CurrentUnitedHealthcarePolicy N/A

Brexafemme (ibrexafungerp) prior authorization for VVC and RVVC

Defines UnitedHealthcare prior authorization and medical necessity criteria for coverage of Brexafemme (ibrexafungerp) for treatment of vulvovaginal candidiasis (VVC) and reduction of recurrent VVC (RVVC) in adult and post‑menarchal pediatric females.

Policy Summary

PayerUnitedHealthcare

PolicyBrexafemme (ibrexafungerp) prior authorization for VVC and RVVC

Policy CodePolicy N/A

Change TypeAdded RVVC criteriaremoved 7-day fluconazole trial requirement

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionSubmit prior authorization with diagnosis, evidence of azole resistance or documented fluconazole failure, and prescriber specialty or consultation (ID or OB/GYN).

SourceLink

POLICY UPDATE CHANGES

Removed the 7-day trial requirement of fluconazole for treatment of vulvovaginal candidiasis based on CDC guidelines.

Added indication and coverage criteria for recurrent vulvovaginal candidiasis (RVVC).

Authorization duration set to 6 months (with state-specific variations noted).

6 monthsauthorization duration (standard)

30 daysauthorization duration (CT/KY/MS exception)

2indications covered

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Coverage Criteria for Brexafemme (ibrexafungerp)

Treatment of vulvovaginal candidiasis (VVC)

Covered when ALL of the following are met

VVC diagnosis: Member is an adult or post‑menarchal pediatric female with a diagnosis of vulvovaginal candidiasis (VVC)

Microbiology or clinical failure: Either: (a) confirmed azole resistance demonstrated by culture and susceptibility testing; OR (b) both: other causes (including but not limited to bacterial vaginosis or trichomoniasis) have been ruled out AND failure of oral fluconazole therapy for the current episode of VVC

Prescriber requirement: Prescribed by or in consultation with an infectious disease physician or an obstetrician/gynecologist

Recurrent vulvovaginal candidiasis (RVVC)

Covered when ALL of the following are met

RVVC diagnosis: Member is an adult or post‑menarchal pediatric female with a diagnosis of recurrent vulvovaginal candidiasis (RVVC)

Microbiology or maintenance failure: Either: (a) confirmed azole resistance demonstrated by culture and susceptibility testing; OR (b) both: other causes (including but not limited to bacterial vaginosis or trichomoniasis) have been ruled out AND failure of a maintenance course of oral fluconazole defined as 100-mg, 150-mg, or 200-mg taken weekly for 6 months

Prescriber requirement: Prescribed by or in consultation with an infectious disease physician or an obstetrician/gynecologist

Coverage is subject to state mandates, federal regulatory requirements, and the member-specific benefit plan. These requirements may modify authorization conditions and duration; for example, certain states have different trial-duration expectations. Other UnitedHealthcare policies and utilization management programs may also apply and can affect coverage determinations.

UnitedHealthcare may use automated approval or reauthorization processes based on prior claim or medication history, diagnosis codes, and claim logic; the availability of automated approvals varies by program and therapeutic class. Requests that do not meet the stated clinical criteria may be denied through manual review or programmatic rules, and other utilization management policies may also influence adjudication.

Coding and Medication Regimens

Maintenance fluconazole regimen for RVVC — dose options and schedule

Maintenance fluconazole dosing options100 mg, 150 mg, or 200 mg taken once weekly

Maintenance duration for RVVCTaken weekly for 6 months

Use case referencedRequired as the maintenance course whose failure is referenced for RVVC coverage consideration

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required. Standard approval duration is 6 months; state mandates or member-specific benefits may alter duration (e.g., Connecticut, Kentucky, Mississippi require a 30-day trial requirement exception).

Authorization duration: 6 months (state-specific variations may apply).
State mandates and member benefit plans may impact coverage.

Step Therapy

Step Therapy and Failure Requirements

Step therapy expectations: for initial treatment of VVC, prescribers must document either confirmed azole resistance by culture/susceptibility testing or documented clinical failure of oral fluconazole for the current episode. For recurrent VVC (RVVC), members must have either confirmed azole resistance or failure of a maintenance course of oral fluconazole defined as 100 mg, 150 mg, or 200 mg weekly for 6 months (note: state-specific exceptions may apply).

Treatment (VVC): confirmed azole resistance by culture/susceptibility OR failure of oral fluconazole for the current episode.

Definitions Used in This Policy

vulvovaginal candidiasis (VVC) — diagnosis indicated in criteria

DefinitionVulvovaginal candidiasis (VVC)

Indication in criteriaDiagnosis of VVC is required for coverage of Brexafemme for treatment of the current episode

Supporting requirementEither confirmed azole resistance by culture/susceptibility testing OR other causes ruled out and failure of oral fluconazole for the current episode

recurrent vulvovaginal candidiasis (RVVC) — defined as occurrence requiring maintenance therapy and referenced for failure of maintenance fluconazole

DefinitionRecurrent vulvovaginal candidiasis (RVVC)

Coverage triggerDiagnosis of RVVC is required for consideration of Brexafemme for reduction in recurrence

Background

Brexafemme (ibrexafungerp) is an antifungal agent indicated for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) in adult and post‑menarchal pediatric females. Coverage under this policy requires a confirmed diagnosis and evidence of either azole resistance by culture/susceptibility testing or clinical failure of azole therapy/maintenance regimens as specified in the clinical criteria.

Revision History & Policy Changes

2026-05-01material_revisionLatest

Removed the 7-day trial requirement of fluconazole for treatment of vulvovaginal candidiasis based on CDC guidelines; references updated.

2025-02-01annual_review

Annual review; updated mandated states.

2024-02-01annual_review

Documentation Required

Documentation Requirements

Required documentation includes the diagnosis (VVC or RVVC), evidence of azole resistance (culture and susceptibility testing) when available, or clear documentation of clinical failure of oral fluconazole (for the current episode or failure of a 6‑month maintenance regimen for RVVC). If culture/susceptibility testing is not available, the prescriber should provide a clinical rationale explaining why testing could not be performed and document prior antifungal therapies and responses. Prescriptions must be written by or in consultation with an infectious disease physician or an obstetrician/gynecologist.

Diagnosis documented: VVC or RVVC.
Evidence of azole resistance: culture and susceptibility testing (when available).
If no testing: prescriber clinical rationale and documentation of prior antifungal treatment and outcomes.
For RVVC: documentation of failure of maintenance fluconazole (100–200 mg weekly × 6 months) if claiming maintenance failure.
Prescriber: infectious disease physician or obstetrician/gynecologist (or consult documented).