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New HTA Decisions in England
August 2020
Drug name
XOSPATA® (gilteritinib)
Astellas Pharma
Decision date
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood and bone marrow cancers
Gilteritinib monotherapy is recommended as an option for treating relapsed or refractory FLT3‑mutation-positive acute myeloid leukaemia (AML) in adults.
Decision Detail
Only if: the company provides gilteritinib according to the commercial arrangement; Gilteritinib should not be given as maintenance therapy after a haematopoietic stem cell transplant. There is a simple discount patient access scheme for gilteritinib.
The clinical evidence came from ADMIRAL, an open-label, randomised trial, which compared gilteritinib with the investigator's choice of salvage chemotherapy. The primary outcome measure in ADMIRAL was overall survival. In response to consultation the company provided updated data from the ADMIRAL study (September 2019 data cut). Treatment with gilteritinib increased median overall survival compared with salvage chemotherapy from 5.6 months to 9.3 months (hazard ratio 0.68; 95% confidence interval 0.53 to 0.88, p=0.0013). The committee concluded that salvage chemotherapy was an appropriate comparator. However, there is considerable uncertainty about long-term survival, particularly after stem cell transplant. There is no robust evidence of further benefit if someone restarts gilteritinib after stem cell transplant when they have had it before the transplant. Applying the committee's preferred assumptions and including all commercial arrangements in the model resulted in an ICER which was below £50,000 per QALY gained for gilteritinib compared with salvage chemotherapy (the ICER is confidential and cannot be reported here). Based on the evidence presented to it, the committee concluded that, with the discount agreed in the commercial arrangement, the most plausible ICER was within the range that NICE normally considers an acceptable use of NHS resources for a life-extending treatment at the end of life. Therefore, it recommended gilteritinib as an option for treating relapsed or refractory FLT3 mutation-positive AML in adults, although people whose disease responds to gilteritinib and who then go on to have a stem cell transplant should not restart gilteritinib after transplant.