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.) 1. Miscellaneous Specialty Drugs Oral = Yes w/ Prior Authorization
Quantity Limits (1., 2., 3., or 4.): 1. Rx Mgmt Quantity Limits = Safety/ Specialty 2. Rx Mgmt Quantity Limits = Safety/Specialty + Dose Opt 3. Rx Mgmt Quantity Limits = Safety/Specialty + Dose Opt + Watchful 4. Quantity Limit = QPC = Yes 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: |
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.
Quantity Limits When a benefit, additional quantities of Zytiga 500 mg, up to 4 tablets per day, may be approved when the following criterion is met (A.): A. The member is taking a strong CYP3A4 inducer.
II. Yonsa When a benefit, coverage of Yonsa may be approved when all of the following criteria are met (A., B., and C.): A. Yonsa is to be used in combination with methylprednisolone. B. The member has been diagnosed with metastatic castration-resistant prostate cancer. C. Documentation that generic abiraterone acetate is ineffective or not tolerated.
Quantity Limits When a benefit, additional quantities of Yonsa 125 mg, up to 8 tablets per day, may be approved when the following criterion is met (A.): A. The member is taking a strong CYP3A4 inducer.
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.
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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.
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Authorization Duration |
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. Commercial and HCR Plans: If approved, up to a 24 month authorization may be granted. |
Automatic Approval Criteria |
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None |
Version: J-726-004 |
Effective Date Begin: 12/09/2019 |
Effective End Begin: 11/29/2020 |
Original Date: 05/08/2001 |
Review Date: 11/06/2019 |