Azacitidine [AZA1]

Oral azacitidine as maintenance therapy newly diagnosed AML patients in remission following at least induction chemotherapy and who are not candidates for, or who choose not to proceed to, haemopoietic stem cell transplantation where the following treatment criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with oral azacitidine will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has newly diagnosed acute myeloid leukaemia (AML).
3. The patient has been treated with standard intensive cytarabine-based induction chemotherapy.
4. The patient has either received any consolidation chemotherapy or not. Please mark below whether consolidation chemotherapy was received or not:

• no consolidation chemotherapy was administered
• at least one cycle of consolidation chemotherapy was given

5. The patient is currently in complete remission (CR) or is in complete remission with incomplete blood count recovery (CRi). Please mark below as to whether the patient is in CR or CRi.

• CR
• Cri

6. The patient is not a candidate for, or has chosen not to proceed to, haemopoietic stem cell transplantation (HSCT). Please mark below the reason for not undergoing haemopietic stem cell transplantation:

• the patient is not medically fit for HSCT in - there is no suitable donor for HSCT
• the patient has chosen not to proceed to HSCT
• there is another reason for not proceeding to HSCT

7. Maintenance therapy with oral azacitidine will be as monotherapy.
8. Oral azacitidine maintenance therapy will be continued until disease progression up to a maximum of 15% blasts is observed in peripheral blood/bone marrow or until unacceptable toxicity occurs or there is withdrawal of patient consent, whichever is the sooner.
9. The prescribing clinician understands that the usual 300mg once daily 14-day treatment schedule every 28 days for oral azacitidine can be extended to a 21-day treatment schedule every 28 days if a disease relapse with a blast count of 5-15% is observed in the peripheral blood or bone marrow. Note: oral azacitidine must be discontinued if the blast count exceeds 15% in the peripheral blood or bone marrow.
10. The patient is fit for treatment with oral azacitidine maintenance therapy and has an ECOG performance status (PS) of 0-3. Please mark below the ECOG PS status:

• PS 0
• PS 1
• PS 2
• PS 3

11. The prescribing clinician understands that oral azacitidine can only be prescribed in this maintenance indication in this group of AML patients and cannot be used interchangeably with injectable azacitidine.
12. A formal medical review as to whether treatment with oral azacitidine should continue will occur at least by the end of the second cycle of treatment.
13. Where a treatment break of more than 10 weeks beyond the expected cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID 19.
14. Azacitidine will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 02 September 2022

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA827 (05 October 2022)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.