Candida albicans an infection in feminine.
Final yr, Scynexis launched Brexafemme (ibrexafungerp), indicated for vulvovaginal candidiasis, generally generally known as vaginal yeast an infection. Brexafemme is the primary and, so far, solely oral non-azole remedy for vaginal yeast infections. The product’s one-day oral dosing, along with its improved capacity – in comparison with azoles – to kill fungal cells answerable for vaginal yeast infections give it a bonus over present remedies.
Brexafemme is priced at a considerable premium in comparison with older azole remedy choices, comparable to fluconazole. There are a number of generic fluconazole merchandise available on the market. The typical value of a course of a generic prescription is round $25, whereas at launch final yr a four-tablet remedy of Brexafemme had an initial wholesale acquisition cost of $475.
Till now, gross sales of Brexafemme haven’t been sturdy. The product’s sponsor, Scynexis, reported whole internet gross sales of $1.1 million in 2021 ($0.6 million within the fourth quarter), and $0.7 million within the first quarter of 2022.
Based mostly on comparatively anemic gross sales, it is sensible that the corporate is pursuing a brand new advertising and marketing push, which options the phrase: “Yeast an infection? Say no extra”
Moreover, Scynexis has produced Section 3 information that will widen Brexafemme’s attain. Interim outcomes from two Section 3 research present the flexibility of ibrexafungerp to combat refractory fungal infections in a hospital setting. On June eighth, the corporate submitted an sNDA for for a supplemental indication for the prevention of recurrent vaginal yeast infections.
Scynexis stays assured in Brexafemme’s success, in each its initially permitted indication and a attainable subsequent indication.
In the course of the first quarter of 2022, Scynexis satisfied quite a few industrial plans so as to add Brexafemme to their formularies, increasing the potential attain of the product to about 45% of the commercially-insured population, in keeping with the MMIT insurance coverage protection monitoring database.
This does increase the query, how good is the protection? Protection isn’t typically merely a binary determination of sure or no. Most newly permitted medicine ultimately discover a place on the formulary over time. However, it’s their place on the formulary that issues. Entry is a operate of the circumstances of reimbursement that payers impose, comparable to affected person cost-sharing, prior authorization, step edits, amount limits, and indication restrictions. And these circumstances of reimbursement rely upon a bunch of things, comparable to value per unit, rebate, therapeutic interchangeability with different merchandise, clinical- and cost-effectiveness, and budgetary impression.
For a brand new product like Brexafemme that’s priced almost 20 occasions increased than generic fluconazole, payers usually impose circumstances of reimbursement which will be appreciable obstacles to affected person entry. Additional compounding the entry downside, Brexafemme has very restricted protection within the Medicare and Medicaid areas.
In a bit revealed final yr across the time of Brexafemme’s approval, I argued that pricing and reimbursement may turn out to be formidable hurdles for Brexafemme to beat. The drug’s sponsor, Scynexis, has made a dent within the industrial market, facilitating entry to the product. Nevertheless, main payer challenges stay.
