Jublia (efinaconazole) — Blue Cross Blue Shield of Illinois

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) [lab results are required] 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 the patient is currently stable on the requested agent [chart notes are required] OR B. The patient has tried and had an inadequate response to ONE generic antifungal onychomycosis agent (itraconazole, terbinafine, ciclopirox) [chart notes are required] OR C. ONE generic antifungal onychomycosis agent (itraconazole, terbinafine, ciclopirox) was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required] OR D. The patient has an intolerance or hypersensitivity to ONE generic antifungal onychomycosis agent [chart notes are required] OR E. The patient has an FDA labeled contraindication to ALL generic antifungal onychomycosis agents [chart notes are required] OR F. ONE generic antifungal onychomycosis agent (itraconazole, terbinafine, ciclopirox) is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm [chart notes are required] OR G. ONE generic antifungal onychomycosis agent is not in the best interest of the patient based on medical necessity [chart notes are required] OR H. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as ONE generic antifungal onychomycosis agent and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required] AND
• 8. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months