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Oral azacitidine for maintenance treatment of acute myeloid leukaemia after induction therapy

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1 Recommendations

1.1 Oral azacitidine is not recommended, within its marketing authorisation, as maintenance therapy for acute myeloid leukaemia in adults who:

  • are in complete remission, or complete remission with incomplete blood count recovery after induction therapy, with or without consolidation treatment, and

  • cannot have or do not want a haematopoietic stem cell transplant.

1.2 This recommendation is not intended to affect treatment with oral azacitidine 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

There are no standard maintenance treatments available for all people with acute myeloid leukaemia (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 does not meet NICE's criteria to be considered a life-extending treatment at the end of life. This is because it is uncertain how long people who would be eligible for oral azacitidine live. The most likely cost-effectiveness estimates for oral azacitidine in all people with AML are higher than what NICE normally considers an acceptable use of NHS resources. So, oral azacitidine is not recommended for routine use in the NHS.

Oral azacitidine is not suitable for use within the Cancer Drugs Fund because further data collection would not resolve the uncertainty in the evidence. So oral azacitidine is not recommended for use within the Cancer Drugs Fund.