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Prior Authorization Protocol
JUBLIAR (eficanozole), KERYDINTM (tavaborole)


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:
    • For the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of onychomycosis of the toenails
    AND
    • Failure or clinically significant adverse effects to terbinafine tablets
  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
    • Onychomycosis for HNOR Commercial members (onychomycosis treatment is a benefit exclusion).
  4. General Information:
    • Candida species cause up to 20% of onychomycosis. Jublia was found to be active against Candida species.
    • In clinical trials, patients received treatment with Jublia for a total of 48 weeks. The Complete Cure rate was assessed at Week 52 (4 weeks after completion of therapy).
    • In clinical trials, patients received treatment with Kerydin for 48 weeks. The Complete Cure rate was assessed at Week 52 (4 weeks after completion of therapy).
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    ciclopirox topical solution, 8%

    Apply topically QD x 48 weeks

    once daily

    itraconazole (SporanoxR,Onmel)*

    200 mg PO QD x 12 weeks
    or
    200 mg PO BID x 1 week/month x 12 weeks
    200 - 400 mg/day

    terbinafine (LamisilR)*

    250 mg PO QD x12 weeks250 mg/day
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Jublia

    Apply topically to affected toenails QD for 48 weeks

    48 weeks

    Kerydin

    Apply topically to affected toenails QD for 48 weeks

    48 weeks

  7. Product Availability:
    Jublia 10% topical solution: 4 mL, 8 mL
    Kerydin 5% topical solution: 4 mL,10 mL
  8. References:
    1. Jublia [Prescribing Information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; February 2015.
    2. Kerydin [Prescribing Information]. Palo Alto, CA: Anacor Pharmaceuticals Inc; July 2014.
    3. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. 2001;63:663-672.
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.