Subject: Onureg 4194-A SGM P2022

Drug

ONUREG  (azacitidine)

Policy:

      I.   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 Indications
            Onureg is 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. 

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

 
      II.  CRITERIA FOR INITIAL APPROVAL

            Acute Myeloid Leukemia (AML)
            Authorization of 12 months may be granted for treatment of
            AML when all of the following criteria are met:
            1.  The requested medication will be used as a single agent.
            2.  The member has achieved first complete remission (CR) or
                 complete remission with incomplete blood count recovery
                 (CRi) following intensive induction chemotherapy.
            3.  The member is not able to complete intensive curative
                 therapy.

 
    III.  CONTINUATION OF THERAPY

            Authorization of 12 months may be granted for continued
            treatment in members requesting reauthorization for an
            indication listed in Section II 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]. Summit, NJ: Celgene Corporation; May 2021.

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 26, 2022