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Jublia — Blue Cross Blue Shield of Texas

onychomycosis (tinea unguium)

Preferred products

  • itraconazole
  • terbinafine
  • ciclopirox

Initial criteria

  • 1. The patient has a diagnosis of onychomycosis (tinea unguium) AND
  • 2. 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
  • 3. Treatment of the patient’s onychomycosis is medically necessary and not entirely for cosmetic reasons AND
  • 4. The fungal nail infection is confirmed by laboratory testing (KOH preparation, fungal culture, periodic acid-Schiff [PAS] staining, or polymerase chain reaction [PCR] testing) AND
  • 5. ONE of the following: (A) The patient has tried and had an inadequate response to ONE oral antifungal agent (itraconazole, terbinafine) OR (B) The patient has an intolerance or hypersensitivity to ONE oral antifungal agent OR (C) The patient has an FDA labeled contraindication to ALL oral antifungal agents OR (D) The oral antifungal agents are not clinically appropriate AND
  • 6. If the requested agent is ciclopirox 8% topical solution, treatment will include removal of the unattached, infected nail(s) by a health care professional AND
  • 7. If the requested agent is a brand agent, ONE of the following: (A) The patient is currently being treated with the requested agent and is stable on it OR (B) The patient has tried and had an inadequate response to ONE generic antifungal onychomycosis agent (itraconazole, terbinafine, ciclopirox) OR (C) ONE generic antifungal onychomycosis agent was discontinued due to lack of efficacy, diminished effect, or adverse event OR (D) The patient has intolerance or hypersensitivity to ONE generic antifungal onychomycosis agent OR (E) The patient has FDA labeled contraindication to ALL generic antifungal onychomycosis agents OR (F) ONE generic antifungal onychomycosis agent is expected to be ineffective or cause significant barrier or harm OR (G) ONE generic antifungal onychomycosis agent is not in best interest of patient based on medical necessity OR (H) The patient has tried another prescription drug in same pharmacologic class or with same mechanism of action and it was discontinued due to lack of efficacy or adverse event AND
  • 8. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months