Jublia (efinaconazole) — Blue Cross Blue Shield of New Mexico
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 OR 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 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 required] OR (B) The patient has 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, diminished effect, or an adverse event [chart notes required] OR (D) The patient has an intolerance or hypersensitivity to ONE generic antifungal onychomycosis agent [chart notes required] OR (E) The patient 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 based on patient or drug characteristics; OR cause adherence barrier; OR worsen comorbid condition; OR decrease functional ability; OR cause an adverse reaction or harm [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) The patient has tried another prescription drug in the same pharmacologic class or mechanism as ONE generic antifungal onychomycosis agent and 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