CurrentHealth NetPolicy CP CPA.132

Metronidazole Vaginal Gel (Nuvessa) Coverage Criteria

Defines medical necessity and prior authorization criteria for Nuvessa (metronidazole 1.3% vaginal gel) for treatment of bacterial vaginosis in eligible members of the plan.

Policy Summary

PayerHealth Net

PolicyMetronidazole Vaginal Gel (Nuvessa) Coverage Criteria

Policy CodePolicy CP CPA.132

Change TypeNo material change

Effective DateNov 16, 2016

Next Review DateNov 24, 2024

Key ActionSubmit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1.3%metronidazole concentration in Nuvessa

12 yrsminimum indicated age for Nuvessa

single doseapproved dosing regimen

1 moinitial approval duration

Listedcontraindications noted

Centene

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.

Coverage Criteria

inv-01: Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval: Diagnosis of bacterial vaginosis.

Initial Approval: Patient age is greater than or equal to 12 years.>= 12 years

Initial Approval: Requested dose does not exceed one applicator as a single dose.<= one applicator (single dose)

Approval duration: 1 month (one dose).

Initial Approval: Member has used metronidazole 0.75% vaginal gel unless contraindicated or clinically significant adverse effects occurred, or documentation supports medical necessity for metronidazole 1.3% vaginal gel.

inv-02: Other Diagnoses / Non-formulary or Off-label Requests

Consider per formulary and off-label policies:

Other Indications: Requests for indications not listed in this policy should follow the applicable formulary/no coverage policy (CP.CPA.190) for the relevant line of business or the off-label use policy (CP.CPA.09) when the requested use is not specifically addressed in section III of this policy.

For recent label changes (within 6 months) refer to the referenced policies as noted.

Requests for uses of metronidazole vaginal gel that are for non‑FDA approved indications and that are not specifically addressed in this policy will generally be excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the Health Plan's off‑label use policy CP.CPA.09 (or applicable evidence of coverage provisions).

Coverage determinations and the administration of benefits for this therapy are subject to all terms, conditions, exclusions, and limitations of the member's applicable coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance), as well as applicable state and federal laws and Health Plan administrative policies and procedures. This clinical policy is a guide to medical necessity and does not guarantee payment.

Re‑authorization for continued treatment with metronidazole 1.3% vaginal gel is not permitted. Members must meet the initial approval criteria each time coverage is requested; continuation/maintenance therapy approvals do not apply under this policy.

Coding

Codes referencedmixed

N/A	No specific CPT/HCPCS/ICD-10/NDC codes listed in this part of the document.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit clinical documentation (e.g., office chart notes, laboratory results, or other pertinent clinical information) supporting that the member meets all approval criteria, including documentation of a diagnosis of bacterial vaginosis, member age ≥ 12 years, and that dosing does not exceed one applicator as a single dose. Coverage decisions are subject to the member's benefit documents, plan terms, conditions, exclusions, and limitations.

Submit: office notes, labs, and other clinical records supporting diagnosis and criteria
Required diagnostic criteria: bacterial vaginosis; age ≥ 12 years
Dosing limit: ≤ one applicator as a single dose
Approval duration: 1 month (one dose)

Denial Risk

Off-Label Use Denial Risk

Requests for use of metronidazole vaginal gel for indications not approved by the FDA (off-label uses) may be denied if sufficient documentation of efficacy and safety is not provided per the Health Net off-label use policy (see CP.CPA.09) and applicable evidence of coverage documents.

Background

Bacterial vaginosis is a common vaginal infection. Nuvessa is the trade name for metronidazole 1.3% vaginal gel supplied as a prefilled 5 g applicator (approximately 65 mg metronidazole per applicator) and is FDA‑approved for treatment of bacterial vaginosis in females aged 12 years and older. When covered, the approved regimen under this policy is a single intravaginal applicator dose and prior authorization requires documentation of diagnosis, age, and dosing consistent with the product labeling and the policy's initial approval criteria.

Definitions

Nuvessa — product facts

ProductNuvessa (metronidazole) 1.3% prefilled applicator vaginal gel

Strength / Formulation1.3% vaginal gel, prefilled applicator (5 g)

Metronidazole content per applicatorApproximately 65 mg metronidazole per 5 g applicator

Approved use (per policy background)FDA‑approved for treatment of bacterial vaginosis in females aged ≥12 years as a single intravaginal applicator dose

Health Plan — definition

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates, as applicable.

Policy Summary

PayerHealth Net

PolicyMetronidazole Vaginal Gel (Nuvessa) Coverage Criteria

Policy CodePolicy CP CPA.132

Change TypeNo material change

Effective DateNov 16, 2016

Next Review DateNov 24, 2024

Key ActionSubmit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria.

SourceLink

On This Page

Off-label requests must include supporting clinical evidence demonstrating efficacy and safety
Denials may occur if documentation is insufficient or does not meet off-label policy criteria

Step Therapy

Therapeutic Alternatives / Step Therapy

Member must use metronidazole 0.75% vaginal gel (preferred therapeutic alternative) unless contraindicated, clinically significant adverse effects have occurred, or documentation supports medical necessity for metronidazole 1.3% vaginal gel. Providers should document contraindications or adverse reactions when requesting the higher-strength product.

Preferred alternative: metronidazole 0.75% vaginal gel
Exception: metronidazole 1.3% vaginal gel only if contraindication, adverse effect, or documented medical necessity

Documentation Required

Provider Responsibilities and Documentation

Providers must follow all plan terms, conditions, exclusions, and billing requirements when submitting claims. Coverage is determined by the member's benefit documents and applicable Health Plan administrative policies. Ensure prior authorization codes and plan-specific requirements are met at submission.

Adhere to plan-level billing and submission policies
Coverage subject to evidence of coverage and contract terms

ScopeApplies to the Health Plan(s) that have adopted this clinical policy; coverage decisions subject to member coverage documents and applicable law/regulation.

Policy status noteThis clinical policy is a guide to medical necessity and does not constitute a contract or guarantee of payment.