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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAHCA Brexafemme Prior Auth Coverage | OpenPayer
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    CurrentAgency for Health Care AdministrationPolicy N/A

    Brexafemme (ibrexafungerp) Coverage Criteria

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    This pharmacy policy establishes prior authorization criteria for Brexafemme (ibrexafungerp) for post-menarchal females at least 12 years of age with vulvovaginal candidiasis. Authorization is provided per prescription when the specified pregnancy-testing and fluconazole trial requirements are met.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyBrexafemme (ibrexafungerp) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionBefore requesting Brexafemme authorization, document an adequate trial and failure, contraindication, resistance, or intolerance of at least one 150 mg oral fluconazole dose.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥12 yearsMinimum patient age
    VVCCovered diagnosis
    150 mgAvailable tablet strength
    1 doseMinimum fluconazole trial
    Per prescription
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyBrexafemme (ibrexafungerp) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionBefore requesting Brexafemme authorization, document an adequate trial and failure, contraindication, resistance, or intolerance of at least one 150 mg oral fluconazole dose.
    SourceLink
    On This Page
    Coverage CriteriaProvider ActionsDefinitionsInitial Therapy CriteriaStep Therapy

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    Authorization length

    Coverage Criteria

    Initial Therapy

    Covered when all of the following are met:

    Initial therapy

    • Age and post-menarchal status: Patient is a post-menarchal female aged 12 years or older.≥ 12 years
    • Diagnosis: Patient has a diagnosis of vulvovaginal candidiasis (VVC).
    • Pregnancy testing: Female patient of reproductive potential has a negative pregnancy test.Negative pregnancy test

      Applies to female patients of reproductive potential.

    • Prior fluconazole experience

      • Adequate trial and failure of at least a single dose of 150 mg oral fluconazole.At least one 150 mg oral dose
      • Contraindication to at least a single dose of 150 mg oral fluconazole.At least one 150 mg oral dose
      • Resistance to at least a single dose of 150 mg oral fluconazole.At least one 150 mg oral dose
      • Intolerance to at least a single dose of 150 mg oral fluconazole.At least one 150 mg oral dose

    Provider Actions

    Prior Authorization

    Initial Prior Authorization Criteria

    Before requesting authorization, confirm that the patient meets all initial clinical criteria for Brexafemme (ibrexafungerp) treatment of vulvovaginal candidiasis.

    • Patient is a post-menarchal female aged 12 years or older.
    • Patient has a diagnosis of vulvovaginal candidiasis (VVC).
    • If the patient is of reproductive potential, a negative pregnancy test is required.
    Step Therapy

    Prior Fluconazole Trial

    Document an adequate trial and failure of oral fluconazole before requesting Brexafemme authorization, unless fluconazole cannot be used for a qualifying clinical reason.

    • At least a single 150 mg oral dose of fluconazole must have been tried and failed; or
    • Document a contraindication, resistance, or intolerance to at least a single 150 mg oral fluconazole dose.

    Definitions

    Definitions
    AbbreviationVVC
    DefinitionVulvovaginal candidiasis

    Initial Therapy Criteria

    Initial Therapy Criteria

    Initial therapy requires all listed criteria:

    Initial Brexafemme authorization

    • Patient eligibility: Patient is a post-menarchal female aged 12 years or older.≥ 12 years
    • Covered indication: Patient has a diagnosis of vulvovaginal candidiasis (VVC).
    • Pregnancy test: Female patient of reproductive potential has a negative pregnancy test.Negative pregnancy test

      Applies to female patients of reproductive potential.

    Step Therapy

    StepRequired prior therapyCoverage
    {"text":"1","status":""},{"text":"At least a single dose of 150 mg oral fluconazole; adequate trial and failure, contraindication, resistance, or intolerance required.","status":""},{"text":"Required before Brexafemme authorization","status":"covered"}
    Documentation Required

    Required Clinical Documentation

    The authorization request must include clinical documentation supporting each applicable initial criterion and the reason Brexafemme is being requested.

    • Patient’s age and post-menarchal status.
    • Diagnosis of vulvovaginal candidiasis (VVC).
    • Negative pregnancy test for a female patient of reproductive potential.
    • Details of the oral fluconazole trial, including the single 150 mg dose and treatment failure; or documentation of contraindication, resistance, or intolerance.
    Denial Risk

    Failure to Meet Initial Criteria

    Coverage may be denied when the patient does not meet all initial criteria or when the request lacks supporting documentation.

    • Patient is not a post-menarchal female aged 12 years or older.
    • The requested indication is not vulvovaginal candidiasis (VVC).
    • A negative pregnancy test is not documented for a female patient of reproductive potential.
    • There is no documented adequate trial and failure of at least a single 150 mg oral fluconazole dose and no documented contraindication, resistance, or intolerance.
    • Required clinical documentation is incomplete or does not substantiate the authorization request.

  1. Fluconazole prerequisite

    • Adequate trial and failure of at least a single dose of 150 mg oral fluconazole.At least one 150 mg oral dose
    • Contraindication to at least a single dose of 150 mg oral fluconazole.At least one 150 mg oral dose
    • Resistance to at least a single dose of 150 mg oral fluconazole.At least one 150 mg oral dose
    • Intolerance to at least a single dose of 150 mg oral fluconazole.At least one 150 mg oral dose