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Prior Authorization Protocol
SPORANOXR, ONMELR (itraconazole)


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:
    Sporanox capsules
    • Treatment of the following fungal infections in immunocompromised and non-immunocompromised patients:
      • Blastomycosis, pulmonary and extrapulmonary
      • Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis
      • Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy
    • Treatment of the following fungal infections in non-immunocompromised patients:
      • Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium)
      • Onychomycosis of the fingernail due to dermatophytes (tinea unguium)
    Sporanox oral solution
    • Treatment of oropharyngeal and esophageal candidiasis
    Onmel tablets
    • For the treatment of onychomycosis of the toenail caused by Trichophyton rubrum or T. mentagrophytes
  2. Health Net Approved Indications and Usage Guidelines:
    Any one of the following diagnosis:
    • Blastomycosis (pulmonary or extrapulmonary)
    • Histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal disease)
    • Aspergillosis (pulmonary or extrapulmonary)
    • Coccidioidomycosis (primary pulmonary with increased risk for complications or dissemination or persistent symptoms of fatigue, malaise, or fever lasting beyond 3 weeks)
    • Sporotrichosis (cutaneous, lymphonodular)
    • Oropharyngeal and esophageal candidiasis
    • Tinea versicolor
      • Failure or clinically significant adverse effects to one of the following:
        • Oral fluconazole
        • Topical or oral ketoconazole
    • Tinea capitis
      • Failure of a 4-8 week trial or clinically significant adverse effects to terbinafine
    • Other Tinea infection e.g. Tinea pedis, Tinea corporis, Tinea cruris
      • Failure or clinically significant adverse effects to a minimum of two 2-week trials of TWO prescription strength topical antifungal agents

    • Diagnosis of onychomycosis (tinea unguium)
    AND
    • For Onmel requests, failure or clinically significant adverse effects to itraconazole capsules
  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)
    • More than one course of therapy per year for onychomycosis. Sporanox remains in the nail plate areas for 9 months. Full therapeutic effect is expected upon new nail growth.
  4. General Information:
    • Cardiac dysrrhythmias have occurred in patients using pimozide, triazolam, dofetilide, nisoldipine, oral midazolam, levacetylmethadol (levomethadyl), or quinidine with Sporanox. Sporanox may increase plasma concentrations of these CYP3A4 substrates, and lead to serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death. Concomitant use of these agents and Sporanox is contraindicated.
    • Due to the increased risk of skeletal muscle toxicity, including rhabdomyolysis, HMG CoA-reductase inhibitors are contraindicated with Sporanox. Increased plasma concentrations of atorvastatin, cerivastatin, lovastatin, and simvastatin have been observed in patients concurrently using Sporanox in clinical studies.
    • Ergot alkaloids metabolized by CYP3A4 such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) are contraindicated with Sporanox. Sporanox may increase plasma concentrations of ergot alkaloids and lead to ergotism, potentially leading to cerebral ischemia and/or ischemia of the extremities.
    • Sporanox is not FDA-approved, but has an A-II recommendation for the treatment of Sporotrichosis per Infectious Disease Society of America (IDSA). For cutaneous and lymphocutaneous sporotrichosis infections, response rates of 90%-100% were noted with itraconazole therapy, compared with a 63%-71% response rate associated with fluconazole therapy.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Econazole (SpectazoleR) 1% cream

    Tinea corporis or cruris
    Apply QD x 2 weeks
    Tinea pedis
    Apply QD x 4 weeks

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    ExeldermR
    (sulconazole) 1% cream, solution

    Tinea corporis or cruris
    Apply QD-BID x 3 weeks
    Tinea pedis
    Apply BID x 4 weeks

    This field intentionally left blank

    Ketoconazole (NizoralR) 2% cream

    Tinea corporis or cruris
    Apply QD x 2 weeks
    Tinea pedis
    Apply QD x 6 weeks

    This field intentionally left blank

    Ciclopirox (LoproxR) 0.77% cream

    Tinea corporis or cruris
    Apply BID x 4 weeks
    Tinea pedis
    Apply BID x 4 weeks

    This field intentionally left blank

    NaftinR (naftifine)1% cream, (gel)

    Tinea corporis or cruris
    Apply QD, (BID) x 2-4 weeks
    Tinea pedis
    Apply QD, (BID) x 4-6 weeks

