1 Recommendations

1.1 Gilteritinib is not recommended, within its marketing authorisation, for treating relapsed or refractory FLT3‑mutation-positive acute myeloid leukaemia in adults.

1.2 This recommendation is not intended to affect treatment with gilteritinib 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

Relapsed or refractory FLT3‑mutation-positive acute myeloid leukaemia is usually treated with salvage chemotherapy (a type of chemotherapy offered when a first course of chemotherapy has not worked, or the disease has come back after treatment). Gilteritinib is an alternative treatment taken as an oral tablet at home, which is an important quality-of-life benefit for patients.

The clinical evidence shows that people having gilteritinib live longer compared with people having salvage chemotherapy. However, there is uncertainty about long-term survival, particularly after stem cell transplant. This makes the cost-effectiveness results uncertain.

The most likely cost-effectiveness results show that gilteritinib is above the level normally considered a cost-effective use of NHS resources. Therefore, gilteritinib is not recommended for routine use in the NHS.