CurrentmhnPolicy CP.CPA.132

Metronidazole Vaginal Gel (Nuvessa)

Medical necessity and prior authorization criteria for coverage of metronidazole 1.3% vaginal gel (Nuvessa) for treatment of bacterial vaginosis in eligible members; applies to health plans affiliated with Centene Corporation.

Policy Summary

Payermhn

PolicyMetronidazole Vaginal Gel (Nuvessa)

Policy CodePolicy CP.CPA.132

Change TypeNo material changes

Effective DateNov 16, 2016

Next Review DateNov 25, 2025

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseapproval duration

>=12 yrsminimum age

1.3% (65 mg)strength / content

try 0.75% firststep therapy

Coverage Criteria

Bacterial Vaginosis (Initial therapy)

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Bacterial Vaginosis coverage: Diagnosis of bacterial vaginosis.

Age requirement: Patient is age ≥ 12 years.

Step therapy / prior therapy: Member has used metronidazole 0.75% vaginal gel unless it is contraindicated, clinically significant adverse effects occurred, or documentation supports medical necessity for metronidazole 1.3% vaginal gel.

Dose restriction: Dose does not exceed one applicator (5 g) as a single intravaginal bedtime dose (approximately 65 mg metronidazole).dose ≤ one applicator

Approval duration: 1 month (one dose)

Other diagnoses/indications

For other diagnoses or requests not covered above:

Other indications: If the drug has had a label change within the last 6 months that is not yet reflected in this policy, follow the applicable no-coverage/non-formulary policy for the relevant line of business (see CP.CPA.190).

Other indications: If the requested use (diagnosis, age, dosing regimen) is not listed under section III (diagnoses/indications not authorized) and criterion 1 does not apply, refer to the off-label use policy CP.CPA.09 for consideration.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Nuvessa. Requests will be approved only when all clinical criteria below are met. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets the criteria.

Diagnosis: Bacterial vaginosis must be documented.
Age: Member must be ≥ 12 years.
Step therapy: Member must have used metronidazole 0.75% vaginal gel (one applicatorful) unless there is a contraindication, clinically significant adverse effect, or documentation supports necessity of metronidazole 1.3% vaginal gel.
Dose limit: Approval limited to one applicator as a single dose; approval duration = 1 month (one dose).

Step Therapy

Step Therapy Requirement

Step therapy requirement: metronidazole 0.75% vaginal gel must be tried prior to approval of Nuvessa unless contraindicated or a clinically significant adverse event has occurred. Provide documentation of prior use or rationale for exception.

Preferred alternative: metronidazole gel 0.75% (one applicatorful, ~37.5 mg intravaginally).
Exception: Document contraindication or clinically significant adverse effects to metronidazole 0.75% or clinical justification for metronidazole 1.3% gel.

Documentation Required

Required supporting documentation: submit office notes, laboratory results, or other clinical information demonstrating the diagnosis, age, prior medication use (including dates and response), and any contraindications or adverse reactions that support exceptions to step therapy.

Documentation of bacterial vaginosis diagnosis.
Documentation of member age (≥ 12 years).
Records showing trial of metronidazole 0.75% vaginal gel or documentation of contraindication/adverse event.
If requesting for non‑FDA indication, include evidence per off-label use policy CP.CPA.09.

Denial Risk

Off‑Label/Non‑FDA Indications — Denial Risk

Requests for non‑FDA approved indications may be denied if sufficient documentation of efficacy and safety is not provided in accordance with the off‑label use policy.

Off‑label requests must include clinical evidence supporting efficacy and safety (refer to CP.CPA.09).
Lack of adequate documentation may result in denial.

Background

Nuvessa is a metronidazole 1.3% vaginal gel, a nitroimidazole antimicrobial indicated for treatment of bacterial vaginosis in females aged 12 years and older. The product is supplied as a single prefilled applicator (5 g) containing approximately 65 mg of metronidazole and is administered as a single intravaginal dose at bedtime.

Definitions

Nuvessa — product definition

Generic nameMetronidazole 1.3% vaginal gel

Brand nameNuvessa

Drug classNitroimidazole antimicrobial

FormulationPrefilled intravaginal gel (5 g applicator)

Dosage

Dosing regimenOne applicator (5 g) intravaginally as a single dose at bedtime

Metronidazole content per applicatorApproximately 65 mg per 5 g applicator

Maximum dosing frequency1 applicator/day (single-dose approval)

Supply formatPrefilled 5 g applicator containing 1.3% gel