Pharmacy Policy Bulletin |
Zytiga and Yonsa (abiraterone acetate) - Commercial and Healthcare Reform | |
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Number: J-726 | Category: Prior Authorization |
Line(s) of Business:
Commercial |
Benefit(s):
Commercial: Prior Authorization (1.)
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: | 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:
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Approval Criteria |
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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 |
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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 |
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Automatic Approval Criteria |
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None |
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 |
References: