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Prior Authorization Protocol
CIALISR (tadalafil), VIAGRAR (sildenafil), LEVITRAR, STAXYNTM (vardenafil), STENDRATM (avanafil)

HNCA
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    Cialis, Viagra, Levitra, Staxyn, Stendra
    • Treatment of erectile dysfunction (ED)
    Cialis Only
    • Treatment of signs and symptoms of benign prostatic hyperplasia (BPH)
    • Treatment of ED and the signs and symptoms of BPH
  2. Health Net Approved Indications and Usage Guidelines:
    Benign Prostatic Hyperplasia (Cialis request only)
    • Patient is male
    AND
    • Patient is NOT on nitrates
    AND
    • Failure or clinically significant adverse effects to ONE alpha blocker (terazosin, doxazosin, tamsulosin, alfuzosin, RapafloR) AND ONE 5-alpha reductase inhibitor (finasteride or AvodartR)
    Erectile Dysfunction
    • Diagnosis of erectile dysfunction
    AND
    • Patient is male
    AND
    • Patient is NOT on nitrates
    AND
    • For EHB/IEX (Exchange) plans failure or clinically significant adverse effects to Staxyn
  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.
    • Patients taking nitrates e.g., NitrodurR, NitrobidR, NitrostatR, IsordilR, IsmoR
    • Members without sexual dysfunction coverage (for diagnosis of ED)
    • Daily dosing of Cialis 2.5 mg or 5 mg strengths for diagnosis of ED
  4. General Information:
    • PDE5 inhibitors should not be used in patients who have conditions that might predispose them to priapism, such as sickle cell anemia, multiple myeloma, or leukemia, or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease.
    • Cialis is not recommended for use in combination with alpha blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering.
    • For diagnosis of ED: for HNCA commercial members, the member's Evidence of Coverage states "These Prescription Drugs are covered for up to a number of doses or tablets specified in the Recommended Drug List."
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    doxazosin (CarduraR/Cardura XL)
    BPH
    Immediate Release
    1 mg PO QD,
    titrate to 2 mg QD and thereafter to
    4 mg QD and 8 mg QD
    Dosing range
    1 - 8 mg
    Extended Release
    4 mg PO QD
    Dosing range
    4 - 8 mg

    8 mg/day

    terazosin (HytrinR)
    BPH
    1 mg PO QD;
    increase the dose to 2 mg, 5 mg, or 10 mg QD
    in a stepwise fashion
    Dosing Range
    1 - 20 mg

    20 mg/day

    tamsulosin (FlomaxR)

    BPH
    0.4 - 0.8 mg PO QD

    0.8 mg/day

    alfuzosin (UroxatralR)

    BPH
    10 mg PO QD

    10 mg/day

    RapafloR (silodosin)

    BPH
    4 - 8 mg PO QD

    8 mg/day

    finasteride (ProscarR)*

    BPH
    5 mg PO QD

    5 mg/day

    AvodartR (dutasteride)*

    BPH
    0.5 mg PO QD

    0.5 mg/day

    JalynR (dutasteride/ tamsulosin)*

    BPH
    0.5/0.4 mg PO QD

    0.5/0.4 mg/day

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

    Viagra

    ED
    50 mg PO 1 hour (0.5-4 hours)
    before sexual activity.
    Dosing range
    25 -100 mg
    The maximum recommended dosing frequency is ONCE per day.

    Benefit Renewal Date
    (Quantity limits are plan specific)

    Cialis

    BPH
    2.5-5 mg PO QD
    (maximum 5 mg/day)
    ED
    Daily for ED
    2.5 - 5 mg PO QD*
    PRN for ED
    10 mg PO before sexual activity
    Dosing range
    5 - 20 mg.
    The maximum recommended dosing frequency is ONCE per day.
    *NOTE: daily therapy for ED is a benefit exclusion.
    Refer to the member's evidence of coverage for plan specific quantity limits.
    BPH
    Length of Benefit
    ED
    Benefit Renewal Date
    (Quantity limits are plan specific)

    Levitra

    ED
    10 mg PO 60 minutes before sexual activity.
    Dosing range:
    5 - 20 mg
    The maximum recommended dosing frequency is ONCE per day.
    Benefit Renewal Date
    (Quantity limits are plan specific)

    Staxyn

    ED
    Place 1 tablet (10 mg) on the tongue 60 minutes before sexual activity.
    The maximum recommended dosing frequency is ONCE per day.

    Benefit Renewal Date
    (Quantity limits are plan specific)


    Stendra

    ED
    100 mg PO 30 minutes before sexual activity.
    Dosing range:
    50 - 200 mg.
    The maximum recommended dosing frequency is ONCE per day.

    Benefit Renewal Date
    (Quantity limits are plan specific)

  7. Product Availability:
    Cialis Tablet: 2.5 mg, 5 mg, 10 mg, and 20 mg
    Viagra Tablet: 25 mg, 50 mg, and 100 mg
    Levitra Tablet: 2.5 mg, 5 mg, 10 mg, and 20 mg
    Staxyn ODT (not scored): 10 mg
    Stendra: 50 mg, 100 mg and 200 mg
  8. References:
    1. Cialis [packager insert]. Indianapolis, IN: Eli Lilly; April 2014.
    2. Viagra [package insert]. New York, NY: Pfizer, Inc.; March 2014.
    3. Levitra [package insert]. Wayne, NJ: Bayer Pharmaceuticals Corporation; Aprl 2014.
    4. Staxyn [package insert]. Wayne, NJ: Bayer Pharmaceuticals Corporation; April 2014.
    5. Stendra [package insert]. Mountain View, CA: Vivus; April 2014.
    6. Guay, AT, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Male Sexual Dysfunction: A Couples Problem-2003 Update. Endocrine Practice, 2003; 9(1): 77-95
    7. Lue TF. Drug therapy: Erectile dysfunction. N Engl J Med 2000;342:1802.
    8. Steele, D. Drugs causing sexual dysfunction and their alternatives: A Reference Tool. Urol Nurs. 1989 Oct-Dec;9(6):10-12.
    9. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 17, 2014.
    10. American Hospital Formulary Service Drug Information [Internet database]. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 17, 2014.
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.