CurrentCignaPolicy N/A

Antifungals - Vivjoa Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of Vivjoa (oteseconazole) for recurrent vulvovaginal candidiasis (RVVC) in eligible females.

Policy Summary

PayerCigna

PolicyAntifungals - Vivjoa Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAuthorization length revised

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation supporting age, RVVC episode history, and reproductive/pregnancy/breastfeeding status; approvals are for 4 months when criteria met.

SourceLink

POLICY UPDATE CHANGES

Approval duration for Recurrent Vulvovaginal Candidiasis updated to 4 months (previously 'one treatment course').

Policy Statement updated to state that all approvals are provided for the duration noted below and that when authorization is in months, 1 month = 30 days (replacing prior 'All approvals are provided for 30 days').

≥18minimum age for approval

≥3/12 moRVVC threshold

4 moapproval duration

reproductive potentialexclusion population

Coverage Criteria for Vivjoa (oteseconazole)

FDA-Approved Indication (Recurrent Vulvovaginal Candidiasis)

Covered when ALL of the following are met:

RVVC coverage criteria: A) Patient is ≥ 18 years of age; AND B) Patient has had at least three episodes of vulvovaginal candidiasis in a 12-month period (a patient with two or more previous episodes prior to the current infection meets this requirement); AND C) Patient is NOT of reproductive potential (defined as a biological female who is postmenopausal or has another reason for permanent infertility, e.g., tubal ligation, hysterectomy, salpingo-oophorectomy); AND D) Patient is NOT pregnant; AND E) Patient is NOT breastfeeding.See note: ≥3 episodes in 12 months

Approve for 4 months when all criteria are met.

Vivjoa (oteseconazole) is contraindicated and not covered for females of reproductive potential, and for individuals who are pregnant or lactating/breastfeeding. This contraindication is due to Vivjoa's prolonged drug exposure window (~690 days), which prevents adequate mitigation of embryo–fetal toxicity risks. Providers must confirm reproductive potential, pregnancy status, and breastfeeding status as part of the documentation supporting any request for coverage.

Vivjoa is considered not medically necessary for any uses other than the specified indication for recurrent vulvovaginal candidiasis (RVVC). Coverage criteria and clinical requirements in this policy apply only to the RVVC indication and will be updated if new published data support additional uses.

Policy Summary

PayerCigna

PolicyAntifungals - Vivjoa Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAuthorization length revised

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation supporting age, RVVC episode history, and reproductive/pregnancy/breastfeeding status; approvals are for 4 months when criteria met.

SourceLink

On This Page

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Coding and Key Definitions

RVVC episode threshold

RVVC episode threshold>= 3 episodes of vulvovaginal candidiasis within a 12-month period; a patient with two or more prior episodes before the current infection also meets this requirement

Alternative phrasing in policy noteA patient who has had two or more previous episodes in the prior 12 months (prior to the current infection) would meet the requirement

Approval implicationMeets diagnostic threshold required for approval for RVVC when combined with other criteria (age, reproductive status, pregnancy/breastfeeding)

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for prescription benefit coverage of Vivjoa (oteseconazole). All approvals are provided for the duration noted below. In cases where the approval is authorized in months, 1 month is equal to 30 days.

Vivjoa (oteseconazole capsules - Mycovia)

Documentation Required

Required Documentation and Billing

Providers must submit requests consistent with the terms of the member's benefit plan document and applicable laws/regulations. Use the most appropriate diagnosis and procedure codes as of the date of submission. Claims submitted without covered diagnosis or procedure codes per the applicable coverage policy will be denied as not covered.

Submit requests with current, appropriate codes at time of submission
Denials may occur for services billed for conditions/diagnoses not covered by this policy

Step Therapy

No step therapy or prior antifungal failure requirements are specified for Vivjoa in this policy.

Denial Risk

Denial Triggers and Contraindications

Claims lacking covered diagnosis or procedure codes per the applicable coverage policy will be denied. Vivjoa is contraindicated in persons of reproductive potential, pregnant, or breastfeeding individuals per the FDA‑approved indication criteria in this policy.

Denial trigger: missing covered diagnosis/procedure codes
Clinical contraindications: persons of reproductive potential, pregnant, or breastfeeding

Background on Vivjoa (oteseconazole)

Vivjoa is an azole antifungal (oteseconazole) indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. RVVC is defined as three or more episodes of vulvovaginal candidiasis within a 12‑month period. The pivotal trials enrolled patients meeting this definition. The approved coverage regimen durations include 12–14 week treatment courses depending on dosing strategy, and when policy criteria are met approvals are issued for 4 months.

Definitions

RVVC definition

Definition of RVVCRecurrent vulvovaginal candidiasis: three or more episodes of vulvovaginal candidiasis within a 12-month period

AlignmentThis definition aligns with the CDC definition as noted in the policy

Context in clinical trialsVivjoa pivotal studies enrolled females meeting this RVVC definition

Not of reproductive potential

Not of reproductive potential — core definitionBiological females who are postmenopausal or have permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy)

Policy consequencePatients who are of reproductive potential, pregnant, or lactating are contraindicated for Vivjoa due to prolonged drug exposure

Example procedures conferring permanent infertilityTubal ligation, hysterectomy, salpingo-oophorectomy