CurrentCignaPolicy IP0513

Oteseconazole (Vivjoa) for recurrent vulvovaginal candidiasis

Defines medical necessity criteria and coverage limitations for oteseconazole (Vivjoa) to reduce recurrent vulvovaginal candidiasis in females not of reproductive potential under Cigna benefit plans.

Policy Summary

PayerCigna

PolicyOteseconazole (Vivjoa) for recurrent vulvovaginal candidiasis

Policy CodePolicy IP0513

Change TypeMaterial clinical updates and duration revision

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization; approve coverage for up to 4 months when all medical necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added 'Is ≥ 18 years of age' as an eligibility criterion.

Added requirement of at least three episodes of vulvovaginal candidiasis in a 12-month period (with note about two or more prior episodes prior to current infection).

Added 'Not pregnant' as an eligibility criterion.

Approval duration updated to 4 months (previously 'one treatment course').

Documentation requirements were removed.

≥3episodes in 12 months required

≥18minimum patient age (yrs)

4 monthsapproval duration

Contraindicateduse in reproductive/pregnant/lactating

Coverage Criteria for Oteseconazole (Vivjoa)

Recurrent vulvovaginal candidiasis (RVVC) — initial approval

Covered when ALL of the following are met

Eligibility and condition: Patient is ≥ 18 years of age; has had at least three episodes of vulvovaginal candidiasis in a 12‑month period (Note: a patient who has had two or more previous episodes in the previous 12 months prior to the current infection would meet this requirement); is not of reproductive potential (postmenopausal or permanently infertile, e.g., tubal ligation, hysterectomy, salpingo‑oophorectomy); not pregnant; not lactating.

Vivjoa is contraindicated in females of reproductive potential and in pregnant and lactating women due to prolonged drug exposure (~690 days).

Prior therapy or clinical justification: One of the following: failure, contraindication, or intolerance to oral fluconazole maintenance therapy (fluconazole 100 mg, 150 mg, or 200 mg once weekly for 6 months); OR oral fluconazole is not clinically appropriate due to drug‑drug interactions; OR documented fluconazole allergy; OR being treated for a Candida species not susceptible to fluconazole; OR patient has already started on Vivjoa and is continuing to complete the prescribed course of therapy.

Step‑therapy alternatives and exceptions per policy.

Policy Summary

PayerCigna

PolicyOteseconazole (Vivjoa) for recurrent vulvovaginal candidiasis

Policy CodePolicy IP0513

Change TypeMaterial clinical updates and duration revision

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization; approve coverage for up to 4 months when all medical necessity criteria are met.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Provider Requirements and Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. When all medical necessity criteria are met for recurrent vulvovaginal candidiasis, coverage is approved for up to 4 months.

Approval duration: up to 4 months
Condition: recurrent vulvovaginal candidiasis (see medical necessity criteria)

Step Therapy

Step therapy / alternatives

Approval requires failure, contraindication, or intolerance to oral fluconazole maintenance therapy (fluconazole 100 mg, 150 mg, or 200 mg once weekly for 6 months), or documentation that fluconazole is not clinically appropriate (drug–drug interaction, allergy, or non-susceptible Candida species), or the patient has already started Vivjoa and is continuing to complete therapy.

Required step: failure, contraindication, or intolerance to oral fluconazole maintenance therapy (100 mg, 150 mg, or 200 mg once weekly for 6 months)
Alternatives: documented drug–drug interaction, fluconazole allergy, or Candida species not susceptible to fluconazole
Continuation: prior initiation of Vivjoa may qualify for continuation to complete the course

Documentation Required

Documentation note

Receipt of sample product does not satisfy criteria requirements for coverage.

Denial Risk

Non‑specified uses

Any use other than the specified indication for recurrent vulvovaginal candidiasis is considered experimental, investigational, or unproven.

Definitions

Females not of reproductive potential — definition

DefinitionBiological females who are postmenopausal or have permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).

Policy noteVivjoa is indicated only for females not of reproductive potential; use in females of reproductive potential, pregnant, or lactating is contraindicated due to prolonged drug exposure (~690 days).

Examples of permanent infertilityTubal ligation, hysterectomy, salpingo-oophorectomy.

Recurrent vulvovaginal candidiasis (RVVC) — definition

DefinitionThree or more episodes of vulvovaginal candidiasis in a 12-month period (aligns with CDC definition).

Policy thresholdHas had at least three episodes of vulvovaginal candidiasis in a 12-month period; a patient with two or more previous episodes in the prior 12 months (before the current infection) meets this requirement.

Clinical contextRVVC was the enrollment criterion in pivotal Vivjoa studies and guides eligibility for therapy under this policy.

OpenPayer

Oteseconazole (Vivjoa) for recurrent vulvovaginal candidiasis

Coverage Criteria for Oteseconazole (Vivjoa)

Provider Requirements and Authorization

Background

Definitions