ZYTIGA (abiraterone acetate)

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.