On Tuesday, June 1st, the Food and Drug Administration on Tuesday approved a new new antifungal drug, Brexafemme (ibrexafungerp), to treat vulvovaginal candidiasis in adult females and pediatric females who have begun menstruating.
The one-day medication is the first non-azole oral treatment for vaginal yeast infection, and marks the first approved drug in a new antifungal class (triterpenoid) in more than 20 years.
The product’s sponsor, Scynexis, says Brexafemme will launch in the second half of 2021. The future looks bright for Brexafemme, as it has been granted a Qualified Infectious Disease Product designation by the FDA. This could lead to 10 years of marketing exclusivity in the U.S. Further, Scynexis is in the process of clinically testing the active ingredient in Brexafemme, ibrexafungerp, as an agent to prevent recurring vaginal yeast infections and to treat life-threatening, invasive fungal infections.
Still, if Scynexis expects to list a Brexafemme treatment regimen for between $350 and $450, as has been reported, it may face considerable uptake hurdles, particularly since its chief competitor, fluconazole, is approximately 10 times cheaper and currently maintains 90% of the market.
Fungal overgrowth can occur when there is a disruption to the pH balance or good bacteria in the vagina. This can be due, for example, to antibiotic use and high estrogen levels as a result of pregnancy and birth control.
The treatment options available to women, include an existing standard of care oral medication, Diflucan (fluconazole), which has been on the market for decades. Fluconazole inhibits the growth of yeast by decreasing the production of ergosterol. And, there’s a topical ointment called Monistat (miconazole), which also stops the growth of yeast (fungus) that causes an infection, by decreasing the production of ergosterol. Miconazole went over-the-counter in 1996.
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But, antifungal resistance has become a problem for some diagnosed with a vaginal yeast infection and using azole antifungals. Evidently, Brexafemme can overcome this problem, because it has a distinct fungicidal mechanism of action that kills a wide range of candida species, including strains resistant to azole antifungal medications. Initially, Brexafemme’s target sub-population will likely be women with azole-resistant infections or those who don’t respond to or can’t tolerate existing drugs.
The estimated list price for a four-tablet course of Brexafemme treatment ranges from $350 to $450. This would be the cost, for example, to an uninsured person. For most insured persons the out-of-pocket cost, in the form of a co-payment or co-insurance, would be lower. By comparison, a prescription for generic fluconazole has an average retail price of around $41. On the GoodRx website generic fluconazole sells for $30. Generic miconazole, which can be obtained without a prescription, costs about half of that at pharmacies.
At the estimated list price of between $350 and $450, payers are likely to institute formulary restrictions. Despite Brexafemme being the first of its kind antifungal drug, it will likely be viewed by payers in most instances as a second- or even third-line option. Besides placing Brexafemme on relatively high patient cost-sharing tiers, payers may resort to extensive use of prior authorization and step edits – fail first on a preferred agent before being prescribed Brexafemme – to limit utilization to a sub-population of women who don’t respond to traditional antifungals or have azole-resistant infections.