    This field intentionally left blank

    OxistatR(oxiconazole nitrate) 1% cream, lotion

    Tinea corporis or cruris
    Apply QD-BID x 2 weeks
    Tinea pedis
    Apply QD-BID x 4 weeks

    This field intentionally left blank

    Ketoconazole (NizoralR) tablets

    Tinea versicolor
    400 mg PO once or
    200 mg PO QD x 5 days

    This field intentionally left blank

    Fluconazole (DiflucanR) tablets

    Tinea versicolor
    400 mg PO weekly x 2 weeks

    This field intentionally left blank

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

    Itraconazole (SporanoxR)

    Onychomycosis
    Toenails:
    Pulse: 200 mg PO BID x 1 week/month x 3 months
    Continuous: 200 mg PO QD x 3 months
    Fingernails:
    Pulse: 200 mg PO BID x 1 week/month x 2 months
    Blastomycosis; Nonmeningeal histoplasmosis
    200 mg PO QD - BID
    Aspergillosis
    200 mg PO QD - BID
    Oropharyngeal or esophageal candidiasis
    200 mg (20 ml) PO daily or 100 mg (10 ml) PO BID
    Tinea capitis
    3-5 mg/kg/day PO for 4-6 weeks
    Tinea pedis
    200 mg PO QD x 15 days
    Tinea cruris, corporis
    200 mg PO QD x 1-2 weeks
    Tinea versicolor
    200 mg PO QD x 7 days
    Sporotrichosis (cutaneous, lymphonodular)
    Loading dose of 200 mg PO q 8 hours x 3 days, followed by 200 mg PO QD or 200 mg PO BID for patients not responding; continue for 2 to 4 weeks after all lesions have healed
    Onychomycosis
    Toenails:
    1 pulse pack (28 caps) or 60 caps each month for 3 months (Authorization for onychomycosis is limited to one course of therapy per year. Only the pulsepak is approved for onychomycosis.)
    Fingernails:
    1 pulse pack (28 caps) each month for 2 months (Authorization for onychomycosis is limited to one course of therapy per year. Only the pulsepak is approved for onychomycosis.)
    Blastomycosis; Nonmeningeal histoplasmosis
    12 months (Extension beyond 12 months will be authorized if patients remained on therapy)
    Aspergillosis
    12 months (Extension beyond 12 months will be authorized if patients remained on therapy)
    Oropharyngeal or esophageal candidiasis
    14 days
    Tinea capitis
    1 month
    Tinea pedis
    15 days
    Tinea cruris, corporis
    14 days
    Tinea versicolor
    7 days
    Sporotrichosis (cutaneous, lymphonodular)
    4 weeks

    OnmelR

    Onychomycosis of Toenails:
    200 mg PO QD for 12 weeks

    12 weeks

  7. Product Availability:
    Sporanox Capsules 100 mg
    Sporanox Pulsepak: contains 28 of the 100 mg capsules
    Sporanox Oral solution: 10 mg/ml solution
    Onmel Tablets: 200 mg
  8. References:
    1. Sporanox [Prescribing information] Olen, Belgium: Janssen Pharmaceuticals; April 2012.
    2. Sporanox Solution [Prescribing information] Beerse, Belgium: Janssen Pharmaceutica N.V; June 2014.
    3. Onmel [Prescribing information] Greensboro, NC: Merz Pharmaceuticals LLC; November 2012.
    4. Gilbert D, Sande M, Moellering R, et al. Sanford Guide to Antimicrobial Therapy. 37th ed. Hyde Park, VT: Antimicrobial Therapy, Inc; 2007.
    5. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 30, 2015.
    6. Stevens DA, Kan VL, Judson MA, et al. IDSA Treatment Guidelines for Diseases Caused by Apergillus. Clinical Infectious Diseases. 2008;46:327360.
    7. Dermatophyte (tinea) Infections. In: UptoDate. [Internet database]. Waltham, MA: UptoDate, Inc. Updated periodically. Accessed June 30, 2015.
    8. Kauffman CA, Bustamante B, Chapman SW, et al: Clinical practice guidelines for the management of sporotrichosis: 2007 update by the Infectious Diseases Society of America. Clin Infect Dis 2007;45:1255-1265.

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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.