CurrentmhnPolicy CP.PMN.166

Luliconazole Cream (Luzu)

This policy governs medical necessity and prior authorization criteria for topical luliconazole (generic and brand Luzu) for treatment of tinea pedis, tinea cruris, and tinea corporis for members covered by the payer.

Policy Summary

Payermhn

PolicyLuliconazole Cream (Luzu)

Policy CodePolicy CP.PMN.166

Change TypeMaterial — generic preference & PA added

Effective DateAug 28, 2018

Next Review Date

Key ActionPrior authorization is required and brand Luzu requests must first use generic luliconazole unless contraindicated or significant adverse effects occur.

SourceLink

POLICY UPDATE CHANGES

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

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

2failed topical azoles required

≥2minimum age

60max quantity (g)

4 wksinitial approval length

60 gproduct pack

Policy Summary

Payermhn

PolicyLuliconazole Cream (Luzu)

Policy CodePolicy CP.PMN.166

Change TypeMaterial — generic preference & PA added

Effective DateAug 28, 2018

Next Review Date

Key ActionPrior authorization is required and brand Luzu requests must first use generic luliconazole unless contraindicated or significant adverse effects occur.

SourceLink

On This Page

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Coverage Criteria

inv-01: Initial Therapy — Tinea Infections — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Tinea Infections initial approval: 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.See nodes

Approval duration: 4 weeks

inv-02: Other Diagnoses/Indications — For requests not meeting the above tinea indications or for recently changed labels:

For requests not meeting the above tinea indications or for recently changed labels:

Other indications: 1. If request is for brand Luzu, member must use generic luliconazole, unless contraindicated or clinically significant adverse effects are experienced; 2. One of the following (a or b): a. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to the appropriate policy for the relevant line of business: for drugs on the formulary/PDL use the no coverage criteria policy (CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP.PMN.255 for Medicaid) or for drugs NOT on the formulary/PDL use the non-formulary policy (CP.CPA.190 for commercial, HIM.PA.103 for marketplace, CP.PMN.16 for Medicaid); OR b. If the requested use is not listed under section III 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).

See referenced policies

inv-03: Re-authorization / Continued Therapy — 1 top-level node

Re-authorization is not permitted. Members must meet the initial approval criteria for new requests.

Approval duration: Not applicable

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the requestor provides sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for the Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents support the use.

Use of luliconazole for non‑FDA approved indications without sufficient documentation of efficacy and safety as required by the referenced off‑label use policies is considered not authorized under this policy.

Coding and Product Information

Product availabilitymixed

Cream (1%): 60 g

Product availability

inv-07: Age — minimum age for approval

Minimum age for approvalAge ≥ 2 years

Supporting criteria contextAge requirement is part of initial approval for tinea infections

Approval duration noteApproval duration for initial therapy: 4 weeks (age criterion applies to initial approval)

inv-08: Maximum quantity — One tube (60 g) per month

Maximum quantity limitOne tube (60 g) per month

Dose threshold in approval criteriaDose must not exceed one tube (60 g) per month as a condition of approval

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Generic Preference

Prior authorization is required for luliconazole and brand Luzu. Generic luliconazole requires prior authorization and, for requests for brand Luzu, the member must first use generic luliconazole unless the generic is contraindicated or causes clinically significant adverse effects.

Prior authorization required for generic luliconazole
Brand Luzu requests require prior use of generic luliconazole unless contraindicated or adverse effects

Step Therapy

Step Therapy — Topical Azole Failure

Step therapy is required for tinea infections: approval requires documentation of failure of two formulary topical azole antifungal products (e.g., clotrimazole, ketoconazole, econazole) unless clinically significant adverse effects are experienced or all are contraindicated.

Failure of two formulary topical azole antifungals required (examples: clotrimazole, ketoconazole, econazole)

Background

Luliconazole is a topical azole antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum. The product is supplied as a cream (1%) in a 60 g tube for topical application to the affected and immediately surrounding skin.

Definitions / FDA Indications

inv-14: FDA Approved Indications — topical treatment for interdigital tinea pedis, tinea cruris, and tinea corporis caused by specified organisms

Indicated conditionsTopical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis

Causative organisms listedIndicated for infections caused by Trichophyton rubrum and Epidermophyton floccosum

Route and formulationTopical (luliconazole cream)