Pharmacy Prior Authorization Criteria

Brexafemme (ibrexafungerp)

For diagnosis of Vulvovaginal Candidiasis
Indicated for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC).
For diagnosis of Reduction in the incidence of recurrent vulvovaginal candidiasis
Indicated in adult and post-menarchal pediatric females for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).

Step Therapy

Length of Approval: 12 Month(s)

Requested drug is being used for a Food and Drug Administration (FDA)-approved indication

AND

Trial and failure, contraindication, or intolerance to both of the following [A]:

One intravaginal product (e.g., clotrimazole, miconazole, tioconazole, terconazole, boric acid)
Oral fluconazole

2024-09-05, 2023-08-28, 2023-01-23, 2022-09-06, 2021-12-22, 2021-09-01

Brexafemme Tablet Prescribing Information. Scynexis, Inc.; Jersey City, NJ. November 2022.
Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016;62:e1-50.
Vulvovaginal Candidiasis - STI Treatment Guidelines. Cdc.gov. https://www.cdc.gov/std/treatment-guidelines/candidiasis.htm. Published 2021. Accessed August 12, 2022.

For the treatment of uncomplicated candida vulvovaginitis, topical antifungal agents or a single 150 mg oral dose of fluconazole is recommended. [2, 3]
For severe acute candida vulvovaginitis, fluconazole 150 mg, given every 72 hours for a total of 2 or 3 doses is recommended. [2]
For recurring vulvovaginal candidiasis, 7 to 14 days of induction therapy with a topical agent or oral fluconazole, followed by fluconazole weekly for 6 months is recommended. [2]

2024-09-05: 2024 Annual Review - no changes
2023-08-28: 2023 UM Annual Review. No changes
2023-01-23: Added new indication for Brexafemme for reduction in the incidence of recurrent vulvovaginal candidiasis
2022-09-06: Annual review - updated references.
2021-12-22: Per formulary strategy, update program to include an additional trial and failure requirement to one intravaginal product.
2021-09-01: New ST program.