CurrentUnitedHealthcarePolicy N/A

Brexafemme (ibrexafungerp) prior authorization and medical necessity

Know when UnitedHealthcare releases new policies or updates existing guidance.

Defines UnitedHealthcare prior authorization and medical necessity criteria for brexafemme (ibrexafungerp) for treatment of vulvovaginal candidiasis (VVC) and reduction of recurrent VVC (RVVC) for affected members and prescribers.

Policy Summary

PayerUnitedHealthcare

PolicyBrexafemme (ibrexafungerp) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeIndication addedtreatment requirement revised

Effective DateMay 1, 2026

Last ReviewFeb 1, 2026

Next Review DateFeb 1, 2026

Key ActionObtain prior authorization; approvals issued for 6 months (30-day trial exception applies in CT, KY, MS).

SourceLink

POLICY UPDATE CHANGES

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

Added the new indication for recurrent vulvovaginal candidiasis (RVVC).

Updated mandated states and references.

6 monthsauthorization duration

Adults & post‑menarchalindicated populations

3+P&T approvals

CT, KY, MS30-day trial exception

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Coverage Criteria for Brexafemme (ibrexafungerp)

Treatment of vulvovaginal candidiasis (VVC)

Covered when ALL of the following are met:

VVC initial approval: 1) Diagnosis of vulvovaginal candidiasis (VVC).

VVC step requirement: 2) One of the following: a) Confirmed azole resistance demonstrated by culture and susceptibility testing; OR b) Both of the following: i) Other causes (including but not limited to bacterial vaginosis or trichomoniasis) have been ruled out; AND ii) Failure of oral fluconazole therapy for the current episode of VVC.

Prescriber requirement: 3) 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: 1) Diagnosis of recurrent vulvovaginal candidiasis (RVVC).

RVVC step requirement: 2) One of the following: a) Confirmed azole resistance demonstrated by culture and susceptibility testing; OR b) Both of the following: i) Other causes (including but not limited to bacterial vaginosis or trichomoniasis) have been ruled out; AND ii) Failure of a maintenance course of oral fluconazole defined as 100-mg, 150-mg, or 200-mg taken weekly for 6 months.

Prescriber requirement: 3) Prescribed by or in consultation with an Infectious Disease physician or an Obstetrician/Gynecologist.

State mandates and member benefit plans may modify coverage requirements for brexafemme (ibrexafungerp). Authorization will be issued for 6 months under this policy, but other federal regulatory requirements, state mandates, the member's specific benefit plan coverage, and other utilization management programs may affect coverage and requirements. For Connecticut, Kentucky, and Mississippi business, a 30-day trial exception applies to the authorization duration.

UnitedHealthcare may approve initial requests or reauthorizations based solely on prior claim or medication history, diagnosis codes (ICD‑10), and/or automated claim logic despite the written coverage criteria. The use and availability of automated approval and re-approval processes may vary by program and therapeutic class.

Coding and Maintenance Therapy Details

Fluconazole maintenance course duration

Dose strengths100-mg, 150-mg, or 200-mg

Dosing frequencyTaken once weekly

Course duration6 months (maintenance regimen)

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required; approval duration

Prior authorization is required for brexafemme (ibrexafungerp). Approvals are issued for 6 months; for Connecticut, Kentucky, and Mississippi business only a 30‑day trial will be required.

Step Therapy

Step therapy: azole resistance or fluconazole failure + exclusion of other causes

Members must meet step therapy before approval: either confirmed azole resistance by culture/susceptibility testing OR both exclusion of other causes and failure of fluconazole (current-episode failure for VVC; failure of a 6‑month weekly maintenance fluconazole regimen for RVVC).

VVC: failure of oral fluconazole therapy for the current episode (if azole resistance is not documented).
RVVC: failure of a maintenance course of oral fluconazole defined as 100 mg, 150 mg, or 200 mg weekly for 6 months (if azole resistance is not documented).
Alternatively, documented culture/susceptibility demonstrating azole resistance satisfies the step requirement.

Background

Brexafemme (ibrexafungerp) is indicated for the treatment of vulvovaginal candidiasis (VVC) and to reduce the incidence of recurrent VVC (RVVC) in adult and post‑menarchal pediatric females. Clinical approval under this policy requires documentation of diagnosis, exclusion of other causes of vaginitis, and evidence of azole resistance or prior fluconazole treatment failure depending on the indication. Prescriptions must be by or in consultation with an Infectious Disease physician or an Obstetrician/Gynecologist. Authorization length under the policy is 6 months, with certain state-specific exceptions noted.

Definitions

VVC — Vulvovaginal candidiasis (VVC)

DefinitionVulvovaginal candidiasis (VVC)

Indicated populationAdults and post‑menarchal pediatric females

Diagnosis requirementClinical diagnosis of vulvovaginal candidiasis documented in the chart

RVVC — Recurrent vulvovaginal candidiasis

DefinitionRecurrent vulvovaginal candidiasis (RVVC): repeated episodes of vulvovaginal candidiasis

Management prior to brexafemmeFailure of a maintenance course of oral fluconazole defined as 100-mg, 150-mg, or 200-mg taken weekly for 6 months

Other requirements

Documentation Required

Required documentation to support approval

Submit documentation confirming the diagnosis (VVC or RVVC). If claiming azole resistance, include culture and susceptibility results. If using the ‘‘failure’’ pathway, document exclusion of other causes (e.g., bacterial vaginosis, trichomoniasis) and evidence of fluconazole failure (current-episode failure for VVC or a 6‑month weekly maintenance course for RVVC).

Diagnosis: clear documentation of VVC or RVVC.
Culture and susceptibility report when azole resistance is asserted.
Notes or test results documenting other causes were ruled out (including but not limited to bacterial vaginosis or trichomoniasis).
For VVC: record showing failure of oral fluconazole therapy for the current episode.
For RVVC: record showing failure of a maintenance course of oral fluconazole (100 mg, 150 mg, or 200 mg weekly for 6 months).
Prescriber specialty or evidence of consultation with Infectious Disease or OB/GYN.

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