CurrentCignaPolicy IP0166

Topical Acne - Non-Retinoid Products

Defines medical necessity and authorization requirements for coverage of specified topical non‑retinoid acne products (e.g., clindamycin‑ and minocycline‑containing products and certain combination benzoyl peroxide products) for Cigna plan members.

Policy Summary

PayerCigna

PolicyTopical Acne - Non-Retinoid Products

Policy CodePolicy IP0166

Change TypeRemoval of Dapsone criteriaOnexton preference change

Effective DateSep 1, 2025

Next Review DateSep 19, 2024

Key ActionObtain prior authorization with documentation of required prior trials, failures, contraindications, or intolerances for the requested topical product.

SourceLink

POLICY UPDATE CHANGES

Removed Dapsone products (Aczone) medical necessity criteria from this policy.

Removed Onexton preferred product requirements from Employer preferred product table.

12 monthsinitial and reauthorization approval duration

3 product groupsprimary topical categories listed

multiple examplesnamed products

Beneficial responsereauthorization condition

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Coverage Criteria for Topical Non‑Retinoid Acne Products

inv-01: Clindagel (clindamycin) — Employer Plans

Covered when BOTH of the following are met

Clindagel 1% topical gel medical necessity: 1) Trial of clindamycin phosphate 1% topical gel (the bioequivalent generic product) AND inability to take it due to a formulation difference in the inactive ingredient(s) that would result in a significant allergy or serious adverse reaction; AND 2) Failure, contraindication, or intolerance to BOTH of the following: A) dapsone 5% topical gel; B) erythromycin 2% topical gel.

Employer plan specifics

inv-02: Amzeeq (minocycline) — Employer Plans

Covered when BOTH of the following are met

Amzeeq 4% topical foam medical necessity: Documentation of failure, contraindication, or intolerance to BOTH of the following: 1) ONE topical clindamycin-containing product (for example, clindamycin topical antibiotic [various formulations], clindamycin/benzoyl peroxide 1%/5% gel, clindamycin/tretinoin 1.2%/0.025% gel); AND 2) ONE topical erythromycin-containing product (for example, erythromycin topical antibiotics [various formulations], erythromycin/benzoyl peroxide 3%/5% gel).

Employer plan specifics

inv-03: Acanya and BenzaClin — Employer Plans

Covered when BOTH of the following are met

Acanya 1.2%/2.5% topical gel medical necessity: 1) Trial of clindamycin 1.2%/benzoyl peroxide 2.5% topical gel (the bioequivalent generic product) AND inability to take it due to a formulation difference in the inactive ingredient(s) that would result in a significant allergy or serious adverse reaction; AND 2) Failure, contraindication, or intolerance to BOTH of the following: A) topical benzoyl peroxide (4% or 8% gel) with topical clindamycin (1% gel) concurrently; B) benzoyl peroxide 5%/erythromycin 3% topical gel.

Employer plan specifics

BenzaClin 1%/5% topical gel medical necessity: 1) Trial of clindamycin 1%/benzoyl peroxide 5% topical gel (the bioequivalent generic product) AND inability to take it due to a formulation difference in the inactive ingredient(s) that would result in a significant allergy or serious adverse reaction; AND 2) Failure, contraindication, or intolerance to BOTH of the following: A) topical benzoyl peroxide (4% or 8% gel) with topical clindamycin (1% gel) concurrently; B) benzoyl peroxide 5%/erythromycin 3% topical gel.

Employer plan specifics

inv-04: Clindamycin/benzoyl peroxide 1.2%/3.75% gel — Employer and Individual Plans

Covered when ONE of the following is met (per plan type)

Clindamycin phosphate/benzoyl peroxide 1.2%/3.75% gel (Employer Plans): Considered medically necessary when there is documentation of failure, contraindication, or intolerance to ONE of the following: 1) clindamycin 5%/benzoyl peroxide 1.2% topical gel; 2) clindamycin 1%/benzoyl peroxide 5% topical gel.

Employer Plans

Clindamycin phosphate/benzoyl peroxide 1.2%/3.75% gel (Individual & Family Plans): Considered medically necessary when there is documentation of failure, contraindication, or intolerance to ONE of the following: 1) clindamycin 5%/benzoyl peroxide 1.2% topical gel; 2) clindamycin 1%/benzoyl peroxide 5% topical gel.

