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

onychomycosis (tinea unguium)

Preferred products

  • itraconazole capsules (generic)

Initial criteria

  • ONE of the following:
  • A. Diagnosis of onychomycosis (tinea unguium) AND ALL of the following:
  • 1. The requested agent is Sporanox (itraconazole) capsules AND
  • 2. The patient has not received treatment with the requested agent within the past 12 months AND
  • 3. 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) AND
  • 4. Treatment of onychomycosis is medically necessary and not entirely for cosmetic reasons AND
  • 5. Fungal nail infection is confirmed by laboratory testing (KOH preparation, fungal culture, PAS staining, or PCR testing) [lab results required] AND
  • 6. If the request is for a brand agent with an available generic equivalent (Sporanox capsules versus itraconazole capsules), then ONE of the following:
  • A. Patient has tried and had inadequate response to the generic equivalent [chart notes required] OR
  • B. The generic equivalent was discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR
  • C. The patient has intolerance or hypersensitivity to the generic equivalent not expected with brand [chart notes required] OR
  • D. The patient has an FDA labeled contraindication to the generic equivalent not expected with brand [chart notes required] OR
  • E. The generic equivalent is expected to be ineffective based on clinical characteristics or cause significant adherence barrier, worsen comorbid condition, or impair function [chart notes required] OR
  • F. The generic equivalent is not in the best interest of the patient based on medical necessity [chart notes required] OR
  • G. The patient has tried another prescription drug in the same pharmacologic class or mechanism and discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR
  • H. There is support for the use of the requested brand agent over the generic equivalent
  • B. The patient has another FDA labeled diagnosis for the requested agent and route OR
  • C. The patient has another indication supported in compendia for the requested agent and route AND
  • 2. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

BCBSIL and BCBSMT: 6 months; BCBSNM: 3 months; others: toenail infection 3 months, fingernail infection 5 weeks, oropharyngeal/esophageal candidiasis 6 weeks, other indications 12 months