CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Brexafemme (ibrexafungerp) — coverage criteria for VVC and RVVC

Defines coverage and authorization criteria for Brexafemme (ibrexafungerp) for treatment of vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC) for adult and post‑menarchal pediatric females; applies to Neighborhood Health Plan of Rhode Island members in NC.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBrexafemme (ibrexafungerp) — coverage criteria for VVC and RVVC

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of prior therapies, pregnancy assessment and contraception, and required specialty consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24maximum annual quantity for RVVC

4tablets per treatment course (VVC)

6 moauthorization length (RVVC)

02/2025most recent review

Coverage Criteria for Brexafemme (ibrexafungerp)

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Vulvovaginal candidiasis (VVC) — one course

Covered when ALL of the following are met

VVC initial course criteria: 1) Prescribed by or in consultation with an infectious disease physician or obstetrician/gynecologist; 2) Documentation of assessment of pregnancy status and effective contraception throughout treatment and for at least 4 weeks after the last dose; 3) Other causes of vaginitis (e.g., bacterial vaginosis, trichomoniasis) have been ruled out; 4) The requested drug is not being used in a footbath; 5) Member has experienced failure, contraindication, or intolerance to oral fluconazole; 6) Member has experienced failure, contraindication, or intolerance to topical azole agents (e.g., clotrimazole, miconazole, terconazole).

Authorization: one month for one treatment course (4 tablets).

VVC dosing info: Brexafemme VVC dosing: 300 mg (two 150 mg tablets) given approximately 12 hours apart for a total of 600 mg (four 150 mg tablets) as one treatment course.4 tablets per course

Recurrent vulvovaginal candidiasis (RVVC) — maintenance

Covered when ALL of the following are met

RVVC criteria: 1) Prescribed by or in consultation with an infectious disease physician or obstetrician/gynecologist; 2) Documentation of assessment of pregnancy status and effective contraception throughout treatment and for at least 4 weeks after the last dose; 3) Other causes of vaginitis have been ruled out; 4) The requested drug is not being used in a footbath; 5) Member meets ONE of the following: (a) three or more episodes of symptomatic VVC in a 12-month period; (b) treatment failure of a 6-month fluconazole maintenance course (acute VVC episode within 14 days of completing the 6-month course) or acute VVC after two 6-month fluconazole courses within 2 years; (c) contraindication or documented resistance to fluconazole; (d) intolerance to fluconazole; (e) treatment failure, contraindication, or intolerance to oteseconazole (Vivjoa) with documentation provided.

Authorization: six months (24 tablets total).

RVVC dosing info: Brexafemme RVVC dosing: 300 mg (two 150 mg tablets) given approximately 12 hours apart (four 150 mg tablets) monthly for up to 6 months.4 tablets per month; yearly limit 24 tablets

Brexafemme (ibrexafungerp) is covered only for its FDA‑approved uses: treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) in adult and post‑menarchal pediatric females. All other indications not explicitly listed are considered experimental/investigational and not medically necessary and therefore not covered.

Coding, Formulations, and Quantity Limits

Covered NDC/formulation (tablet strength)NDCCovered

150 mg tablet

Brexafemme (ibrexafungerp) 150 mg tablet

Quantity limits — Brexafemme (ibrexafungerp)

VVC (single treatment course)4 tablets per treatment course (Brexafemme 300 mg given as two 150 mg tablets twice ~12 hours apart for a total of four 150 mg tablets)

RVVC (maintenance)4 tablets per month for up to 6 months (monthly total of four 150 mg tablets)

Yearly maximum for RVVC24 tablets per year (4 tablets/month × 6 months)

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. For VVC (acute) approvals, an authorization of one month (up to 4 tablets / one treatment course) may be granted. For RVVC (recurrent) approvals, an authorization of six months (24 tablets total; 4 tablets per month) may be granted when criteria are met. Quantity limits: 4 tablets per 150 mg day; VVC dosing = 4 x 150 mg tablets per treatment course; RVVC dosing = 4 x 150 mg tablets monthly for up to six months (yearly limit 24 tablets).