Individual & Family Plans

inv-05: Neuac Kit — Employer Plans

Covered when ALL of the following are met

Neuac Kit medical necessity: Documentation of failure, contraindication, or intolerance to ALL of the following: 1) Neuac gel; 2) topical benzoyl peroxide (4% or 8% gel) with topical clindamycin (1% gel) concurrently; 3) benzoyl peroxide/erythromycin 5%/3% topical gel.

Employer Plans

inv-06: Onexton — Individual & Family Plans

Covered when ONE of the following is met

Onexton 1.2%/3.75% gel medical necessity: Considered medically necessary when there is documentation of failure, contraindication, or intolerance to ONE of the following: 1) clindamycin 5%/benzoyl peroxide 1.2% topical gel; 2) clindamycin 1%/benzoyl peroxide 5% topical gel.

Individual & Family Plans

Receipt of sample product does not satisfy any criteria requirements for coverage. Samples provided to the member or clinician cannot be used to meet prior trial, failure, contraindication, or intolerance requirements for coverage of the listed non‑retinoid topical acne products.

The policy identifies the listed non‑retinoid topical acne products as non‑covered unless the specified medical necessity criteria are met. Named examples include Clindagel® (clindamycin phosphate 1% gel), Amzeeq™ (minocycline 4% foam), Acanya®, BenzaClin®, Neuac®, and Onexton™. Coverage is available only through formulary exception when documentation demonstrates the required prior trials, failures, contraindications, or intolerances specified in the criteria.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Provider Actions and Prior Authorization Requirements

Prior authorization is required. Medical record documentation must demonstrate the required prior trials, failures, contraindications, or intolerances as specified for each product. Step therapy is required per product-specific criteria — members must have documented trials and failures of the referenced topical alternatives before approval.

Prior authorization required with documentation of prior trials/intolerance as specified for each product.
Step therapy required per product-specific criteria: trials and failures of listed topical clindamycin-, erythromycin-, dapsone-, benzoyl peroxide- or combination products as outlined in the Medical Necessity criteria.
Medical records must document: which specific prior products were tried, dates/duration of trials, clinical response, and evidence of failure, contraindication, or intolerance.
Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered.

Step Therapy

Step Therapy Requirements

Step therapy is required; prior trials of specified alternatives (e.g., topical clindamycin products, topical erythromycin products, topical benzoyl peroxide, dapsone 5% gel, or other listed combination products) must be documented per the product-specific criteria before the requested product will be considered medically necessary.

Example requirements from policy: failure, contraindication, or intolerance to BOTH dapsone 5% gel AND erythromycin 2% gel for Clindagel.
Amzeeq requires failure, contraindication, or intolerance to ONE topical clindamycin-containing product AND ONE topical erythromycin-containing product.
Combination products (e.g., Acanya, BenzaClin) require trial of the bioequivalent generic and failure/intolerance to the specified benzoyl peroxide + clindamycin/erythromycin alternatives.
Neuac Kit requires failure/intolerance to Neuac gel AND topical benzoyl peroxide with topical clindamycin concurrently AND benzoyl peroxide/erythromycin gel.

Documentation Required

Documentation Requirements

Medical record documentation must clearly show the clinical rationale and evidence for prior treatment failures, contraindications, or intolerances, and must be available for review at the time of authorization and for reauthorization.

Document which products were tried, dates and duration of therapy, and clinical outcome.
Include documentation of adverse reactions or contraindications when applicable (e.g., allergy to inactive ingredients).
For continuation/reauthorization, include evidence of beneficial response to therapy.

Denial Risk

Billing and Coding Denial Risk

Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered.

Use the most appropriate codes as of the date of service.
Ensure billing includes covered diagnosis/procedure codes per this Coverage Policy.

OpenPayer

Topical Acne - Non-Retinoid Products

Coverage Criteria for Topical Non‑Retinoid Acne Products

Named Products and Coding

Provider Actions, Prior Authorization, and Documentation Requirements

Background

Definitions