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Zytiga (abiraterone acetate) - Commercial and Healthcare Reform
Number: J-726 Category: Prior Authorization
Line(s) of Business:

Healthcare Reform


Commercial (1.):

1.    Miscellaneous Specialty Drugs Oral = Yes w/ Prior Authorization

Healthcare Reform: Not applicable


West Virginia

Additional Restriction(s):


Drugs Products
  • Zytiga (abiraterone acetate)
FDA-Approved Indications:
  • Treatment of patients with metastatic castration-resistant prostate cancer (CRPC) in combination with prednisone.
  • Treatment of patients with metastatic high-risk castration-sensitive prostate cancer in combination with prednisone


Zytiga inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis. In clinical trials abiraterone acetate decreased serum testosterone and other androgens.  Androgen sensitive prostatic carcinoma responds to treatment that decreases androgen levels.

Approval Criteria

When a benefit, coverage of Zytiga may be approved when one of the following criterion is met (A. or B.):

A.    Zytiga is to be used in combination with prednisone for  members diagnosed with metastatic castration-resistant prostate cancer (ICD-9 185, ICD-10 C61)

B.    Zytiga is to be used in combination with prednisone for members diagnosed with metastatic high-risk castration-sensitive prostate cancer (ICD-9 185, ICD-10 C61)

I.        For Commercial and Healthcare Reform members enrolled in a Delaware plan, an exception to select criteria within this policy may be made based on Policy J-651 – Delaware—Cancer Chemotherapy Override Exception—Commercial and Healthcare Reform.

Limitations of Coverage

I.        Coverage of Zytiga for disease states outside its FDA-approved indications should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions.

II.        For Commercial or HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.

Authorization Duration
  • Commercial and HCR Plans: If approved, up to a lifetime authorization may be granted.

Automatic Approval Criteria


Version: J-726-001
Effective Date Begin: 05/14/2018
Effective End Begin: 08/19/2018
Original Date: 05/08/2001
Review Date: 05/02/2018


  1. Zytiga (abiraterone acetate) [package insert]. Janssen Biotech Inc. Horsham, PA. February 2018.
  2. Abiraterone acetate. Clinical Pharmacology. Tampa, FL: Gold Standard, Inc; 2012. Updated June 11, 2015.
  3. Abiraterone acetate. DRUGDEX System. New York: Thomson Reuters; December 2, 2016. 
  4. Gerald K. McEvoy, Pharm.D., ed. 2015. AHFS Drug Information® - 56th Ed. Bethesda, MD. American Society of Health-System Pharmacists. ISBN-10: 1-58528-380-0, ISBN-13: 978-1-58528-380-4. STAT!Ref Online Electronic Medical Library.
  5. Fizazi K, Tran N, Fein L, et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. NEJM. 2017. Doi: 10.1056/NEJMoa1704174.

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Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.

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