Pharmacy Prior Authorization Criteria

Brexafemme (ibrexafungerp)

Indications for Prior Authorization

Brexafemme (ibrexafungerp) tablets

• 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).

Criteria

Brexafemme

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

P & T Revisions

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

References

1. Brexafemme Tablet Prescribing Information. Scynexis, Inc.; Jersey City, NJ. November 2022.
2. 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.
3. Vulvovaginal Candidiasis - STI Treatment Guidelines. Cdc.gov. https://www.cdc.gov/std/treatment-guidelines/candidiasis.htm. Published 2021. Accessed August 12, 2022.

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Revision History

• 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.

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