CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vivjoa

Defines coverage and authorization criteria for Vivjoa (oteseconazole) for reduction of recurrent vulvovaginal candidiasis (RVVC) in females not of reproductive potential, including required prescriber type, prior fluconazole trial/ intolerance/contraindication, exclusion of other causes, and quantity limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVivjoa

Policy CodePolicy N/A

Change TypeReviewed (no material changes)

Effective DateMar 1, 2023

Next Review DateJul 1, 2025

Key ActionObtain authorization for a 4-month (18 capsule) treatment course and provide documentation that the member meets all approval criteria including RVVC history, non-reproductive potential status, prior fluconazole trial or exemption, exclusion of other causes, and appropriate prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

Reviewed dates listed: 12/22/2022, 06/2024, 07/2025.

1Covered Indication (RVVC in non-reproductive potential females)

18Quantity Limit

>=3RVVC Diagnostic Threshold

SpecialtyProvider Requirement

Coverage Summary

Coverage stance: Covered with criteria. Vivjoa (oteseconazole) is covered only for the FDA-approved indication: reduction of recurrent vulvovaginal candidiasis (RVVC) in females who are not of reproductive potential. Authorization is limited to a 4-month treatment course (18 capsules) per 365 days, and the prescription must be written by or in consultation with an infectious disease physician or an obstetrician/gynecologist.

Indications - Covered vs Not Covered

Coverage applies only for FDA-approved indication when criteria met:

ALL of the following

Covered: Reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
Not covered (experimental/investigational and not medically necessary): All other indications.

Initial Therapy Criteria (Authorization)

Authorization (Initial) - 4 month course (18 capsules) per year

Authorization may be granted when ALL of the following are met:

ALL of the following

Requested drug is being prescribed for the treatment of recurrent vulvovaginal candidiasis (RVVC), defined as 3 or more episodes of symptomatic VVC in a 12-month period.
Member is not of reproductive potential (i.e. persons who are biological females who are postmenopausal or have another reason for permanent infertility [e.g., tubal ligation, hysterectomy, salpingo-oophorectomy]). Documentation must be provided.
Drug exposure window (~690 days) precludes adequate mitigation of embryo-fetal toxicity risks.
Vivjoa is prescribed by, or in consultation with, an infectious disease physician or obstetrician/gynecologist.
ONE of the following
- Member has experienced treatment failure to a 6-month maintenance course of weekly oral fluconazole (100 mg, 150 mg, or 200 mg) (e.g., acute VVC episode while on fluconazole therapy, acute VVC episode within 14 days of completing 6-month fluconazole course, acute VVC episode after two 6-month courses of fluconazole within 2 years).
  Documentation required.
- Member has experienced an intolerance to fluconazole.
  Documentation required.
- Member has a contraindication or documented resistance that would prohibit a trial of fluconazole.
  Documentation required.
Other causes, such as bacterial vaginosis or trichomoniasis, have been ruled out.
The requested drug is not being used in a footbath.

Key Thresholds

RVVC definition>= 3 episodes of symptomatic VVC in a 12-month period

Quantity limit18 capsules every 365 days (1 treatment course per year)

Provider Actions / Prior Authorization

Prior Authorization

Authorization required for Vivjoa

Obtain prior authorization for Vivjoa before dispensing. Authorization may be granted for a single 4-month treatment course (18 capsules) per year. Provide documentation that the member meets all approval criteria, including history consistent with RVVC, documentation that the member is not of reproductive potential, evidence other causes have been ruled out, and that the prescriber meets specialty requirements.

Documentation Required

Documentation of reproductive potential

Document that the member is not of reproductive potential. Acceptable documentation includes evidence of postmenopausal status or documentation of permanent infertility (for example: tubal ligation, hysterectomy, salpingo-oophorectomy).

Postmenopausal status
Tubal ligation
Hysterectomy
Salpingo-oophorectomy

Documentation Required

Documentation of prior fluconazole trial or exemption

Provide documentation of prior fluconazole exposure or an acceptable exemption. Either show treatment failure to a 6-month maintenance course of weekly oral fluconazole (100 mg, 150 mg, or 200 mg) — for example an acute VVC episode while on therapy, an episode within 14 days of completing the 6-month course, or recurrence after two 6-month courses within 2 years — or document intolerance, contraindication, or documented resistance to fluconazole.

Documentation Required

Rule out alternate causes

Document that other causes of vaginitis have been ruled out prior to approval. Specifically note that bacterial vaginosis and trichomoniasis must be excluded.

Rule out bacterial vaginosis
Rule out trichomoniasis

Billing Rule

Quantity limit enforcement

Enforce the quantity limit: 18 capsules every 365 days (one treatment course per year). Dispensing should be limited to one 4-month course (18 capsules) in a 365-day period.

Denial Risk

Denial if used in reproductive potential or other indications

Claims may be denied if the member is of reproductive potential, if the requested use is not for RVVC (the FDA-approved indication), or if required documentation demonstrating criteria (RVVC history, reproductive potential status, prior fluconazole trial or exemption, exclusion of other causes, prescriber specialty) is not provided.

Documentation Required

Prescriber specialty requirement

The prescription must be written by, or in consultation with, an infectious disease physician or an obstetrician/gynecologist. If prescribed in consultation, retain documentation of that consultation for review.

Clinical Evidence & References

Evidence cited: Vivjoa package insert (Mycovia Pharmaceuticals, January 2026) and the CDC Sexually Transmitted Infections Treatment Guidelines, 2021 (Vulvovaginal Candidiasis).

FDA-approved indication: to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.

Safety rationale: the product labeling and policy note an embryo-fetal toxicity risk and an extended drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole); this sustained exposure underlies the restriction of use to persons who are not of reproductive potential.

Background

Background: Vivjoa (oteseconazole) is FDA-approved to reduce recurrent vulvovaginal candidiasis (RVVC) in females who are not of reproductive potential. The policy notes an embryo-fetal toxicity risk and that the drug exposure window is approximately 690 days, which precludes adequate mitigation of those risks. All other uses of Vivjoa are considered experimental/investigational and not medically necessary.

Term	Definition
Not of reproductive potential	Biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).
Recurrent vulvovaginal candidiasis (RVVC)	3 or more episodes of symptomatic VVC in a 12-month period.

Revision History

2022-12-22reviewed

Policy reviewed (no clinical policy statement changes indicated).

2023-03-01effective

Policy effective date.

2024-06-01last_review

Policy last reviewed (no clinical policy statement changes indicated).

2024-06reviewed

Policy reviewed (no clinical policy statement changes indicated).

2025-07-01next_reviewLatest

Scheduled next review date.

2025-07reviewed

Policy reviewed (no clinical policy statement changes indicated).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVivjoa

Policy CodePolicy N/A

Change TypeReviewed (no material changes)

Effective DateMar 1, 2023

Next Review DateJul 1, 2025

SourceLink

On This Page

OpenPayer

Vivjoa

Coverage Summary

Initial Therapy Criteria (Authorization)

Provider Actions / Prior Authorization

Applicable Codes

Clinical Evidence & References

Background

Revision History