CurrentmhnPolicy CP.PMN.167

Neomycin/Fluocinolone Cream (Neo-Synalar)

Medical necessity criteria and coverage guidance for Neo-Synalar topical cream for corticosteroid-responsive dermatoses with secondary infection, applicable to members of the payer's lines of business.

Policy Summary

Payermhn

PolicyNeomycin/Fluocinolone Cream (Neo-Synalar)

Policy CodePolicy CP.PMN.167

Change TypeStep therapy bypass added for Illinois HIMproduct availability updates

Effective Date12.01.18

Next Review Date

Key ActionObtain prior authorization with documentation showing diagnosis, prior failure of a formulary topical antibacterial (unless contraindicated), and dosing within product limits.

SourceLink

POLICY UPDATE CHANGES

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

Removed 15 g package size from product availability.

Redirected Cortisporin to a formulary topical antibacterial alternative because Cortisporin topical ointment is no longer on the market.

14 daysapproval duration

2max tubes

120 gmax grams

60 gpackage size

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Initial therapy — Dermatoses

Covered when ALL of the following are met for dermatoses:

Dermatoses initial approval: 1) Diagnosis of a corticosteroid-responsive dermatosis (e.g., eczema, psoriasis, poison ivy/oak/sumac, insect bites, atopic dermatitis, seborrheic dermatitis); 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; 3) Dose does not exceed both: a) two tubes per treatment course; b) 120 g per treatment course.Approval duration: 14 days

For Illinois HIM requests, step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395.

Re-authorization

Re-authorization:

Re-authorization is not permitted; members must meet the initial approval criteria for coverage.Approval duration: Not applicable

Other/Off-label

Other diagnoses/indications:

Other uses with recent label change: If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to the appropriate no-coverage or non-formulary policy for the relevant line of business (see policy references).

Refer to CP.CPA.190, HIM.PA.33, CP.PMN.255 for on-formulary/PDL drugs or CP.CPA.190, HIM.PA.103, CP.PMN.16 for drugs not on the formulary/PDL as applicable.

Off-label or unlisted uses: If the requested use (e.g., diagnosis, age, dosing regimen) is not specifically listed under section III and the label-change path does not apply, refer to the off-label use policy for the relevant line of business.

Refer to CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid).

Non-FDA approved indications that are not addressed in this policy are not covered unless the provider submits sufficient documentation demonstrating efficacy and safety per the applicable off-label use policy for the member's line of business (see policies CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

Use of Neo-Synalar for indications other than corticosteroid-responsive dermatoses with secondary infection is discouraged. The combination product has not been shown to provide additional benefit over the steroid component alone after 7 days of treatment, so requests for other indications should be supported by strong evidence or routed to the off-label use policy as appropriate.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria for Neo‑Synalar (neomycin/fluocinolone cream). Approval duration is limited to 14 days; dose must not exceed two tubes or 120 g per treatment course.

Approval duration: 14 days
Dose limit: Two tubes per treatment course; 120 g per treatment course

Step Therapy

Step Therapy Required (IL HIM bypass)

Step therapy requires 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. For Illinois HIM requests, the step therapy requirements do not apply as of 01/01/2026 per IL HB 5395.

Required trial: formulary topical antibacterial product (see Appendix B)
IL HIM bypass effective 01/01/2026 per IL HB 5395

Documentation Required

Required Documentation for Prior Authorization

Provider must submit supporting clinical documentation with the prior authorization request — examples include office chart notes, progress notes, relevant lab results, prior treatment history, and documentation of adverse reactions or contraindications to alternatives. Documentation must demonstrate the diagnosis of a corticosteroid‑responsive dermatosis and that required trial(s) of alternatives have failed or are contraindicated.

Examples of acceptable documentation: office chart notes, lab results, prior treatment records
Documentation must support diagnosis and failure/contraindication to formulary topical antibacterial products

Denial Risk

Documentation‑based Denials

Claims may be denied if sufficient documentation is not provided to support the diagnosis, prior trial of formulary topical antibacterial therapy, dose limits, or other approval criteria. Non‑FDA approved indications are not authorized unless there is sufficient documentation per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

Denial risks: missing chart notes, no evidence of trial of formulary alternatives, exceeding dose limits, requests for non‑FDA approved indications without supporting evidence
See off‑label use policies CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace), CP.PMN.53 (Medicaid)

OpenPayer

Neomycin/Fluocinolone Cream (Neo-Synalar)

Coverage Criteria

Provider Actions & Requirements

Background

Definitions