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]
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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)
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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
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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 lacquer solution, itraconazole capsules, terbinafine topical solution, tablets 10%
Conditions Not Covered
Any other use is considered experimental, investigational, or unproven. Criteria will be updated as new published data are available.
Background
Professional Societies/Organizations The American Academy of Dermatology (AAD) and World Health Organization (WHO) discuss the management of fungal infections with a focus primarily to superficial mycotic infections. Recommendations list topical antifungal products and do not give preference to one agent over another. The guidelines note mycological and clinical cure of noninvasive fungal infections are usually achieved with topical monotherapy. Recommendations do affirm oral therapy is preferred to treat extensive or severe infections or to treat onychomycosis. (Drake [a] [b] [c], 1996; WHO, 2014)
Off Label Uses
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AHFS Drug Information 2019 Edition supports the following off-label uses for Ertaczo: Tinea corporis, Tinea cruris, and Tinea manuum.
Generics The FDA’s generic drug approval process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. Generic drugs must establish the following for approval: • contain the same active ingredients as the innovator drug (inactive ingredients may vary) • be identical in strength, dosage form, and route of administration • have the same use indications • be bioequivalent • meet the same batch requirements for identity, strength, purity, and quality • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products
A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used. FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs. Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.
References
1. Drake LA, Dinehart SM, Farmer ER, et al. Guidelines of care for superficial mycotic infections of the skin: onychomycosis. Guidelines/Outcomes Committee. American Academy of Dermatology. J Am Acad Dermatol. 1996 [a];34(1):116-21. 2. Drake LA, Dinehart SM, Farmer ER, et al. Guidelines of care for superficial mycotic infections of the skin: tinea corporis, tinea cruris, tinea faciei, tinea manuum, and tinea pedis. Guidelines/Outcomes Committee. American Academy of Dermatology. J Am Acad Dermatol. 1996 [b];34(2):282-6. 3. Drake LA, Dinehart SM, Farmer ER, et al. Guidelines of care for superficial mycotic infections of the skin: pityriasis (tinea) versicolor. Guidelines/Outcomes Committee. American Academy of Dermatology. J Am Acad Dermatol. 1996 [c];34(2):287-9. 4. Drug Facts and Comparisons. Facts & Comparisons® eAnswers [online]. Available from Wolters Kluwer Health, Inc. Accessed July 17, 2018. 5. Ertaczo (sertaconazole) [product information]. Valeant Pharmaceuticals North America, LLC. Bridgewater, NJ. November 2017. 6. Exelderm (sulconazole) cream [product information]. Sun Pharmaceutical Industries, Inc. Cranbury, NJ. May 2018. 7. Exelderm (sulconazole) cream [product information]. Sun Pharmaceutical Industries, Inc. Cranbury, NJ. May 2018. 8. Extina (ketoconazole) [product information]. Mylan Pharmaceuticals Inc. Morgantown, WV. August 2018. 9. Jublia (efinaconazole) [product information]. Valeant Pharmaceuticals North America, LLC. Bridgewater, NJ. September 2016. 10. Kerydin (tavaborole) [product information]. PharmaDerm. Melville, NY. August 2018. 11. Loprox (ciclopirox) cream [product information]. Medimetriks Pharmaceuticals, Inc. Fairfield, NJ. January 2016. 12. Loprox (ciclopirox) shampoo [product information]. Bausch Health US, LLC. Bridgewater, NJ. May 2019. 13. Luzu (luliconazole) [product information]. Valeant Pharmaceuticals North America, LLC. Bridgewater, NJ. February 2018. 14. Naldi L, Rebora A. Clinical practice. seborrheic dermatitis. N Engl J Med. 2009 Jan 22;260(4):387-96. 15. Oxistat (oxiconazole) [product information]. PharmaDerm. Melville, NY. February 2019. 16. Penlac (ciclopirox) [product information]. Valeant Pharmaceuticals North America, LLC. Bridgewater, NJ. June 2016.
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17. Stevens DL, Bisno AL, Chambers HF. Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections: 2014 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(2):e10-52. 18. U.S. Food and Drug Administration. Drugs@FDA. U.S. Department of Health & Human Services: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. 19. Vusion (miconazole/zinc oxide/white petrolatum) [product information]. Mylan Pharmaceuticals Inc. Morgantown, WV. August 2018. 20. World Health Organization. (2014). Guidelines on the treatment of skin and oral HIV-associated conditions in children and adults: https://apps.who.int/iris/bitstream/handle/10665/136863/9789241548915_eng.pdf;jsessionid=DA28ABB08BE 1796E82D55E9107EBAE7C?sequence=1
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