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Prior Authorization Protocol

CAVERJECTR, EDEXR (alprostadil)

NATL

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 erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology
  2. Health Net Approved Indications and Usage Guidelines:
    • Erectile dysfunction
      • Patient is male

    AND

      • Failure or clinically significant adverse effects to ONE oral Phosphodiesterase Type 5 (PDE5) inhibitor (e.g., CialisR) unless contraindicated (e.g., concomitant nitrate use)
    • Orphan designated indication
      • Patient has severe peripheral arterial occlusive disease (critical limb ischemia) and other procedures, grafts or angioplasty are not indicated
    • Off-label indications
      • Patient has peripheral vascular disease and a limb(s), finger(s), or toe(s) is severely ischemic, gangrenous or loss of a limb or digit is possible
        OR
      • Patient has a non-healing digital ulcer related to Raynaud's disease or severe peripheral arterial occlusive disease, where amputation would otherwise be unavoidable
  3. Coverage is Not Authorized For:
    • Members without sexual dysfunction coverage
    • 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:
    • Intrancavernosal alprostadil should not be used in patients who have conditions that might predispose them to priapism, such as sickle cell anemia or trait, multiple myeloma, or leukemia, or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease. Patients with penile implants should not be treated with alprostadil.
    • In 1993, IV Alprostadil was approved under the FDA Orphan Drug designation for the "treatment of severe peripheral arterial occlusive disease (critical limb ischemia) in patients where other procedures, grafts or angioplasty, are not indicated". For additional information, refer to http://www.fda.gov/ohrms/dockets/dailys/00/mar00/030100/lst0094.pdf.
    • Peripheral vascular disease and Raynaud`s phenomenon both have Class IIb recommendations for use in Micromedex.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    CialisR (tadalafil)*

    Erectile Dysfunction
    Daily:
    2.5 - 5 mg PO QD (not covered)
    PRN:
    10 mg PO before sexual activity
    Dosing range:
    5 mg - 20 mg.

    The maximum recommended
    dosing frequency is ONCE per day.
    QD dosing:
    (5 mg/day)
    PRN dosing:
    (20 mg/day)
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Caverject

    Erectile Dysfunction
    Initial dosage titration should be
    done in the physician's office.

    Dosage range:
    1.25 mcg - 60 mcg intracavernosally
    prior to sexual activity.

    The recommended frequency of injection
    is no more than 3 times weekly,
    with at least 24 hours between each dose.

    6 months

    Quantity limits are plan specific

    Edex

    Erectile Dysfunction
    Initial dosage titration should be
    done in the physician's office.

    Dosage range:
    1- 40 mcg intracavernosally
    prior to sexual activity.

    The recommended frequency of injection
    is no more than 3 times weekly,
    with at least 24 hours between each dose.

    6 months

    Quantity limits may be plan specific

    Caverject/Edex

    Peripheral Vascular Disease
    Studies used doses of 1 to 4 nanograms/kg/min intravenously for up to 12 days
    Raynaud`s Phenomenon
    Studies used doses of 6 to 10 nanograms/kg/min intravenously for 12 to 72 hours

    Length of benefit

  7. Product Availability:
    Caverject vials lyophilized powder: 20 mcg, 40 mcg
    Caverject Impulse syringe kits: 10 mcg, 20 mcg
    Edex kits (w/ diluent): 10 mcg, 20 mcg, 40 mcg
  8. References:
    1. Caverject [Prescribing Information] New York, NY: Pharmacia and Upjohn; June 2014.
    2. Caverject Impulse [Prescribing Information] New York, NY: Pharmacia and Upjohn; December 2013
    3. Edex [package insert]. Smyrna, GA: Schwarz Pharma; January 2011.
    4. MicromedexR Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed June 3, 2015.
    5. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/default.aspx. Accessed June 3, 2015.
    6. Caverject. American Hospital Formulary Service Drug Information. Available at https://medicinescomplete.com/mc/ahfs/current/. Accessed June 3, 2015.
    7. Caverject Impulse. American Hospital Formulary Service Drug Information. Available at https://medicinescomplete.com/mc/ahfs/current/. Accessed June 3, 2015.
    8. Edex. American Hospital Formulary Service Drug Information. Available at https://medicinescomplete.com/mc/ahfs/current/. Accessed June 3, 2015.
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.