WHA

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

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

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

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)
      OR
    • For continuation of prior therapy
Brand Zytiga

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)
      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-sensitive prostate cancer

  • Diagnosis of castration-sensitive prostate cancer
Brand Zytiga, 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

  • Guideline ID
    GL-143576

  • Formulary
    EHB

  • Effective date
    May 1, 2024

  • P&T approval date
    Jul 19, 2013

P & T Revisions

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

  1. Zytiga Prescribing Information. Janssen Biotech Inc. Horsham, PA. August 2021.
  2. 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.
  • 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