CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Oteseconazole (Vivjoa) for recurrent vulvovaginal candidiasis

Policy governs coverage and authorization criteria for Vivjoa (oteseconazole) to treat recurrent vulvovaginal candidiasis (RVVC) for Neighborhood Health Plan of Rhode Island members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOteseconazole (Vivjoa) for recurrent vulvovaginal candidiasis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient is not of reproductive potential and has RVVC (≥3 episodes in 12 months) with required prior fluconazole treatment history or contraindication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18quantity limit per treatment course

4 monthsauthorization duration per year

3+ / 12 moRVVC definition

Not of reproductive potentialrequired reproductive status

Coverage Criteria for Oteseconazole (Vivjoa)

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Initial approval criteria

Covered when ALL of the following are met:

Primary criteria: 1) Requested drug is prescribed for the treatment of recurrent vulvovaginal candidiasis (RVVC), defined as ≥3 episodes of symptomatic VVC in a 12‑month period.

Patient reproductive status: 2) Patient is not of reproductive potential (e.g., biological female who is postmenopausal or has permanent infertility such as tubal ligation, hysterectomy, or salpingo‑oophorectomy); documentation must be provided.

Prescriber: 3) Vivjoa is prescribed by, or in consultation with, an infectious disease physician or an obstetrician/gynecologist.

Prior treatment / resistance / intolerance

A: History of treatment failure to a 6‑month maintenance course of weekly oral fluconazole (e.g., recurrent acute VVC episode within 14 days of completing a 6‑month course, or recurrence after two 6‑month courses within 2 years).
B: Intolerance to fluconazole documented.
Contraindication to fluconazole or documented fluconazole resistance.

Diagnostic exclusion: 5) Other causes of vulvovaginal symptoms (e.g., bacterial vaginosis, trichomoniasis) have been ruled out.

Route restriction: 6) Requested drug is not being used in a footbath.

All indications for oteseconazole (Vivjoa) other than the FDA-approved and compendial use for recurrent vulvovaginal candidiasis (RVVC) in patients who are not of reproductive potential are considered experimental/investigational and not medically necessary.

Use of oteseconazole in patients of reproductive potential is excluded due to documented embryo-fetal toxicity risk from drug exposure; therefore therapy is limited to patients who are not of reproductive potential (for example, biological females who are postmenopausal or have permanent infertility such as tubal ligation, hysterectomy, or salpingo‑oophorectomy). Documentation of nonreproductive status is required for authorization.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — one treatment course (18 capsules) per year authorized for up to 4 months when all approval criteria are met.

Authorization: up to 4 months for one treatment course (18 capsules) per 365 days

Step Therapy

Step therapy / Prior Treatment

Step therapy / prior treatment — failure, intolerance, or contraindication to fluconazole OR documented resistance is required before approval.

Required prior treatment: trial of fluconazole (including a 6-month maintenance course) unless there is documented intolerance, contraindication, or resistance
Documentation: evidence of treatment failure (e.g., recurrence of acute VVC after completing maintenance fluconazole), intolerance, contraindication, or lab-confirmed resistance

Documentation Required

Documentation Required for Reproductive Potential

Required documentation — proof the patient is not of reproductive potential must be provided (examples: documentation of postmenopausal status, permanent infertility such as tubal ligation, hysterectomy, or salpingo‑oophorectomy).

Acceptable documentation: surgical history (hysterectomy, bilateral salpingo‑oophorectomy), clinician attestation of postmenopausal status, or other medical records showing permanent infertility

Denial Risk

Denial Triggers / Risk of Non‑Approval

Denial triggers — include patient of reproductive potential, missing required documentation, lack of prior fluconazole trial or absent documentation of intolerance/contraindication/resistance, or use for non‑FDA‑approved/experimental indications.

Denial examples: patient is of reproductive potential; no documentation of permanent infertility or postmenopausal status; no documentation of failed/intolerant/contraindicated fluconazole therapy or resistance; request for indication other than recurrent vulvovaginal candidiasis (RVVC)

Background

Recurrent vulvovaginal candidiasis (RVVC) is defined in the policy as three or more symptomatic episodes of vulvovaginal candidiasis within a 12‑month period. Oteseconazole (Vivjoa) is indicated for this specific population when additional criteria are met, including documented nonreproductive potential, prescription by or in consultation with an infectious disease physician or obstetrician/gynecologist, prior fluconazole failure/intolerance or documented resistance when applicable, and exclusion of other causes such as bacterial vaginosis or trichomoniasis. Authorization is limited to one treatment course (18 capsules) per year for up to 4 months.

Definitions

Recurrent vulvovaginal candidiasis (RVVC) — coverage criteria

Coverage thresholdThree or more episodes within 12 months is required for RVVC coverage

Authorization limitPrior authorization allows one treatment course (18 capsules) per year for up to 4 months when criteria met

Prescriber requirementPrescribed by or in consultation with an infectious disease physician or obstetrician/gynecologist

ExclusionsUse in patients of reproductive potential is excluded due to embryo‑fetal toxicity risk

Not of reproductive potential — definitions and documentation

Definition — Not of reproductive potentialBiological females who are postmenopausal or have permanent infertility (e.g., tubal ligation, hysterectomy, salpingo‑oophorectomy)

Documentation requiredProvide documentation confirming postmenopausal status or permanent infertility to support authorization

Safety rationalePatients of reproductive potential are excluded because embryo‑fetal toxicity risk cannot be adequately mitigated