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Prior Authorization Protocol
CIALISR (tadalafil)

HNMC
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 (ED) [not covered, benefit exclusion]
    • 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:
    • Diagnosis of symptomatic BPH
    AND
    • Patient is NOT on nitrates and or guanylate cyclase stimulators (e.g., Adempas (riociguat))
    AND
    • Failure or clinically significant adverse effects to ONE alpha blocker (e.g., terazosin, doxazosin, tamsulosin) AND ONE 5-alpha reductase inhibitor (e.g., finasteride)
  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
    • Treatment of ED without concomitant BPH is a benefit exclusion
    • Patients taking nitrates e.g. NitrodurR, NitrobidR, NitrostatR, IsordilR, IsmoR
    • Patients taking guanylate cyclase stimulators (e.g., Adempas (riociguat))
  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.
    • Cialis is not recommended for use in combination with guanylate cyclase stimulators, such as Adempas (riociguat) as Cialis may potentiate the hypotensive effects of guanylate cyclase stimulators.
    • Cialis for once daily use is approved for BPH and should be used up to a maximum dose of 5 mg PO QD.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    doxazosin (CarduraR/ Cardura XL*)

    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)
    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)

    0.4 - 0.8 mg PO QD

    0.8 mg/day

    alfuzosin (UroxatralR)*

    10 mg PO QD

    10 mg/day

    RapafloR (silodosin)*

    4 - 8 mg PO QD

    8 mg/day

    finasteride (ProscarR)*

    5 mg PO QD

    5 mg/day

    dutasteride (AvodartR)*

    0.5 mg PO QD

    0.5 mg/day

    JalynR (dutasteride/ tamsulosin)*

    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

    Cialis

    2.5 - 5 mg PO QD

    Length of benefit

  7. Product Availability:
    Cialis Tablet: 2.5 mg, 5 mg (10 mg and 20 mg tablets are a benefit exclusion)
  8. References:
    1. Cialis [package insert]. Indianapolis, IN: Eli Lilly; September 2015.
    2. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 09, 2015.
    3. American Hospital Formulary Service Drug Information [Internet database]. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 09, 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.