CurrentUnitedHealthcarePolicy N/A

Vivjoa (ibrexafungerp) prior authorization for recurrent vulvovaginal candidiasis

This document governs prior authorization requirements for the drug Vivjoa for beneficiaries (NC Medicaid/NC Health Choice) with recurrent vulvovaginal candidiasis; it affects prescribing providers requesting pharmacy benefit coverage in North Carolina.

Policy Summary

PayerUnitedHealthcare

PolicyVivjoa (ibrexafungerp) prior authorization for recurrent vulvovaginal candidiasis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete the Vivjoa Pharmacy Prior Approval Request form with mandatory signature and document a 6‑month trial and failure of monthly maintenance oral fluconazole or provide contraindication/intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6Required fluconazole trial (months)

NC Medicaid / NC Health ChoicePayer programs

MandatoryPrescriber signature

>=3?Recurrent episodes referenced

Coverage Criteria

Initial authorization criteria

Covered when ALL of the following are documented on the prior authorization form:

Primary criteria: 1) Diagnosis of recurrent vulvovaginal candidiasis with laboratory-confirmed episodes in a 12-month period (form text contains '23' which appears to be an error); 2) Beneficiary is a biological female who is postmenopausal or permanently infertile (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy) as indicated on the form; 3) No hypersensitivity to any component of the product; 4) Beneficiary is not pregnant; 5) Beneficiary is not lactating; 6) Trial and failure of, or documented contraindication/intolerance to, monthly maintenance oral fluconazole for 6 months; 7) Prescriber signature and date are provided on the prior authorization form.

All items are captured as yes/no questions on the Vivjoa NC Medicaid/NC Health Choice prior approval form; prescriber signature is mandatory.

Pregnant or lactating beneficiaries are excluded from approval unless otherwise specified. The prior authorization form includes explicit yes/no questions asking whether the beneficiary is pregnant (Question 4) and whether the beneficiary is lactating (Question 5); these fields must be completed and a response indicating pregnancy or lactation will preclude approval under the stated criteria.

Provider Actions & Submission Requirements

Policy Summary

PayerUnitedHealthcare

PolicyVivjoa (ibrexafungerp) prior authorization for recurrent vulvovaginal candidiasis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

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Prior Authorization

Prior Authorization Required

Prior Authorization Required: Vivjoa requires prior authorization. The prescriber must complete and sign the Vivjoa Pharmacy Prior Approval/Prior Authorization form (NC Medicaid / NC Health Choice).

Prescriber signature is mandatory on the NC Medicaid/NC Health Choice form.
Submit completed form with all required fields (beneficiary and prescriber identifiers, drug name/strength/quantity, length of therapy).

Documentation Required

Required Documentation on Prior Approval Form

Required documentation on the prior approval form: include beneficiary identifiers and demographics, prescriber identifiers, drug details, and the clinical information fields below. Incomplete forms may delay processing.

Beneficiary: name, beneficiary ID, date of birth, gender.
Prescriber: prescribing provider NPI, requester contact information.
Drug: drug name, strength, quantity per 30 days, requested length of therapy (e.g., 30, 60, 90, 120, 180, 365 days, or other).
Clinical fields (must be completed on the form): diagnosis, number of laboratory‑confirmed VVC episodes in the past 12 months, pregnancy/lactation status, hypersensitivity to product components, documentation of prior antifungal therapy trial/failure or contraindication/intolerance.
Prescriber attestation: prescriber signature and date certifying accuracy of information.

Step Therapy

Required Prior Antifungal Therapy

Required prior antifungal therapy: approval requires documentation of a trial and failure of, or a documented contraindication or intolerance to, monthly maintenance oral fluconazole for 6 months prior to approval.

Record on the form whether the beneficiary has tried monthly maintenance oral fluconazole for 6 months and indicate failure, intolerance, or contraindication as applicable.
If fluconazole was not used for 6 months, provide rationale and supporting clinical documentation.

