, which does not compare the therapy with anything else, suggests that people having it may live for longer and have more time before their disease relapses. However, the evidence is not certain because of the:

There is also not enough evidence to tell if people having treatment with brexucabtagene autoleucel can be cured.

Brexucabtagene autoleucel meets NICE's criteria to be considered a life-extending treatment at the end of life. This is because people having it are likely to live for less than 24 months, and this treatment could extend their life by at least 3 months. The most likely cost‑effectiveness estimates for brexucabtagene autoleucel compared with the most common alternative treatment are not known because the final survival data for brexucabtagene autoleucel are not yet available. However, early estimates suggest it could be cost effective, and collecting further data on progression-free survival, overall survival and age when treatment starts will reduce the uncertainty in the evidence. Therefore, brexucabtagene autoleucel is recommended for use as an option within the Cancer Drugs Fund.