Abiraterone acetate products - 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
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 defined as no more than a 45-day gap in therapy
Brand Zytiga
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Castration-resistant prostate cancer
- Submission of medical records (e.g., chart notes) confirming 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
- Both of the following:
- 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 AND
- Patient does not show evidence of progressive disease while on therapy
- Both of the following:
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic abiraterone acetate that has the same active ingredient AND
- Submission of medical records (e.g., chart notes) confirming generic abiraterone acetate has not been effective AND valid clinical justification provided explaining how Brand Zytiga is expected to provide benefit when generic abiraterone acetate has not been shown to be effective despite having the same active ingredient
Brand Abirtega, 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
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 defined as no more than a 45-day gap in therapy
Brand Zytiga
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Castration-sensitive prostate cancer
- Submission of medical records (e.g., chart notes) confirming 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)
- Both of the following:
- 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 AND
- Patient does not show evidence of progressive disease while on therapy
- Both of the following:
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic abiraterone acetate that has the same active ingredient AND
- Submission of medical records (e.g., chart notes) confirming generic abiraterone acetate has not been effective AND valid clinical justification provided explaining how Brand Zytiga is expected to provide benefit when generic abiraterone acetate has not been shown to be effective despite having the same active ingredient
Brand Abirtega, 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
2026-03-04, 2025-12-18, 2025-12-18, 2025-07-29, 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.5.2026. Available by subscription at: http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf. Accessed February 27, 2026.
- Abirtega Prescribing Information. Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ. Februrary 2025.
Revision History
- 2026-03-04: 2026 Annual Review - updated guideline
- 2025-12-18: No criteria change, bulk copy oRX-EHB
- 2025-12-18: no criteria changes, added IL statute operational note
- 2025-07-29: Move Abirtega to mirror generic.
- 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