lisocabtagene maraleucel (Breyanzi)

following a full submission:

lisocabtagene maraleucel (Breyanzi®) is accepted for use within NHSScotland.

Indication under review: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

In an open-label, phase III study, lisocabtagene maraleucel statistically significantly improved event-free survival compared with salvage chemoimmunotherapy, followed by high-dose chemotherapy and autologous stem cell transplantation. This approach may now be relevant only to a small subset of patients. Indirect evidence suggests no meaningful difference in efficacy between lisocabtagene maraleucel and axicabtagene ciloleucel, the most relevant treatment, although some safety outcomes may favour lisocabtagene maraleucel.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.