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Sporanox (itraconazole) capsules — Blue Cross Blue Shield of Montana

onychomycosis (tinea unguium)

Preferred products

  • itraconazole capsules (generic)

Initial criteria

  • The patient has a diagnosis of onychomycosis (tinea unguium)
  • The requested agent is Sporanox (itraconazole) capsules
  • The patient has not received treatment for onychomycosis with the requested agent within the past 12 months
  • The patient has ONE of the following: diabetes mellitus, peripheral vascular insufficiency, immune deficiency due to medical condition or treatment (e.g., cancer chemotherapy, HIV/AIDS, anti-rejection therapy post organ transplant)
  • Treatment of the patient’s onychomycosis is medically necessary and not entirely for cosmetic reasons
  • Fungal nail infection is confirmed by laboratory testing (KOH preparation, fungal culture, PAS staining, or PCR testing) [lab results required]
  • If the request is for a brand agent with an available generic equivalent, ONE of the following:
  • - The patient has tried and had an inadequate response to the generic equivalent [chart notes required]
  • - The generic equivalent was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required]
  • - The patient has an intolerance or hypersensitivity to the generic equivalent that is not expected to occur with the brand agent [chart notes required]
  • - The patient has an FDA labeled contraindication to the generic equivalent not expected to occur with the brand agent [chart notes required]
  • - The generic equivalent is expected to be ineffective or cause a significant barrier to adherence, worsen comorbidity, or decrease functional ability [chart notes required]
  • - The generic equivalent is not in the best interest of the patient based on medical necessity [chart notes required]
  • - The patient has tried another prescription drug in the same class or mechanism of action and that drug was discontinued due to lack of efficacy or adverse event [chart notes required]
  • - There is support for use of the requested brand agent over the generic equivalent
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

3 months (toenail infection) or 5 weeks (fingernail infection); target agents limited to one approval per 12 months