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Prior Authorization Protocol
LAMISILR (terbinafine) granules


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 tinea capitis in patients 4 years of age and older
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of Tinea capitis
  3. Coverage is Not Authorized For:
    • Treatment of Tinea (pityriasis) versicolor
    • 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:
    • Controlled clinical trials have not shown oral Lamisil tablets to be effective for the treatment of tinea (pityriasis) versicolor
    • Only the Lamisil granules, not the tablet formulation, are FDA approved for tinea capitis. The European Society for Pediatric Dermatology issued a Grade A recommendation (strength of evidence Ia) for terbinafine, itraconazole, or fluconazole tablets for tinea capitis in children caused by Trichophyton species since efficacy rates and potential adverse effects are similar to those of griseofulvin while requiring a shorter duration of treatment.
    • There is some evidence that a longer duration of treatment (e.g., 68 weeks) or higher dosage may be necessary when tinea capitis is caused by Microsporum canis.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    tolnaftate (various brands) 1% cream, soln, powder, spray powder/liquid

    Apply to affected area BID for 2-4 weeks.

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    griseofulvin microsize tablets (Grifulvin VR)

    Adults:
    500 mg PO QD or in divided doses for 4-6 weeks

    Children:
    10-20 mg/kg PO QD for 4-6 weeks

    1000 mg/day

    itraconazole (SporanoxR)*

    3-5 mg/kg PO QD for 4-6 weeks
    (non FDA approved)

    5 mg/kg/day

    griseofulvin ultramicrosize tablets (Gris-PEGR)

    Adults:
    300 mg - 375 mg PO QD or in divided doses for 4-6 weeks
    Children:
    5 - 15 mg/kg PO QD for 4 - 6 weeks

    Gris-PEG is only FDA indicated for children > 2yrs

    750 mg/day

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

    Lamisil (terbinafine granules)

    <25 kg patient: 125 mg PO QD
    25-35 kg patient: 187.5 mg PO QD
    >35 kg patient: 250 mg PO QD

    6 weeks

  7. Product Availability:
    Granules (Packet): 125, 187.5 mg
  8. References:
    1. Lamisil granules [Prescribing Information]. East Hanover, NJ: Novartis; February 2015.
    2. Kakourou T, Uksal U, European Society for Pediatric Dermatology. Guidelines for the management of tinea capitis in children. Pediatr Dermatol 2010;27:226.
    3. Sanford JP. The Sanford Guide to Antimicrobial Therapy. 41st edition. Sperryville, VA: Antimicrobial Therapy, Inc; 2011.
    4. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 01, 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.