Pharmacy Clinical Policy Bulletins Aetna Medicare Prescription Drug Plan
Subject: Antifungals - Topical
Status
Drug
PR-B/D
PR
PR-QL
PR-AL
ST
M EX‡
TOC§
C
ciclopirox
C
clotrimazole/betamethasone
C
econazole
C
ketoconazole
C
nystatin
C
nystatin cream/oint/powder
C
nystatin/triamcinolone
NC
Bensal HP®(salicylic acid & benzoic acid)
X
NC
Ertaczo®(sertaconazole)
X
NC
Exelderm®(sulconazole)
X
NC
Loprox® cream, gel, shampoo, lotion®(ciclopirox)
X
NC
Lotrisone®(clotrimazole/ betamethasone)
X
NC
Mentax®(butenafine)
X
NC
Monistat-Derm®(miconazole)
X
NC
Mycostatin®(nystatin)
X
NC
Naftin®(naftifine)
X
NC
Oxistat®(oxiconazole)
X
NC
Penlac Nail Lacquer®(ciclopirox)
X
X
NC
Vusion™(miconazole/zinc oxide/white petrolatum)
X
X
Note: Criteria for oral antifungal agents fluconazole, Diflucan, Lamisil, itraconazole, Sporanox, and Vfend are discussed in Pharmacy Clinical Policy Bulletin: Antifungal, Oral Agents
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, Penlac and Vusion are subject to precertification. If precertification requirements apply Aetna considers Penlac and Vusion to be medically necessary for those members who meet ALL of the following precertification criteria:
For Penlac
A. Diagnosis of onychomycosis confirmed by either a positive KOH stain (potassium hydroxide),
positive PAS stain (para-aminosalicylic acid), or positive fungal culture AND
Member is experiencing pain which limits normal activity OR
Member has diabetes OR
Member has an iatrogenically-induced or disease-associated immunosuppression, such as that due to AIDS, antirejection treatment for bone marrow or solid organ transplant, or chemotherapy for cancer OR
Member has a systemic dermatosis with impaired skin integrity (for example, pemphigus, ichthyosis) OR
Member has a significant vascular compromise (peripheral)
AND
B. A documented:
Contraindication to one systemic (oral) alternative OR
Intolerance to one systemic (oral) alternative OR
Failure of an adequate trial of six weeks of one systemic (oral) alternative OR
Presence of hepatic dysfunction or increased risk for liver disease OR
Member is female and is pregnant
Member is < 12 yrs of age
AND
C. Member is NOT receiving a systemic (oral) antifungal agent for onychomycosis at the same time.
For Vusion
A. A documented diagnosis of diaper dermatitis complicated by candidiasis confirmed by microscopic evidence of pseudohyphae and/or budding yeast (e.g. KOH)
AND
B. Member is less than or equal to 5 years of age
Medical Exception Criteria
Bensal HP, Loprox, Ertaczo, Exelderm, Lotrisone, Mentax, Monistat-Derm, Mycostatin, Naftin, Oxistat, Penlac and Vusion are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Bensal HP, Loprox, Ertaczo, Exelderm, Lamisil spray, Lotrisone, Mentax, Monistat-Derm, Mycostatin, Naftin, Oxistat, Penlac Nail Lacquer and Vusion to be medically necessary for those members who meet any of the following criteria:
For Bensal HP, Loprox, Ertaczo, Exelderm, Lotrisone, Mentax, Monistat-Derm, Mycostatin, Naftin, Oxistat and Vusion
A documented:
Contraindication to one covered alternative indicated for the member's condition OR
Intolerance to one covered alternative indicated for the member's condition OR
Allergy to one covered alternative indicated for the member's condition OR
Failure of an adequate trial of two weeks of one covered alternative indicated for the member's condition
For Penlac
A documented:
A. Diagnosis of onychomycosis confirmed by either a positive KOH stain (potassium hydroxide),
positive PAS stain (para-aminosalicylic acid), or positive fungal culture AND
Member is experiencing pain which limits normal activity OR
Member has diabetes OR
Member has an iatrogenically-induced or disease-associated immunosuppression, such as that due to AIDS, antirejection treatment for bone marrow or solid organ transplant, or chemotherapy for cancer OR
Member has a systemic dermatosis with impaired skin integrity (for example, pemphigus, ichthyosis) OR
Member has a significant vascular compromise (peripheral)
AND
B. A documented:
Contraindication to one covered systemic (oral) antifungal alternative OR
Intolerance to one covered systemic (oral) antifungal alternative OR
Failure of an adequate trial of six weeks of one covered systemic (oral) antifungal alternative OR
Presence of hepatic dysfunction or increased risk for liver disease OR
Member is female and is pregnant
Member is < 12 yrs of age
AND
C. Member is NOT receiving a systemic (oral) antifungal agent for onychomycosis at the same time
For Vusion
A documented:
A. Diagnosis of diaper dermatitis complicated by candidiasis confirmed by microscopic evidence
of pseudohyphae and/or budding yeast (e.g. KOH)
AND
B. Member is less than or equal to 5 years of age
AND
C. A documented:
Contraindication to one covered antifungal alternative OR
Intolerance to one covered antifungal alternative OR
Allergy to one covered antifungal alternative OR
Failure of an adequate trial of six weeks of one covered antifungal alternative
* Coverage is provided through a Medicare Prescription Drug Plan Sponsor with a Medicare contract and benefits, limitations, service areas and premiums are subject to change on January 1 of each year.
