Gilteritinib will not be available on the NHS as a treatment option for relapsed or refractory FLT3-mutation-positive acute myeloid leukaemia (AML) in adults, according to draft NICE guidance.
The clinical evidence presented to support the application came from the open-label randomised ADMIRAL trial which compared gilteritinib with the investigator’s choice of salvage treatment, including low-dose cytarabine (LoDAC); azacitidine, mitoxantrone, etoposide and cytarabine (MEC); fludarabine, idarubicin, granulocyte-colony stimulating factor and high-dose cytarabine (FLAG-IDA).
Treatment with gilteritinib was found to be associated with increased median overall survival compared with salvage chemotherapy from 5.6 months to 9.3 months (HR 0.64; 95% CI 0.49-0.83, P<0.001).
However NICE had concerns about the source of the values used in the calculation of the hazard ratio between gilteritinib and best supportive care was unclear. Furthermore, NICE’s expert group pointed out that proportional hazards are assumed, which may not be appropriate because it is not clear whether the assumption was assessed.
The most likely cost-effectiveness results showed that gilteritinib is above the level normally considered a cost-effective use of NHS resources and, therefore, gilteritinib will not be recommended for routine use in the NHS.
The draft decision is open to public comment until 5 February 2020.
