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Prior Authorization Protocol
XTANDIR (enzalutamide)

NATL

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

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:
    • Treatment of patients with metastatic castration-resistant prostate cancer
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of metastatic castration-resistant prostate cancer
    AND
    • For patients without visceral metastases: Failure or clinically significant adverse effects to Zytiga
  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

    docetaxel (Taxotere) * + prednisone

    Taxotere 75 mg/m2 IV every 3 weeks (with prednisone 10 mg per day)

    docetaxel 75 mg/m2 IV every 3 weeks (with prednisone 10 mg/day)

    Zytiga(abiraterone) * + prednisone

    1000 mg PO QD in combination with prednisone 10 mg per day

    1000 mg/day (with prednisone 10mg/day)

    Xofigo (radium Ra 223 dichloride) *

    50 kBq/kg (1.35 microcurie/kg)IV every 4 weeks for 6 cycles

    50 kBq/kg per dose
    6 doses/24 weeks

    Provenge (sipuleucel-T) *

    One dose IV approximately every 2 weeks for 3 doses
    Each dose contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, in 250 ml of Lactated Ringer's Injection

    3 doses/6 weeks

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

    Xtandi

    160 mg (four 40 mg capsules) PO QD with or without food.

    Length of Benefit

    Treatment continues until no longer clinically beneficial or until unacceptable toxicity occurs.

  7. Product Availability:
    Capsule: 40 mg
  8. References:
    1. Xtandi[ Prescribing information] Northbrook, IL: Astellas Pharma US, Inc.; September 2014.
    2. Enzalutamide. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 28, 2015.
    3. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. June 28, 2015.
    4. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com. Accessed June 28, 2015.
    5. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 25, 2015.
    6. National Comprehensive Cancer Network. Prostate Cancer Version 1.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed June 28, 2015.
    7. Beer TM, Armstrong AJ, Rathkopf DE et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 2014; 371(5):424-433.
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.
Draft Prepared: 17-SEP-12 RG
Approved By Health Net National P&T: 14-NOV-12, 20-FEB-13, 22-MAY-13, 20-NOV-13, 19-NOV-14, 18-FEB-15, 18-NOV-15
Revised: 14-MAR-13 AM, 01-JUL-14 TJ, 22-SEP-14 RG, 14-OCT-14 RO, 16-JAN-15 RG, 03-MAR-15 RG, 03-JUL-15 MV