Subject: Onureg 4194-A SGM P2023

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 Indication
          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]. Princeton, NJ: Celgene Corporation; October 2022.

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 18, 2023