Pharmacy Prior Authorization Criteria

Onureg (azacitidine)

Indications for Prior Authorization

Onureg (azacitidine)

• For diagnosis of Acute Myeloid Leukemia (AML)
  Indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

Criteria

Onureg

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of acute myeloid leukemia (AML)
AND
• Patient has received previous treatment with an intensive induction chemotherapy regimen (e.g., cytarabine + daunorubicin, cytarabine + idarubicin, etc.) [2]
AND
• Patient has achieved one of the following:
• first complete remission (CR)
• complete remission with incomplete blood count recovery (CRi)
AND
• Patient is not able to complete intensive curative therapy

Onureg

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-09-19, 2023-12-01, 2023-07-05, 2022-11-02, 2021-10-08, 2021-09-27, 2021-05-21, 2020-10-27

References

1. Onureg prescribing information. Celgene Corporation. Summt, NJ. October 2022.
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia. v3.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/aml.pdf. Accessed September 19, 2024.

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Revision History

• 2024-09-19: 2024 Annual Review. No clinical changes. Updated references.
• 2023-12-01: 2023 Annual review. Updated references.
• 2023-07-05: Removed specialist requirement
• 2022-11-02: 2022 Annual Review
• 2021-10-08: 2021 Annual Review
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2020-10-27: New program

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