Luliconazole Cream (Luzu) (PDF)

Coverage Summary

Coverage stance: covered_with_criteria for topical luliconazole (generic) and brand Luzu with prior authorization. Scope: This policy defines medical necessity criteria, prior authorization requirements, age limits, step therapy and quantity limits for topical luliconazole (generic) and brand Luzu for treatment of tinea pedis, tinea cruris, and tinea corporis across Commercial, HIM, and Medicaid lines of business. FDA-approved indications: tinea pedis, tinea cruris, and tinea corporis. Age and quantity thresholds: minimum age ≥ 2 years and maximum quantity ≤ 60 g per month (one 60 g tube).

Minimum age≥ 2 years

Maximum quantity≤ 60 g per month (one 60 g tube)

Policy numberCP.PMN.166

Coverage stancecovered_with_criteria

Initial Therapy Criteria

I. Initial Approval Criteria - A. Tinea Infections (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of tinea pedis, tinea cruris, or tinea corporis
Age ≥ 2 years≥ 2 years
Failure of two formulary topical azole antifungal products (e.g., clotrimazole, ketoconazole, econazole, etc.) unless clinically significant adverse effects are experienced or all are contraindicated
Appendix B lists therapeutic alternatives
Illinois HIM requests: step therapy bypass applies as of 2026-01-01 per IL HB 5395
If request is for brand Luzu, member must use generic luliconazole unless contraindicated or clinically significant adverse effects are experienced
Generic luliconazole requires prior authorization; brand Luzu requests require demonstration of prior use of generic unless contraindicated

I. Initial Approval Criteria - B. Other diagnoses/indications (must meet all)

Covered for other indications only when ALL of the following are met:

ALL of the following

If request is for brand Luzu, member must use generic luliconazole unless contraindicated or clinically significant adverse effects are experienced
Generic luliconazole requires prior authorization; brand Luzu requests require demonstration of prior use of generic unless contraindicated
One of
- If the drug has undergone a label change within the last 6 months not yet reflected in this policy, refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (commercial/marketplace/Medicaid) as listed in the policy
  See CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
- If the requested use (diagnosis, age, dosing) is NOT specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business as listed in the policy

Continuation Therapy Criteria

II. Continued Therapy - A. Tinea Infections

Conditions for continued use:

Re-authorization is not permitted; members must meet the initial approval criteria

Approval duration: Not applicable

II. Continued Therapy - B. Other diagnoses/indications (must meet all)

Conditions for continued use for other indications:

If request is for brand Luzu, member must use generic luliconazole unless contraindicated or clinically significant adverse effects are experienced

Generic luliconazole requires prior authorization; brand Luzu requests require demonstration of prior use of generic unless contraindicated

One of

If the drug has undergone a label change within the last 6 months not yet reflected in this policy, refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (commercial/marketplace/Medicaid) as listed in the policy

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications NOT authorized

Not covered when:

Non-FDA approved indications that are not addressed in this policy, unless sufficient documentation of efficacy and safety is provided per off-label use policies

Refer to CP.CPA.09 for commercial, HIM.PA.154 for HIM, and CP.PMN.53 for Medicaid

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Generic luliconazole requires prior authorization per policy; requests for brand Luzu require demonstration of prior use of generic luliconazole unless contraindicated or clinically significant adverse effects.

Generic luliconazole requires prior authorization.
Requests for brand Luzu require demonstration of prior use of generic luliconazole unless contraindicated or clinically significant adverse effects.

Step Therapy

Step therapy: topical azole trial requirement

For tinea infections, member must have failed two formulary topical azole antifungal products (examples include clotrimazole, ketoconazole, econazole) unless contraindicated or clinically significant adverse effects occurred. For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Applicable Codes & Policy References

Relevant policy reference numbersmixed

CP.PMN.166	Reference Number for this clinical policy
CP.CPA.09	Commercial off-label use policy referenced
HIM.PA.154	Health insurance marketplace off-label use policy referenced
CP.PMN.53	Medicaid off-label use policy referenced
CP.CPA.190	Commercial no coverage criteria policy referenced
HIM.PA.33	Health insurance marketplace no coverage criteria policy referenced
CP.PMN.255	Medicaid no coverage criteria policy referenced
HIM.PA.103	Health insurance marketplace non-formulary policy referenced
CP.PMN.16	Medicaid non-formulary policy referenced

Clinical Evidence & References

Evidence: FDA prescribing information — "Luzu Prescribing Information, April 2020" is cited as the primary evidence source. Appendix B lists therapeutic alternatives that may be used as preferred alternatives and may require prior authorization or be subject to formulary differences.

Background

Background: Luliconazole (Luzu) is an azole antifungal indicated for topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum. The product is available as a 1% cream in a 60 g tube.

SubjectLuliconazole cream (Luzu)

Formulation1% cream, 60 g tube

StatusCURRENT

Effective date08.28.18

Last review02.26 (02.26.2026)

Revision History

10.13.22added

Added requirement for use of generic luliconazole for brand Luzu requests; references reviewed and updated. P&T approval 02.23

11.06.24added

Added luliconazole to standard template language as generic requires prior authorization; references reviewed and updated. P&T approval 02.25

10.23.25clarifiedLatest

Added step therapy bypass for Illinois HIM requests per IL HB 5395 (effective for IL HIM requests 2026-01-01); references reviewed and updated. P&T approval 02.26