Authorization durations: VVC = 1 month (4 tablets); RVVC = 6 months (24 tablets total, 4 tablets/month).
Quantity limit enforcement: 4 tablets per 150 mg day; yearly limit 24 tablets for RVVC.

Documentation Required

Pregnancy Assessment and Contraception

Brexafemme is contraindicated in pregnancy and carries a boxed warning. Each treatment course must include documentation of pregnancy assessment prior to initiation and documentation of effective contraception during treatment and for at least 4 weeks after the last dose. Lack of documentation may result in denial.

Document pregnancy status for each treatment course.
Document effective contraception during treatment and ≥4 weeks after last dose.
Do not initiate in pregnant patients; follow boxed warning guidance.

Documentation Required

Required Documentation for Approval

Approval requires prescriber specialty or documented consultation (infectious disease or obstetrician/gynecologist) and clinical documentation supporting the diagnosis and prior therapies. For RVVC, provide documentation of episode history or prior maintenance therapy and any contraindications or intolerance to alternatives. Requests for use in a footbath or for indications other than VVC/RVVC will be denied as experimental/investigational.

Prescriber is the prescribing or consulting infectious disease physician or obstetrician/gynecologist.
Document ruling out other causes (e.g., bacterial vaginosis, trichomoniasis).
Do not approve requests for footbath use; consider experimental/investigational and deny.
Provide clinical notes, culture results if available, and prior treatment records.

Step Therapy

Step Therapy Requirements

Step therapy must be documented prior to approval. For VVC, member must have failure, contraindication, or intolerance to oral fluconazole and to a topical azole agent (e.g., clotrimazole, miconazole, terconazole). For RVVC, document ≥3 symptomatic VVC episodes in 12 months OR treatment failure to a 6-month maintenance fluconazole course (or recurrence within 14 days of completing a 6‑month course, or after two 6‑month courses within 2 years), or contraindication/resistance/intolerance to fluconazole. Document failure, contraindication, or intolerance to Vivjoa when applicable.

VVC: trial and failure/intolerance/contraindication to oral fluconazole AND a topical azole (clotrimazole, miconazole, terconazole).
RVVC: documentation of ≥3 episodes in 12 months OR specified fluconazole maintenance failure/recurrence OR contraindication/resistance/intolerance to fluconazole.
Document prior trials, dates, doses, and reasons for failure/intolerance/contraindication.

Background on Brexafemme (ibrexafungerp)

Brexafemme (ibrexafungerp) is indicated for the treatment of vulvovaginal candidiasis (VVC) and for the reduction in recurrence of recurrent vulvovaginal candidiasis (RVVC) in adult and post‑menarchal pediatric females. For an initial VVC treatment course, authorization of one month (4 tablets) may be granted when criteria are met, including documentation of prior failure/intolerance/contraindication to oral fluconazole and to topical azole agents, assessment of pregnancy status with effective contraception, ruling out other causes of vaginitis, and prescribing by or in consultation with an infectious disease physician or obstetrician/gynecologist. For RVVC maintenance, authorization of six months (24 tablets total) is available when the RVVC criteria are satisfied (e.g., ≥3 symptomatic VVC episodes in 12 months or failure of an adequate fluconazole maintenance course), with the same pregnancy assessment and specialist prescribing/consultation requirements.

Definitions

Definition — Recurrent vulvovaginal candidiasis (RVVC)

RVVC definition (episodes)Recurrent vulvovaginal candidiasis is defined as three or more symptomatic VVC episodes in a 12‑month period.

RVVC definition (treatment failure)Also defined as treatment failure of a 6‑month fluconazole maintenance course (e.g., acute VVC within 14 days of completing the course) or acute VVC after two 6‑month fluconazole courses within 2 years.

Alternate RVVC qualifiersIncludes documented contraindication or resistance to fluconazole, or intolerance to fluconazole, as criteria supporting RVVC designation.