Subject: Zytiga 1934-A SGM P2021

Drug

ZYTIGA  (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 Indication
       1.   Indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.
       2.   Indicated in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer. 

 B.   Compendial Uses 
       Node-positive (N₁), non-metastatic (M₀) 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 or metastatic prostate cancer
       Authorization of 12 months may be granted for the treatment of node positive or metastatic 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.; October 2020.
2. Abiraterone [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; March 2021.
3. IBM Micromedex^®DRUGDEX^® (electronic version). IBM Watson Heath, Greenwood Village, Colorado. Available at https://www.micromedexsolutions.com. Accessed July 6, 2021.
4. The NCCN Drugs & Biologics Compendium™ © 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org Accessed July 6, 2021.
5. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology™ Prostate Cancer (Version 2.2021). https://www.nccn.org. Accessed July 6, 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.

November 17, 2021