OBJECTIVES:

We analyzed the financial impact of a recently approved thermosetting, bioadhesive, antibacterial clindamycin phosphate vaginal hydrogel, XACIATO^TM, to U.S. commercial and Medicaid insurers in treating Bacterial Vaginosis (BV). The U.S. FDA granted XACIATO^TM’s regulatory approval in 2021. BV is most prevalent among reproductive-aged women and has a high rate of recurrence among those with symptomatic infection. An important factor affecting patient access to new therapies is the financial burden to insurers.

METHODS:

We retrieved retrospective real-world data from Merative^TM MarketScan^® Database containing claims from commercial and Medicaid patients with ≥2 years of continuous enrollment between January 1, 2016 and September 30, 2021. BV patients were identified as women aged 12 – 49 years with diagnosed BV and ≥1 course of treatment. Using the same database, we calculated the shares of existing medications. Medication costs were calculated using wholesale acquisition costs (WAC) obtained from a proprietary third-party database. We then summarized the potential financial impact of XACIATO^TM.

RESULTS:

We found 25,324,730 commercially insured patients, of whom 0.56% were BV patients with ≥1 course of treatment, and 0.20% with ≥2 courses (36% of BV patients with ≥1 course). There were 12,488,141 Medicaid patients, of whom 0.92% were BV patients with ≥1 course, and 0.40% with ≥2 courses (43% of BV patients with ≥1 course). Metronidazole oral was most frequently prescribed in commercial and Medicaid populations for both first and second courses (Commercial: 68%, 59%; Medicaid: 84%, 70%, respectively). The median WAC of a single course of metronidazole oral treatment was 8 U.S. Dollars.

CONCLUSIONS:

BV patients typically receive one course of inexpensive oral treatment while many (36% of commercial and 43% of Medicaid) advanced to ≥2 courses. U.S. insurers will continue to be able to manage the financial impact of BV by utilizing inexpensive oral treatment while gaining access to XACIATO^TM’s new bioadhesive hydrogel technology.