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Jublia (efinaconazole) — Blue Cross Blue Shield of Montana

onychomycosis (tinea unguium)

Preferred products

  • itraconazole
  • terbinafine
  • ciclopirox (generic)

Initial criteria

  • 1. Diagnosis of onychomycosis (tinea unguium) AND
  • 2. The patient has ONE of the following: diabetes mellitus, peripheral vascular insufficiency, or immune deficiency due to medical condition or treatment (e.g., cancer chemotherapy, HIV/AIDS, anti-rejection therapy post organ transplant) AND
  • 3. Treatment of the onychomycosis is medically necessary and not entirely for cosmetic reasons AND
  • 4. Fungal nail infection confirmed by laboratory testing (KOH preparation, fungal culture, PAS staining, or PCR testing) [lab results required] AND
  • 5. ONE of the following:
  • A. Tried and had an inadequate response to ONE oral antifungal agent (itraconazole, terbinafine) OR
  • B. Has intolerance or hypersensitivity to ONE oral antifungal agent OR
  • C. Has an FDA-labeled contraindication to ALL oral antifungal agents OR
  • D. Oral antifungal agents are not clinically appropriate AND
  • 6. If requested agent is ciclopirox 8% topical solution, treatment will include removal of unattached, infected nail(s) by a health care professional AND
  • 7. If requested agent is a brand agent, ONE of the following:
  • A. Currently being treated with requested agent and stable on it [chart notes required] OR
  • B. Tried and had an inadequate response to ONE generic antifungal onychomycosis agent (itraconazole, terbinafine, ciclopirox) [chart notes required] OR
  • C. ONE generic antifungal onychomycosis agent was discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR
  • D. Has intolerance or hypersensitivity to ONE generic antifungal onychomycosis agent [chart notes required] OR
  • E. Has an FDA labeled contraindication to ALL generic antifungal onychomycosis agents [chart notes required] OR
  • F. ONE generic antifungal onychomycosis agent is expected to be ineffective or contraindicated based on known clinical characteristics, adherence barriers, comorbid conditions, or risk of adverse events [chart notes required] OR
  • G. ONE generic antifungal onychomycosis agent is not in the best interest of the patient based on medical necessity [chart notes required] OR
  • H. Tried another prescription drug in same pharmacologic class or with same mechanism of action as ONE generic antifungal onychomycosis agent and it was discontinued due to lack of efficacy or adverse event [chart notes required] AND
  • 8. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months