1 Recommendations
1.1 Oral azacitidine is recommended, within its marketing authorisation, as an option for maintenance treatment for acute myeloid leukaemia (AML) in adults who:
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are in complete remission, or complete remission with incomplete blood count recovery, after induction therapy with or without consolidation treatment, and
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cannot have or do not want a haematopoietic stem cell transplant.
It is recommended only if the company provides oral azacitidine according to the commercial arrangement.
Why the committee made these recommendations
There are no standard maintenance treatment options for most people with AML who cannot have or do not want a haematopoietic stem cell transplant. Some people with FLT3-mutation-positive AML can have targeted maintenance treatment with midostaurin. Therefore, oral azacitidine would likely be of most benefit to people whose AML does not have an FLT3-mutation. The clinical trial evidence shows that if people take oral azacitidine it takes longer for their cancer to relapse, and they live longer than if they have placebo.
Oral azacitidine meets NICE's criteria to be considered a life-extending treatment at the end of life. The most likely cost-effectiveness estimates for oral azacitidine are within what NICE normally considers an acceptable use of NHS resources for end of life treatments. So, oral azacitidine is recommended.