Denial Risk

Potential Denial Triggers

Potential denial triggers: applications will be denied if the form fails to document the diagnosis or required clinical information.

No documentation of recurrent vulvovaginal candidiasis with laboratory‑confirmed episodes in the specified 12‑month period (number of confirmed VVC episodes not provided).
Missing prescriber signature or mandatory prescriber information (e.g., NPI).
Missing beneficiary identifiers (name, ID, DOB) or missing drug details (name, strength, quantity, length of therapy).
Failure to document trial and failure of, or contraindication/intolerance to, monthly maintenance oral fluconazole x6 months when required.
Evidence of pregnancy or lactation without appropriate counseling or documentation if relevant to approval criteria.

Definitions

Recurrent vulvovaginal candidiasis (RVVC) — form wording and interpretation

Form question wordingAs written on the form: 'Does the beneficiary have a diagnosis of recurrent vulvovaginal candidiasis with 23 laboratory confirmed episodes of vulvovaginal candidiasis (VVC) in a 12-month period?'

Interpreted definitionIntended to capture recurrent VVC defined as multiple laboratory-confirmed episodes within a 12-month period; the numeric '23' is a typographical error in the form text.

Required documentationPrior authorization form must document laboratory-confirmed episodes within a 12-month period (yes/no response).

Potential denial triggerFailure to document recurrent VVC with laboratory-confirmed episodes in the specified 12-month period may result in denial.

Related prescriber questionsForm also requires documentation of biological sex/infertility status, hypersensitivity, pregnancy/lactation status, prior fluconazole trial, and prescriber signature.

Background

Recurrent vulvovaginal candidiasis (RVVC) is characterized by multiple episodes of vulvovaginal Candida infection occurring within a 12-month period and may require maintenance antifungal therapy. The prior authorization form for Vivjoa focuses on RVVC by asking the prescriber to confirm a diagnosis of recurrent VVC with laboratory-confirmed episodes within a 12-month period, to document biological female status or permanent infertility, to confirm absence of hypersensitivity, and to attest that the patient has tried and failed (or has a contraindication/intolerance to) monthly maintenance oral fluconazole for 6 months. The prescriber’s signature and date are required on the form to certify the information provided.

Initial Therapy Criteria

Initial therapy requirements

Initial approval requires documentation of prior therapies and the beneficiary's clinical status:

Initial therapy nodes: Documented diagnosis of recurrent vulvovaginal candidiasis (laboratory-confirmed episodes within a 12-month period); beneficiary biological sex/status as indicated (postmenopausal or permanently infertile) per form; not pregnant; not lactating; no hypersensitivity to product components; documentation of trial and failure of, or contraindication/intolerance to, monthly maintenance oral fluconazole for 6 months; prescriber signature present on form.6 months

The form requests documentation that the beneficiary has tried monthly maintenance oral fluconazole for 6 months and either failed or has a contraindication/intolerance.

Step Therapy Requirements

Step	Requirement
1	Documented trial and failure of monthly maintenance oral fluconazole for 6 months, or documented contraindication/intolerance to monthly maintenance oral fluconazole x 6 months.

Quantity Limits

Vivjoa — Quantity per 30 days

Field on formQuantity Per 30 Days — provider selects the amount to be dispensed per 30 days.

UnitsDisplayed on the form as 'Quantity Per 30 Days' (no specific numeric default on form).

Provider responsibilityPrescriber must complete this field on the Vivjoa prior approval form as part of required submission data.

Vivjoa — Length of therapy (selectable)

Field on formLength of Therapy (in days) — selectable options include up to 30, 60, 90, 120, 180, 365, or Other.

Maximum selectable duration365 days is listed as a selectable option on the form.

Other optionForm provides an 'Other' choice allowing specification of a different number of days.

Provider responsibilityPrescriber must select the intended length of therapy on the Vivjoa prior approval form.