LUZU, Luliconazole Form

Luliconazole cream (Luzu™) is an azole antifungal. FDA Approved Indication(s) Luzu is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Luzu is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Tinea Infections (must meet all):

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, see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated;
2. If request is for brand Luzu, member must use generic luliconazole, unless contraindicated or clinically significant adverse effects are experienced;
3. Dose does not exceed one tube (60 g) per month.
   Approval duration: 4 weeks B. Other diagnoses/indications (must meet all):
4. If request is for brand Luzu, member must use generic luliconazole, unless contraindicated or clinically significant adverse effects are experienced;

5. One of the following (a or b): a. 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 one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 5

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   Luliconazole Cream
   ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above 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 health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Tinea Infections

6. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable B. Other diagnoses/indications (must meet all):
7. If request is for brand Luzu, member must use generic luliconazole, unless contraindicated or clinically significant adverse effects are experienced;

8. One of the following (a or b): a. 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 one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above 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 health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Page 2 of 5

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   Luliconazole Cream
   Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Drug Name Dosing Regimen Apply to affected area BID Dose Limit/ Maximum Dose Varies clotrimazole cream (Desenex®, Lotrim® AF, Pro-Ex® Antifungal, Shopko® Athletes Foot), solution, ointment (Alevazol®) econazole cream, foam (Ecoza®) ketoconazole cream Apply to affected area QD Apply to affected and immediate surrounding area QD Apply to affected area BID miconazole (Lotromin AF, Cruex®, Desenex®, Micro Guard®, Zeasorb- AF®) oxiconazole cream, lotion (Oxistat®) Apply to affected area QD – Ertaczo® (sertaconazole cream) Exelderm® (sulconazole cream, solution) BID Tinea pedis: apply to affected area BID Tinea corporis/tinea cruris: apply to affected and surrounding area QD – BID Tinea pedis (cream): apply to affected area BID Varies Varies Varies Varies Varies Varies Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
   Indication Tinea pedis Tinea cruris, tinea corporis Dosing Regimen Apply to affected and immediate surrounding area(s) QD for 2 weeks Apply to affected skin and immediate surrounding area(s) QD for 1 week Maximum Dose Varies Varies VI. Product Availability
   Cream (1%): 60 g VII.