CurrentCentenePolicy CP.PMN.167

Neomycin/Fluocinolone Cream (Neo-Synalar) Coverage Criteria

Clinical policy governing medical necessity and prior authorization criteria for Neo-Synalar topical cream for corticosteroid-responsive dermatoses with secondary infection for Centene-affiliated health plans and lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyNeomycin/Fluocinolone Cream (Neo-Synalar) Coverage Criteria

Policy CodePolicy CP.PMN.167

Change TypeStep therapy bypass addedminor product availability and redirection updates

Effective Date12.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis of a corticosteroid-responsive dermatosis, failure of a formulary topical antibacterial, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Removed 15 g package size from product availability.

Updated redirection for Cortisporin to a formulary topical antibacterial product since Cortisporin topical ointment is no longer on market.

14 daysApproval duration for initial treatment course

2Maximum tubes per treatment course

120 gMaximum grams per treatment course

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Coverage Criteria

Initial therapy — Dermatoses

Covered when ALL of the following are met for dermatoses:

A. Dermatoses: 1. Diagnosis of a corticosteroid-responsive dermatosis (e.g., eczema, psoriasis, poison ivy, oak, or sumac, insect bites, atopic dermatitis, seborrheic dermatitis);

A. Dermatoses: 2. Failure of a formulary topical antibacterial product at up to maximally indicated doses (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated;

Includes step therapy requirement; exemption applies for Illinois HIM requests per IL HB 5395 effective 1/1/2026.

A. Dermatoses: 3. Dose does not exceed: a. Two tubes per treatment course; b. 120 g per treatment course.Approval duration: 14 days

Other / label-change / off-label routing

Other diagnoses/indications (alternative pathways):

B. Other diagnoses/indications: 1. If the drug has had a recent label change within 6 months not reflected in this policy, follow the listed formulary/non‑formulary/no‑coverage policies for the relevant line of business (see CP.CPA.190, HIM.PA.103, CP.PMN.16 as applicable).

B. Other diagnoses/indications: 2. If the requested use (diagnosis, age, dosing regimen) is NOT specifically listed under 'Diagnoses/Indications for which coverage is NOT authorized' AND criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid).

Re-authorization

Re-authorization:

Re-authorization is not permitted. Members must meet the initial approval criteria again for future requests.Approval duration: Not applicable

Requests for Neo-Synalar for indications that are not FDA‑approved and are not explicitly addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy for the member's line of business (see CP.CPA.09, HIM.PA.154, CP.PMN.53 or evidence of coverage documents).

Neo‑Synalar is contraindicated in patients with a known hypersensitivity to any component of the preparation. Additionally, it is contraindicated for use in the external auditory canal when the eardrum is perforated.

Clinical evidence has not shown that the neomycin/fluocinolone combination provides greater benefit than the corticosteroid component alone when treatment continues beyond 7 days. Continued use past this duration therefore lacks demonstrated added benefit.

Coding and Dose Limits

Policy identifiermixed

CP.PMN.167

Policy reference number (internal)

inv-08: Maximum treatment course dose

Maximum tubes per treatment courseTwo tubes per treatment course

Maximum grams per treatment course120 g per treatment course

Approval duration for treatment course14 days

inv-09: Maximum daily applications

Maximum daily applications4 applications/day

Usual dosing frequencyApply a thin film to affected area 2 to 4 times daily

Indication context

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Neo‑Synalar. Provider must obtain prior authorization before dispensing to ensure the request meets medical necessity criteria and quantity/duration limits.

Prior authorization required for Neo‑Synalar
Approval duration: 14 days
Dose limits: Two tubes per treatment course; 120 g per treatment course

Documentation Required

Documentation Required to Support Medical Necessity

Provider must submit documentation (such as office chart notes, relevant physical exam findings, prior treatment history, and laboratory results where applicable) demonstrating that the member meets all approval criteria. Requests submitted without sufficient supporting clinical documentation will be denied.

Required documentation: office notes, prior treatment records, lab results (if applicable)

Background

Neo‑Synalar (neomycin/fluocinolone cream) is a topical preparation combining an antibacterial (neomycin) with a low‑potency corticosteroid (fluocinolone). It is indicated for the treatment of corticosteroid‑responsive dermatoses with secondary infection.

Definitions

inv-15: Corticosteroid-responsive dermatosis

Examples of corticosteroid-responsive dermatosesEczema; psoriasis; poison ivy, oak, or sumac; insect bites; atopic dermatitis; seborrheic dermatitis

Indication requirementTreatment is for corticosteroid-responsive dermatoses with secondary infection

Clinical noteCombination has not shown greater benefit than steroid alone after 7 days