Subject: Onureg SGM 4194-A P2026

Drug

ONUREG  (azacitidine)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications¹

Onureg is indicated for continued treatment of adult patients with acute myeloid leukemia (AML) 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.

Compendial Uses²

·        AML

·        Peripheral T-Cell Lymphomas

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Acute Myeloid Leukemia (AML)^1,2

Authorization of 12 months may be granted for treatment of non-core binding factor (non-CBF) AML when all of the following criteria are met:

·        The requested medication will be used as a single agent.

·        The member has achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy.

·        The member is not able to complete intensive curative therapy.

Peripheral T-Cell Lymphomas (PTCL)²

Authorization of 12 months may be granted for the treatment of peripheral T-cell lymphomas (PTCL) [including the following subtypes: angioimmunoblastic T-cell lymphoma (AITL), nodal peripheral T-cell lymphoma with TFH phenotype (PTCL, TFH), follicular T-cell lymphoma (FTCL)] when all of the following criteria are met:

·        The requested medication will be used as subsequent therapy for relapsed, refractory, or progressive disease

·        The requested medication will be used as a single agent

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Onureg [package insert]. Princeton, NJ: Celgene Corporation; October 2022.

2.     The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed December 30, 2025.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 14, 2026