Pharmacy Policy Bulletin |
Zytiga (abiraterone acetate) - Commercial and Healthcare Reform | |
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Number: J-726 | Category: Prior Authorization |
Line(s) of Business:
Commercial |
Benefit(s):
Commercial (1.): 1. Miscellaneous Specialty Drugs Oral = Yes w/ Prior Authorization Healthcare Reform: Not applicable |
Region(s):
All |
Additional Restriction(s):
None |
Drugs Products |
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FDA-Approved Indications: |
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Background: | 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 |
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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 |
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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 |
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Automatic Approval Criteria |
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None |
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 |
References: