EFFECTIVE 1/1/2021 Drug and Biologic Coverage Policy Effective Date ............................................ 1/1/2021 Next Review Date… ..................................... 1/1/2022 Coverage Policy Number ................................ P0046 Antifungals, Topical Table of Contents Related Coverage Resources Overview ...................................................................1 Coverage Policy Statement ......................................1 FDA Indication Criteria ..............................................2 Other Uses with Supportive Evidence Criteria .........3 Specific Additional Criteria ........................................3 Preferred Product Requirement Criteria ...................3 Conditions Not Covered............................................4 Background ...............................................................4 References ...............................................................5 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Overview This policy supports medical necessity review for topical antifungals. Coverage Policy Statement Topical antifungal products (Ertaczo® cream, Exelderm® cream/solution, Extina® foam, Jublia® topical solution, Kerydin® topical solution, Loprox® cream/shampoo, Luzu™ cream, miconazole/zinc oxide/white petrolatum ointment, Oxistat® cream/lotion, Penlac® nail lacquer solution, Vusion® ointment, Xolegel™ gel) are medically necessary when the following are met: 1. Criteria associated with FDA Indications 2. Criteria associated with Other Uses with Supportive Evidence 3. Specific Additional Criteria [when part of Cigna managed drug list or plan requirements] 4. Preferred Product Requirement Criteria [when part of Cigna managed drug list or plan requirements] Page 1 of 6 Coverage Policy Number: P0046 EFFECTIVE 1/1/2021 When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy. Approval duration is 12 months unless otherwise stated. Note: Receipt of sample product does not satisfy any criteria requirements for coverage. Documentation: When documentation is required, the prescriber must provide written documentation supporting the trials of these other agents. Documentation may include, but is not limited to, chart notes, prescription claims records, and/or prescription receipts Refer to each criteria section below. FDA Indication Criteria Non-Covered FDA Indication Criteria Product Ertaczo BOTH of the following: cream, 2% ● Individual is 12 years of age and older ● Documented diagnosis of interdigital pedis Exelderm cream, BOTH of the following: 1.0% ● Individual is 18 years of age and older ● Documented diagnosis of tinea corporis, tinea cruris, tinea pedis, or tinea versicolor Exelderm solution, BOTH of the following: 1.0% ● Individual is 18 years of age and older ● Documented diagnosis of tinea corporis, tinea cruris, tinea pedis, or tinea versicolor Extina BOTH of the following: foam, 2% ● Individual is 12 years of age and older ● Documented diagnosis of seborrheic dermatitis Jublia BOTH of the following: topical solution, ● Individual is 18 years of age and older 10% ● Documented diagnosis of onychomycosis of the toenail(s) Kerydin BOTH of the following: topical solution, 5% ● Individual is 6 years of age and older ● Documented diagnosis of onychomycosis of the toenail(s) Loprox cream, None. 0.77% Loprox BOTH of the following: shampoo, 1% ● Individual is 18 years of age and older ● Documented diagnosis of seborrheic dermatitis Luzu ● Documented diagnosis of tinea corporis, tinea cruris, tinea pedis, or tinea versicolor cream, 1% miconazole/zinc ALL of the following: oxide/white ● Pediatric individual 4 weeks of age and older petrolatum ● Documented diagnosis of diaper dermatitis ointment, 0.25%- ● Presence of candida infection 15%-81.35% The approval will be limited to a (7) day supply. Oxistat None. cream, 1% Oxistat None. lotion, 1% Penlac ● Documented diagnosis of onychomycosis of the fingernail(s) or toenail(s) Page 2 of 6 Coverage Policy Number: P0046 EFFECTIVE 1/1/2021 Non-Covered FDA Indication Criteria Product nail lacquer solution, 8% Vusion ALL of the following: ointment, 0.25%- ● Pediatric individual 4 weeks of age and older 15%-81.35% ● Documented diagnosis of diaper dermatitis ● Presence of candida infection The approval will be limited to a (7) day supply. Xolegel gel, 2% None. Other Uses with Supportive Evidence Criteria None. Specific Additional Criteria None. Preferred Product Requirement Criteria Coverage varies across plans. Refer to the customer’s benefit plan document for coverage details. Where coverage requires the use of preferred products, the following criteria apply: Approve for an individual when there is documentation of ONE of the following: • The individual has had inadequate efficacy OR contraindication according to FDA label OR significant intolerance to ALL of covered alternatives according to the table below OR • The individual is not a candidate for ALL covered alternatives according to the table below due to being subject to a warning per the prescribing information (labeling), having a disease characteristic, individual clinical factor[s], or other attributes/conditions or is unable to administer and requires this dosage formulation Employer Group Non-Covered Products and Preferred Covered Alternatives by Drug List: Non-Covered Standard / Value / Cigna Total Legacy Product Performance Advantage Savings Ertaczo ALL of the following: clotrimazole cream, econazole cream, naftifine cream (sertaconazole nitrate) cream, 2% Exelderm cream, ALL of the following: ciclopirox cream/lotion, econazole cream, ketoconazole cream, 1.0% naftifine cream, oxiconazole cream Exelderm solution, ALL of the following: ciclopirox cream/lotion, econazole cream, ketoconazole 1.0% cream/shampoo, naftifine cream, oxiconazole cream Extina BOTH of the following: ciclopirox shampoo, sulfacetamide sodium shampoo foam, 2% Jublia ALL of the following: ciclopirox nail lacquer solution, itraconazole capsules, terbinafine topical solution, tablets 10% Kerydin ALL of the following: ciclopirox nail lacquer solution, itraconazole capsules, terbinafine topical solution, 5% tablets Page 3 of 6 Coverage Policy Number: P0046 EFFECTIVE 1/1/2021 Non-Covered Standard / Value / Cigna Total Legacy Product Performance Advantage Savings Loprox cream, FOUR of the following: clotrimazole cream, econazole cream, ketoconazole cream, 0.77% naftifine cream, oxiconazole cream Loprox BOTH of the following: ketoconazole foam, sulfacetamide sodium shampoo shampoo, 1% Luzu ALL of the following: ciclopirox cream/lotion, econazole cream, ketoconazole cream, cream, 1% naftifine cream, oxiconazole cream miconazole/zinc None. oxide/white petrolatum ointment, 0.25%- 15%-81.35% Oxistat BOTH of the following: cream, 1% ● (1) generic formulation of Oxistat 1% cream ● ALL of the following: clotrimazole cream, econazole cream, ketoconazole cream, naftifine cream Oxistat BOTH of the following: lotion, 1% ● Inability to use oxiconazole 1% cream ● ALL of the following: clotrimazole cream, econazole cream, ketoconazole cream, naftifine cream Penlac BOTH of the following: itraconazole capsules, terbinafine tablets nail lacquer solution, 8% Vusion None. ointment, 0.25%- 15%-81.35% Xolegel gel, 2% FOUR formulary topical products from the following: naftifine cream/gel, econazole cream, ketoconazole cream/foam, oxiconazole cream, ciclopirox cream/gel Individual and Family Plan Covered Alternatives: Non-Covered Covered Alternative(s) Product Jublia ALL of the following: ciclopirox nail