Kerydin (tavaborole) — Blue Cross Blue Shield of Oklahoma

Initial criteria

• The patient has a diagnosis of onychomycosis (tinea unguium) AND
• 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
• Treatment of the patient’s onychomycosis is medically necessary and not entirely for cosmetic reasons AND
• The fungal nail infection is confirmed by laboratory testing (KOH preparation, fungal culture, periodic acid-Schiff [PAS] staining, or PCR testing) [lab results required] AND
• ONE of the following regarding oral antifungal therapy: (A) Patient has tried and had an inadequate response to ONE oral antifungal agent (itraconazole, terbinafine) OR (B) Patient has intolerance or hypersensitivity to ONE oral antifungal agent OR (C) Patient has an FDA labeled contraindication to ALL oral antifungal agents OR (D) Oral antifungal agents are not clinically appropriate AND
• If requested agent is ciclopirox 8% topical solution, treatment will include removal of the unattached infected nail(s) by a health care professional AND
• If requested agent is a brand agent, ONE of the following: (A) Patient is currently treated and stable on requested agent OR (B) Patient has tried and had inadequate response to ONE generic antifungal onychomycosis agent (itraconazole, terbinafine, ciclopirox) OR (C) ONE generic antifungal onychomycosis agent discontinued due to lack of efficacy/effectiveness/adverse event OR (D) Patient has intolerance/hypersensitivity to ONE generic antifungal onychomycosis agent OR (E) Patient has FDA labeled contraindication to ALL generic antifungal agents OR (F) ONE generic antifungal agent expected ineffective based on clinical characteristics or causes adherence barrier/adverse reaction/comorbid exacerbation OR (G) ONE generic antifungal agent not in best interest based on medical necessity OR (H) Patient tried another drug in same class or mechanism and discontinued due to lack of efficacy/effectiveness/adverse event [chart notes required] AND
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months