Last year, Scynexis launched Brexafemme (ibrexafungerp), indicated for vulvovaginal candidiasis, commonly known as vaginal yeast infection. Brexafemme is the first and, to date, only non-azole oral treatment for vaginal yeast infections. The product’s one-day oral dosage, in addition to its improved ability – compared to azoles – to kill the fungal cells responsible for yeast infections, gives it an edge over existing treatments.
The price of Brexafemme is considerably higher than older azole treatment options, such as fluconazole. There are several generic fluconazole products on the market. The average price for a course of a generic prescription is around $25, whereas at launch last year, a four-pill course of Brexafemme had an initial wholesale acquisition cost of $475.
So far, sales of Brexafemme have not been robust. Product sponsor Scynexis reported total net sales of $1.1 million in 2021 ($0.6 million in the fourth quarter) and $0.7 million in the first quarter of 2022.
Based on relatively anemic sales, it makes sense that the company would pursue a new marketing campaign, which features the phrase: “Yeast infection? Say no more”
Additionally, Scynexis has produced phase 3 data that could expand the reach of Brexafemme. Interim results from two Phase 3 studies show the ability of ibrexafungerp to fight refractory fungal infections in the hospital setting. On June 8, the company submitted an sNDA for an additional indication for the prevention of recurrent vaginal yeast infections.
Scynexis remains confident in the success of Brexafemme, both in its initially approved indication and in a possible subsequent indication.
During the first quarter of 2022, Scynexis convinced many commercial plans to add Brexafemme to their formularies, expanding the product’s potential reach to approximately 45% of the commercially insured population, according to the coverage tracking database. MMIT insurance.
This begs the question, how good is the coverage? Coverage is usually not just a binary yes or no decision. Most newly approved drugs eventually find a place on the formulary over time. But it’s their position on the form that counts. Access is subject to reimbursement conditions imposed by payers, such as patient cost sharing, pre-authorization, staged modifications, quantity limits and indication restrictions. And these reimbursement conditions depend on a multitude of factors, such as the unit price, the discount, the therapeutic interchangeability with other products, the clinical and economic effectiveness, the budgetary impact.
For a new product like Brexafemme, which is priced nearly 20 times higher than generic fluconazole, payers often impose reimbursement conditions that can pose significant barriers to patient access. To further compound the access problem, Brexafemme has very limited coverage in the Medicare and Medicaid spaces.
In an article published last year at the time of Brexafemme’s approval, I argued that pricing and reimbursement could become formidable hurdles for Brexafemme to overcome. The drug’s sponsor, Scynexis, has made inroads into the commercial market, making it easier to access the product. However, major challenges remain for payers.