ZYTIGA (abiraterone acetate)

Self-Administration – oral

Diagnosis considered for coverage:
  • Indicated in combination with prednisone for the treatment of patients with:
    • Metastatic castration-resistant prostate cancer (CRPC)
    • Metastatic high-risk castration-sensitive prostate cancer (CSPC)
Coverage Criteria:

For diagnosis of metastatic castration resistant (chemical or surgical) or recurrent prostate cancer (CRPC):

  • Dose does not exceed 1,000 mg (two 500 mg tablets or four 250 mg tablets) once daily; AND
  • Patient has a diagnosis of metastatic castration resistant (chemical or surgical) or recurrent prostate cancer (CRPC); AND
  • Prescribed by or in consultation with an oncologist or urologist; AND
  • Zytiga will be used in combination with prednisone; AND
  • In those who have not had bilateral orchiectomy: Zytiga will be used concomitantly with a GnRH analog (e.g., Lupron [leuprolide], Zoladex [goserelin], Trelstar [triptorelin], Vantas [histrelin], Firmagon [degarelix]); AND
  • For requests for brand Zytiga only: 
    • Trial and failure, contraindication, or intolerance to Xtandi (enzalutamide); AND
    • Trial and failure, contraindication, or intolerance to generic abiraterone

For diagnosis of metastatic high-risk castration-sensitive prostate cancer (CSPC):

  • Dose does not exceed 1,000 mg (two 500 mg tablets or four 250 mg tablets) once daily; AND
  • Patient has a diagnosis of metastatic high-risk castration-sensitive prostate cancer (CSPC); AND
  • Prescribed by or in consultation with an oncologist or urologist; AND
  • Zytiga will be used in combination with prednisone; AND
  • In those who have not had bilateral orchiectomy: Zytiga will be used concomitantly with a GnRH analog (e.g., Lupron [leuprolide], Zoladex [goserelin], Trelstar [triptorelin], Vantas [histrelin], Firmagon [degarelix]); AND
  • For requests for brand Zytiga only: 
    • Trial and failure, contraindication, or intolerance to one of the following:
      • Xtandi (enzalutamide) 
      • Erleada (apalutamide); AND
    • Trial and failure, contraindication, or intolerance to generic abiraterone
Reauthorization Criteria:

For diagnosis of CRPC or CSPC prostate cancer:

  • Dose does not exceed 1,000 mg (two 500 mg tablets or four 250 mg tablets) once daily; AND
  • Patient does not show evidence of progressive disease while on therapy
Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • Recommended dose:
    • Metastatic CRPC: 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily
    • Metastatic High-risk CSPC: 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg administered orally once daily
  • Patients receiving Zytiga should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy
  • Zytiga is available as a 500 mg film-coated tablet and 250 mg uncoated tablet
  • Do not use Zytiga in patients with baseline severe hepatic impairment (Child-Pugh Class C)
  • Avoid concomitant strong CYP3A4 inducers during Zytiga treatment. If a strong CYP3A4 inducer must be co-administered, increase the Zytiga dosing frequency
  • Avoid co-administration of Zytiga with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate
  • NCCN Recommended Uses (off-label):
    • Localized (N0, M0) disease (very high risk prostate cancer only)
    • Regional (N1, M0) disease
    • Refer to NCCN Prostate Cancer guidelines for further guidance
Policy Updates:
  • 6/1/2023 – New policy approved by P&T
References:
  • Zytiga Prescribing Information. Janssen Biotech Inc. Horsham, PA. August 2021. 
  • 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.

 

Last review date: June 1, 2023

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