Place of Service:
Outpatient
The above policy is based on the following references:
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
USPDI Drug Information for the HealthCare Professional(online through Stat!Ref). Thomson MICROMEDEX,Greenwood Village,Colorado; 2004.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists,Bethesda,Maryland; 2004.
Pierard GE, Arrese JE, Pierard-Franchimont C. Treatment and prophylaxis of tinea infections. Drugs 1996;52;209-24.
Brennan B,LeydenJJ. Overview of topical therapy for common superficial fungal infections and the role of new topical agents. J Am Acad Dermatol 1997;36:S3-8.
Gupta AK, Einarson TR, Summerbell RC, Shear NH. An overview of topical antifungal therapy in dermatomycoses. Drugs 1998;55:645-74
Lester M. Ketoconazole 2% cream in the treatment of tinea pedis, tinea cruris, and tinea corporis. Cutis 1995; 55:181-3.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics,Montvale,NJ; 2003.
Naftifine Gel Study Group. Naftifine gel in the treatment of tinea pedis: Two double blind, multicenter studies. Cutis 1991;48:85-8.
Oxistat Product Information. Elan Dermatology,San Diego,CA, December 2000
Bell-Syer SE, et.al. Oral treatments for fungal infections of the skin of the foot. Cochrane Database Syst Rev. 2002; (2): CD003584.
Cohen AD, et.al. An independent comparison of terbinafine and itraconazole in the treatment of toenail onychomycosis. J Dermatolog Treat. 2003 Dec; 14(4): 237-42.
Crawford F, Young P, Godfrey C, et al. Oral treatment s for toenail onychomycosis. Arch Dermatol. 2002;138:811-16.
Darkes MJ, et. al. Terbinafine: a review of its use in onychomycosis in adults. Am J Clin Dermatol. 2003; 4(1): 39-65. Review.
GuptaAK, Cooper EA, Lynde CW The efficacy and safety of terbinafine in children. Dermatol Clin. 2003 Jul; 21(3): 511-20.
Tosti A and Piraccini BM. Treatment of common nail disorders. Dermatol Clin 2000;18(2):339-48.
Tosti A, Piraccini B, Lorenzi S. Onychomycosis caused by nondermatophytic molds: Clinical features and response to treatment of 59 cases. J Am Acad Dermatol 2000;42(2):217-24.
Korting HC and Grundmann-Kollmann M. The hydroxypyridones: a class of antimycotics of its own. Mycoses 1997; 40:243-7.
Niewerth M and Korting HC. Management of onychomycoses. Drugs 1999;58(2):283-96.
Penlac Nail Lacquer Monograph, Aventis (Dermik),Collegeville,PA, January 2000.
GuptaAK, Fleckman P, Baran R. Ciclopirox nail lacquer: the first prescription topical therapy for onychomycosis. J Am Acad Dermatol 2000;43:570-80.
Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults.Arch Intern Med. 2003;163:2716-24.
Zahn C, Sangl J,BiermanAS, et al. Potentially inappropriate medication use in the community-dwelling elderly.JAMA. 2001;286:2823-29.
Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.