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: |
Zytiga
Yonsa
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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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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) II. Yonsa A. Yonsa is to be used in combination with methylprednisolone for members diagnosed with metastatic castration-resistant prostate cancer
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Limitations of Coverage |
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I. Coverage of abiraterone acetate 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. |
Authorization Duration |
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Automatic Approval Criteria |
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None |
Version: J-726-002 |
Effective Date Begin: 08/20/2018 |
Effective End Begin: 08/08/2019 |
Original Date: 05/08/2001 |
Review Date: 08/20/2018 |
References: