Subject: abiraterone-Zytiga 1934-A SGM P2022

Drug

ZYTIGA  (abiraterone)

abiraterone

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.

            A.  FDA-Approved Indications
                 1.  Indicated in combination with prednisone for the
                      treatment of patients with metastatic castration-
                      resistant prostate cancer (CRPC).
                 2.  Indicated in combination with prednisone for the
                      treatment of patients with metastatic high-risk
                      castration-sensitive prostate cancer (CSPC).

            B.  Compendial Uses
                 1.  Node-positive (N₁), non-metastatic (M₀) prostate cancer
                 2.  Very-high-risk prostate cancer

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

 
     II.  EXCLUSIONS

           Coverage will not be provided if the requested medication is
           used in combination with a second-generation oral anti-
           androgen (e.g., apalutamide [Erleada]) or an oral androgen
           metabolism inhibitor (e.g., fine-particle abiraterone acetate
           [Yonsa]).

 
   III.  CRITERIA FOR INITIAL APPROVAL

           Node positive,  metastatic and very-high-risk prostate
           cancer
           Authorization of 12 months may be granted for the treatment
           of node positive, metastatic or very-high-risk prostate cancer
           when the member has had a bilateral orchiectomy or will be
           using the requested medication in combination with a GnRH
           analog.

    IV.  CONTINUATION OF THERAPY

           Authorization of 12 months may be granted for continued
           treatment in members requesting reauthorization for an
           indication listed in Section III 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. Zytiga [package insert]. Horsham, PA: Janssen Biotech, Inc.; August 2021.
2. Abiraterone [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; November 2021.
3. IBM Micromedex^®DRUGDEX^® (electronic version). IBM Watson Heath, Greenwood Village, Colorado. Available at https://www.micromedexsolutions.com. Accessed July 6, 2022.
4. The NCCN Drugs & Biologics Compendium™ © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org Accessed July 6, 2022.
5. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology™ Prostate Cancer (Version 4.2022). https://www.nccn.org. Accessed July 6, 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.

December 29, 2022