HN Logo
Prior Authorization Protocol
ZYTIGATM (abiraterone)

HNCA
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of metastatic, castration-resistant prostate cancer
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Metastatic prostate cancer is defined as cancer that has spread, or metastasized, to the lymph nodes or other parts of the body.
    • Castration-resistant prostate cancer is defined as cancer that has continued to grow despite the suppression of testosterone below castrate levels, either by surgical or pharmacologic means.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    EmcytR (estramustine)

    10-14 mg/kg PO daily in 3 or 4 divided doses

    16 mg/kg/day

    JevtanaR (cabazitaxel)* + prednisone

    25 mg/m2 IV every 3 weeks + prednisone 10 mg/day

    25 mg/m2 IV every 3 weeks + prednisone 10 mg/day

    Ketoconazole (NizoralR)

    200-400 mg PO every 8 hours

    400 mg PO every 8 hours

    mitoxantrone (NovatroneR) + prednisone

    Novantrone 12 mg/m2 IV every 3 weeks + prednisone 10 mg/day

    Novantrone 14 mg/m2 IV every 3 weeks + prednisone 10 mg/day

    docetaxel (TaxotereR) + prednisone

    Taxotere 75 mg/m2 IV every 3 weeks + prednisone 10 mg/day

    Taxotere 75 mg/m2 IV every 3 weeks + prednisone 10 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Zytiga

    1000 mg PO once daily in combination with prednisone 10 mg per day

    Length of Benefit

  7. Product Availability:
    Tablet: 250 mg
  8. References:
    1. Zytiga. Prescribing information, Janssen Biotech, Inc. December 2012.
    2. De Bono JS, et al. Abiraterone and increased survival in metastatic prostate cancer. NEJM. 2011;364(21):1995-2005.
    3. Ryan CJ, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 2013;368:138-148.
    4. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed July 19, 2013.
    5. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 19, 2013.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.