Dermatologic Antifungals – NC Standard
Restricted Product(s):
- Ecoza® Foam (econazole)
- Ertaczo® Cream (sertaconazle)
- Exelderm® (sulconazole)
- Extina® (ketoconazole)
- Ketoconazole (Extina)
- Loprox® 1% Shampoo (ciclopirox)
- Luzu® 1% Cream (luliconazole)
- Luliconazole (generic Luzu)
- Naftin® 2% Cream (naftifine cream 2%)
- Naftifine 2% cream (generic Naftin)
- Naftin® Gel (naftifine)
- Naftifine 1% gel (generic Naftin)
- Naftifine 2% gel (generic Naftin)
- Oxistat® cream (oxiconazole)
- Oxiconazole cream (generic Oxistat)
- Oxistat® Lotion (oxiconazole)
- Sulconazole 1% cream/solution (generic Exelderm)
- Xolegel® 2% (ketoconazole)
FDA Approved Use:
- Ecoza is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older
- Ertaczo cream 2% indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
- Exelderm (sulconazole nitrate) 1% cream is indicated for the treatment of tinea pedis (athlete’s foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis,* and for the treatment of tinea versicolor.
- Exelderm (sulconazole nitrate) 1% solution is indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; treatment of tinea versicolor.
- Extina Foam is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older
- Loprox Shampoo is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.
- Luzu (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older
- Naftin (naftifine hydrochloride) Cream, 2% is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum in adult patients ≥18 years of age
- Naftin (naftifine hydrochloride) Gel, is indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum
- Oxistat Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due toTrichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur
- Xologel is indicated for topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older.
Criteria for Approval of Restricted Product(s):
- The requested medication is Ecoza or Ertaczo: AND
- The patient is using the medication to treat tinea pedis; AND
- The patient has had a trial and failure of generic ketoconazole or econazole nitrate cream; OR
- The patient has a documented allergy, intolerance, or contraindication to both ketoconazole and econazole nitrate.; OR
- The requested medication is Luliconazole cream, Luzu cream, Naftin cream/gel, or naftifine cream/gel; AND
- The patient is using the medication to treat tinea pedis, tinea cruris, or tinea corporis; AND
- The patient has had a trial and failure of generic ketoconazole or econazole nitrate cream; OR
- The patient has a documented allergy, intolerance, or contraindication to both ketoconazole and econazole nitrate; OR
- The requested medication is Exelderm 1% solution or sulconazole 1% solution; AND
- The patient is using the medication to treat tinea cruris, tinea corporis, or tinea versicolor; AND
- The patient has had a trial and failure of generic ketoconazole or econazole nitrate cream; OR
- The patient has a documented allergy, intolerance, or contraindication to both ketoconazole and econazole nitrate: OR
- The requested medication is Exelderm 1% cream, sulconazole cream, Oxistat cream/lotion or oxiconazole cream/lotion; AND
- The patient is using the medication to treat tinea pedis, tinea cruris, tinea corporis, or tinea versicolor; AND
- The patient has had a trial and failure of generic ketoconazole or econazole nitrate cream; OR
- The patient has a documented allergy, intolerance, or contraindication to both ketoconazole and econazole nitrate; OR
- The requested medication is Extina, ketoconazole aerosol, Loprox 1% shampoo, and Xolegel; AND
- The patient is using the medication to treat seborrheic dermatitis; AND
- The patient has had a trial and failure of generic ketoconazole cream/shampoo and generic ciclopirox gel/shampoo; OR
- The patient has a documented allergy, intolerance, or contraindication to ketoconazole cream/shampoo and ciclopirox gel/shampoo; AND
- For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
Duration of Approval: 90 days
References:
All information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation/Update Information:
Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.
May 2023: Criteria update: Addition of new to market generic Naftin 2% gel to policy.
Feb 2022: Criteria update: Annual criteria review. No changes to policy.
Jan 2020: Criteria change: Added generic sulconazole 1% cream/solution (Exelderm) to the policy. Separated solution from cream due to different indications. Removed unrestricted/suggested alternatives.
July 2019: Criteria update: corrected ‘AND’ on criteria point #4.
June 2019: Criteria update: added generic naftifine gel to restricted products and policy.
Jul 2018: added authorized generic for Luzu to restricted products. Changed authorization length on criteria to 90 days
Apr 2017: Original utilization management criteria issued.
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