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L.5.01.478
Ertaczo 2% (sertaconazole) cream
Exelderm 1% (sulconazole)
cream
Exelderm 1% (sulconazole) solution
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Ertaczo (sertaconazole) cream is indicated for the treatment of interdigital tinea pedis (athlete's foot) in immunocompetent patients 12 years of age and older caused by susceptible organisms.
Exelderm (sulconazole) 1% cream is indicated for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm), and tinea versicolor caused by susceptible organisms, and for the treatment of tinea versicolor.
Exelderm (sulconazole) 1% solution is indicated for the treatment of tinea cruris (jock itch) and tinea corporis (ring worm) caused by susceptible organisms, and for the treatment of tinea versicolor.
Prior authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Initial Evaluation
Ertaczo (sertaconazole)/Exelderm (sulconazole) may be considered medically necessary when ALL of the following criteria are met:
ONE of the following:
The request is for Ertaczo and BOTH of the following:
The individual is ≥12 years of age; AND
The individual has a documented diagnosis of interdigital tinea pedis;
The request is for Exelderm 1% cream and BOTH of the following:
The individual is ≥18 years of age; AND
The individual has a documented diagnosis of tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm) or tinea versicolor; OR
The request is for Exelderm 1% solution and BOTH of the following:
The individual is ≥18 years of age; AND
The individual has a documented diagnosis of tinea cruris (jock itch), tinea corporis (ringworm) or tinea versicolor; AND
ONE of the following:
The individual has tried and failed treatment (see definition of Failure in Policy Guidelines) with at least two covered generic topical antifungal medications (e.g., ciclopirox, econazole, ketoconazole, oxiconazole); OR
The individual has a documented intolerance or FDA labeled contraindication to ALL medications listed above.
Length of Approval: 4 weeks
Renewal Evaluation
Ertaczo (sertaconazole)/Exelderm (sulconazole) for longer than 4 weeks is not recommended and will not be approved for continuation.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
Medication Failure
Medication failure is defined as disease progression at generally accepted doses (for >4 weeks use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.
BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.
01/01/2014: New policy added.
07/23/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number L.5.01.478 added. Investigative definition updated in Policy Guidelines section.
08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
07/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug names to the top of the policy. Indications for Ertaczo (sertaconazole) and Exelderm (sulconazole) updated in policy description. Policy statement revised to state: The patient has a severe intolerance or failure (≥4 weeks treatment) of two covered generic topical antifungal medications. Sources updated.
10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Exelderm (sulconazole) 1% solution. Policy section revised to add that prior authorization is required and that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Added generic names to the policy statement and Policy Exceptions. Policy statement updated to add the following criteria: The patient is being treated for an FDA approved indication. Sources updated.
05/15/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Medically necessary policy statement criteria revised. Added statement that Ertaczo (sertaconazole)/Exelderm (sulconazole) for longer than 4 weeks is not recommended and will not be approved for continuation. Policy Exceptions updated. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders," to add information regarding BCBSMS request for medical records, and to define medication failure. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Ertaczo (sertaconazole) cream, Exelderm (sulconazole) 1% cream, and Exelderm (sulconazole) 1% solution. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary criteria updated to change "member" to "individual." Sources updated.
Ertaczo prescribing information. Lacer Pharma, LLC. December 2024. Last accessed April 2025.
Exelderm cream prescribing information. Journey Medical Corporation. July 2022. Last accessed April 2025.
Exelderm solution prescribing information. Journey Medical Corporation. November 2022. Last accessed April 2025.
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