Diagnosis: Tinea Unguium.
Treatment: Jublia.

The insurer denied: Formulary exception for Jublia.
The denial is upheld.

The patient is an adult female with tinea unguium for whom Jublia 10% topical solution is requested. She has failed topical ciclopirox. Due to high cholesterol, she takes lipid-lowering medications and cannot take oral antifungals. Her PCP (primary care provider) will not allow cessation of the lipid-lowering agents for any period of time. She takes rosuvastatin.

The health plan should not cover the Formulary exception for Jublia.

Oral antifungals have superior efficacy to topical antifungals for the treatment of tinea unguium. Rosuvastatin has no interaction with terbinafine, one of the health plan's formulary alternatives, so there is no documented reason to avoid use of terbinafine. On the other hand, itraconazole and rosuvastatin have a possible interaction (combo may increase rosuvastatin levels, risk of myopathy, rhabdomyolysis, and other adverse effects) and should not be combined. Per the CDC (Centers for Disease Control and Prevention), oral antifungal therapy (terbinafine) is considered first-line treatment for confirmed onychomycosis. According to a Cochrane review, medication taken orally is evidenced to cure the condition more quickly and effectively than topical treatment. There was high-quality evidence that oral azole (itraconazole) and terbinafine treatments were more effective for achieving mycological cure and clinical cure for onychomycosis compared to placebo, and when compared directly, terbinafine was probably more effective than azoles and likely not associated with excess adverse events (griseofulvin was associated with more adverse reactions than azoles and terbinafine). Oral treatment of onychomycosis is the standard of care however, drug interactions and risk of acute liver injury can limit their use. Difficulties in formulating topical treatment to penetrate the nail and reach the site of infection in the nail bed has hampered the development and the use of topical agents Jublia (efinaconazole) is the first triazole antifungal developed for the treatment of onychomycosis. In 2 randomized trials, complete cure rate, defined as no evidence of fungal infection at week 52, was demonstrated in 15.2% to 17.8% of patients receiving efinaconazole (N=1236) compared with 3.3% to 5.5% receiving placebo (N=415) for the treatment of onychomycosis of the toenail. The odds of mycological cure with continuous terbinafine 250 mg (milligrams) are significantly greater than topical treatments. Therefore, given the above, the health plan should not cover the formula exception for Jublia.