Subject: abiraterone products SGM 1934-A P2024a

Drug

abiraterone products

ZYTIGA  (abiraterone)

ABIRTEGA  (abiraterone)

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 Indications^1-3

• Indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
• Indicated in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC).

Compendial Uses^4-6

• Node-positive (N₁), non-metastatic (M₀) prostate cancer
• High-risk, non-metastatic prostate cancer
• Very-high-risk prostate cancer
• Salivary gland tumor

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

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]).

Coverage Criteria

Prostate Cancer^1-6

Authorization of 12 months may be granted for the treatment of prostate cancer when both of the following criteria are met:

• The member has had a bilateral orchiectomy or will be using the requested medication with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix)
• The member meets either of the following criteria:
  • The disease is non-metastatic and the disease is node positive, high-risk, or very-high-risk
  • The disease is metastatic

Salivary Gland Tumor⁵

Authorization of 12 months may be granted for treatment of recurrent, unresectable, or metastatic salivary gland tumor in combination with prednisone when the tumor is androgen receptor positive.

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. Zytiga [package insert]. Horsham, PA: Janssen Biotech, Inc.; August 2021.
2. Abiraterone [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; November 2021.
3. Abirtega [package insert]. Lehi, UT: CivicaScript, LLC.; October 2024.
4. IBM Micromedex®DRUGDEX® (electronic version). IBM Watson Heath, Greenwood Village, Colorado. Available at https://www.micromedexsolutions.com. Accessed August 6, 2024.
5. The NCCN Drugs & Biologics Compendium™ © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org Accessed August 6, 2024.
6. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology™ Prostate Cancer (Version 4.2024). https://www.nccn.org. Accessed August 6, 2024.
7. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Head and Neck Cancers. Version 4.2024. Accessed August 6, 2024. https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf.

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.

April 25, 2025