CurrentCentenePolicy CP PMN.166

Luliconazole Cream (Luzu) - Clinical Policy

Defines medical necessity and prior authorization criteria for luliconazole (brand Luzu and generic) topical cream for treatment of tinea pedis, tinea cruris, and tinea corporis for members of Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyLuliconazole Cream (Luzu) - Clinical Policy

Policy CodePolicy CP PMN.166

Change TypeMaterial language added re: brand vs generic authorization

Effective DateAug 28, 2018

Next Review DateFeb 25, 2025

Key ActionSubmit prior authorization with documentation showing age ≥2, diagnosis of tinea pedis/cruris/corporis, and failure of two formulary topical azole antifungals.

SourceLink

POLICY UPDATE CHANGES

Added requirement that requests for brand Luzu must use generic luliconazole unless contraindicated or clinically significant adverse effects are experienced.

Added luliconazole to standard template language noting that generic requires authorization.

60 gmarketed tube size available

≥2 yrsminimum age for coverage

Failure of 2therapeutic trial requirement prior to approval

1 tube/modose limit for approval

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

Initial Therapy - Tinea Infections

Covered when ALL of the following are met

Initial Approval - Tinea Infections: 1) Diagnosis of tinea pedis, tinea cruris, or tinea corporis; 2) Age >= 2 years; 3) Failure of two formulary topical azole antifungal products (e.g., clotrimazole, ketoconazole, econazole), unless clinically significant adverse effects are experienced or all are contraindicated; 4) If request is for brand Luzu, member must use generic luliconazole unless contraindicated or clinically significant adverse effects are experienced; 5) Dose does not exceed one tube (60 g) per month.Approval duration: 4 weeks

Providers must submit documentation supporting criteria

Other Indications / Off-label Guidance

Other indications (must meet ALL of the following)

Other Diagnoses/Indications: 1) If request is for brand Luzu, member must use generic luliconazole unless contraindicated or clinically significant adverse effects are experienced; 2) If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the applicable formulary or non-formulary/no-coverage policy for the member's line of business (see CP.CPA.190; HIM.PA.33; CP.PMN.255; HIM.PA.103; CP.PMN.16); 3) If the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 above does not apply, refer to the applicable off-label use policy for the member's line of business (CP.CPA.09; HIM.PA.154; CP.PMN.53).

See referenced policies for formulary, non-formulary, and off-label guidance

Continued Therapy

Continued Therapy: Re-authorization is not permitted. Members must meet the initial approval criteria for any subsequent authorization.

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies. Refer to the off‑label use guidance in CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) or other applicable evidence of coverage documents for acceptable supporting evidence.

Requests for continued therapy (re‑authorization) are not permitted; members must meet initial approval criteria for any new authorization. Additionally, non‑FDA approved uses without sufficient supporting evidence per the referenced off‑label policies are not authorized.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required: coverage limited to patients aged ≥2 years with a diagnosis of tinea pedis, tinea cruris, or tinea corporis. If request is for brand Luzu, member must use generic luliconazole first unless contraindicated or clinically significant adverse effects are documented. Quantity limit: dose does not exceed one tube (60 g) per month. Approval duration: 4 weeks. Re-authorization is not permitted; continued therapy is not covered — members must meet initial approval criteria for each request.

Age requirement: ≥2 years
Indications: tinea pedis, tinea cruris, or tinea corporis
Step requirement for brand: generic luliconazole required prior to Luzu unless contraindicated
Quantity limit: ≤60 g (one tube) per month
Approval duration: 4 weeks
Re-authorization: not permitted

Step Therapy

Step Therapy Requirement

Product Availability and Coding

Product availability / identifiersmixed

NDC	Not specified in policy; product available as cream 1% 60 g

inv-07: Maximum supply — One 60 g tube per month

Maximum supplyOne 60 g tube per month (approval duration: 4 weeks)

Marketed tube sizeCream 1%: 60 g

Dose limit noteDose must not exceed one tube (60 g) per month

inv-08: Minimum age — >= 2 years

Minimum age for coverageAge >= 2 years

Age criterion sourceListed as part of initial approval criteria for tinea infections

Related requirement

Background

Luliconazole is an azole antifungal topical cream used for dermatologic fungal infections. Per this policy, re‑authorization is not permitted; members must meet the initial approval criteria each time coverage is requested.

Definitions

inv-14: Luliconazole (Luzu) — An azole antifungal topical cream indicated for interdigital tinea pedis, tinea cruris, and tinea corporis caused by T. rubrum and E. flo...

Medication identityLuliconazole topical cream (Luzu) — an azole antifungal

FDA‑approved indicationsInterdigital tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum

Typical dosing (per label)Apply once daily to affected area: tinea pedis for 2 weeks; tinea cruris/corporis for 1 week

Product formulationCream 1% available in 60 g tube