Zytiga (abiraterone acetate) - PA, NF
Indications for Prior Authorization
Zytiga (abiraterone acetate)
-
For diagnosis of Metastatic castration-resistant prostate cancer (mCRPC)
Indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) in combination with prednisone. -
For diagnosis of Metastatic castration-sensitive prostate cancer (mCSPC)
Indicated for the treatment of patients with metastatic high risk castration-sensitive prostate cancer (mCSPC) in combination with prednisone.
Criteria
Brand Zytiga, Brand Abirtega
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Castration-resistant prostate cancer
- Diagnosis of castration resistant (chemical or surgical) prostate cancer [2] AND
- One of the following:
- Trial and failure, contraindication, or intolerance to Xtandi (enzalutamide) OR
- For continuation of prior therapy
Brand Zytiga, Brand Abirtega
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Castration-resistant prostate cancer
- Diagnosis of castration resistant (chemical or surgical) prostate cancer [2] AND
- One of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Xtandi (enzalutamide) OR
- Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy
Generic abiraterone acetate
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Castration-resistant prostate cancer
- Diagnosis of castration resistant (chemical or surgical) prostate cancer [2]
Brand Zytiga, Brand Abirtega
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Castration-sensitive prostate cancer
- Diagnosis of castration-sensitive prostate cancer AND
- One of the following:
- Trial and failure, contraindication, or intolerance to one of the following:
- Xtandi (enzalutamide)
- Erleada (apalutamide)
- For continuation of prior therapy
Brand Zytiga, Brand Abirtega
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Castration-sensitive prostate cancer
- Diagnosis of castration-sensitive prostate cancer AND
- One of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to one of the following:
- Xtandi (enzalutamide)
- Erleada (apalutamide)
- Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy
Generic abiraterone acetate
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Castration-sensitive prostate cancer
- Diagnosis of castration-sensitive prostate cancer
Brand Zytiga, Brand Abirtega, Generic abiraterone acetate,
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Castration-sensitive prostate cancer, castration-resistant prostate cancer
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2025-05-30, 2025-05-07, 2025-03-05, 2024-03-14, 2023-07-11, 2023-05-01, 2022-03-03, 2021-12-17, 2021-11-01, 2021-09-28, 2021-05-26, 2021-05-25, 2021-02-22, 2021-02-03, 2020-02-12
References
- Zytiga Prescribing Information. Janssen Biotech Inc. Horsham, PA. November 2024.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Prostate Cancer. v.4.2018. Available by subscription at: http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf. Accessed September 18, 2018.
Revision History
- 2025-05-30: Correct spelling of Abirtega in criteria.
- 2025-05-07: Attach Abirtega to guideline, mirroring brand criteria.
- 2025-03-05: 2025 Annual Review - no changes
- 2024-03-14: 2024 Annual Review - no changes
- 2023-07-11: Removed specialist requirement
- 2023-05-01: Program update to remove requirement that drug must be used in combination with prednisone
- 2022-03-03: 2022 Annual Review. Updated references
- 2021-12-17: Program update to add non-formulary criteria for brand Zytiga.
- 2021-11-01: Program update to add Erleada as an addition trial and failure option for diagnosis of castration sensitive prostrate cancer (formulary strategy).
- 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
- 2021-02-22: 2021 Annual Review: no changes
- 2021-02-03: New generic for the 500mg.
- 2020-02-12: revised criteria
HEALTHY LIVING