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

Healthcare Reform



Prior Authorization (1.)

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


Healthcare Reform: Not applicable


West Virginia

Additional Restriction(s):


Drugs Products
  • Zytiga (abiraterone acetate)
  • Yonsa (abiraterone acetate micronized)
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


  • Treatment of patients with metastatic castration-resistant prostate cancer (CRPC) in combination with methylprednisolone.


Abiraterone 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.

Prescribing Considerations:

  • Yonsa tablets may have different dosing and food effects than other abiraterone acetate products.

Approval Criteria

I.      Zytiga

When a benefit, coverage of Zytiga may be approved when one of the following criteria are met (A. and B.):

A.    Zytiga is used in combination with prednisone and the following

1.     The member has a diagnosis of castration-resistant prostate cancer

2.     The member has a diagnosis of metastatic high-risk castration-sensitive prostate cancer.

B.    Documentation that generic abiraterone acetate is ineffective or not tolerated (Commercial only)


II.    Yonsa

When a benefit, coverage of Yonsa may be approved when the following criteria are met (A. and B.):

A.    Yonsa is to be used in combination with methylprednisolone

B.    The member has been diagnosed with metastatic castration-resistant prostate cancer



III.        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 abiraterone acetate for disease states outside of the FDA-approved indications should be denied based on the lack of clinical data to support effectiveness and safety in other conditions.

II.        For Commercial or HCR members with a closed formulary, a non-formulary product will be approved only 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 24 month authorization may be granted.

Automatic Approval Criteria


Version: J-726-003
Effective Date Begin: 08/09/2019
Effective End Begin: 12/08/2019
Original Date: 05/08/2001
Review Date: 08/07/2019


  1. Zytiga [package insert]. Horsham, Pennsylvania: Janssen Biotech Inc.; September 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, ed. 2015. AHFS Drug Information® - 56th Ed. Bethesda, MD. American Society of Health-System Pharmacists. 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.
  6. Yonsa [package insert]. Cranbury, New Jersey: Sun Pharmaceutical Industries, Inc.; May 2018.

View Previous Versions

[Version 002 of J-726]
[Version 001 of J-726]

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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