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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:

  1. Precertification Criteria
  2. 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



  3. Medical Exception Criteria
  4. 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:
  1. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  4. Exelderm Product Information. Westwood-Squibb Pharmaceuticals, Inc., Buffalo, NY.
  5. Pierard GE, Arrese JE, Pierard-Franchimont C. Treatment and prophylaxis of tinea infections. Drugs 1996;52;209-24.
  6. Brennan B, Leyden JJ. Overview of topical therapy for common superficial fungal infections and the role of new topical agents. J Am Acad Dermatol 1997;36:S3-8.
  7. Gupta AK, Einarson TR, Summerbell RC, Shear NH. An overview of topical antifungal therapy in dermatomycoses. Drugs 1998;55:645-74
  8. Lester M. Ketoconazole 2% cream in the treatment of tinea pedis, tinea cruris, and tinea corporis. Cutis 1995; 55:181-3.
  9. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  10. Naftifine Gel Study Group. Naftifine gel in the treatment of tinea pedis: Two double blind, multicenter studies. Cutis 1991;48:85-8.
  11. Oxistat Product Information. Elan Dermatology, San Diego, CA, December 2000
  12. Bell-Syer SE, et.al. Oral treatments for fungal infections of the skin of the foot. Cochrane Database Syst Rev. 2002; (2): CD003584.
  13. 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.
  14. Crawford F, Young P, Godfrey C, et al.  Oral treatment s for toenail onychomycosis. Arch Dermatol.  2002;138:811-16.
  15. Darkes MJ, et. al. Terbinafine: a review of its use in onychomycosis in adults. Am J Clin Dermatol. 2003; 4(1): 39-65. Review.
  16. FDA issues health advisory regarding the safety of Sporanox products and Lamisil tablets to treat fungal nail infections. FDA Talk Paper T01-22, May 9, 2001. http://www.fda.gov/bbs/topics/answers/2001/ans01083.ht
  17. Gilbert DN, Moellering RC, Sande MA, eds.  The SanfordGuide to Antimicrobial Therapy 2003.  Antimicrobial Therapy Inc. Hyde Park, VT, 2003.
  18. Gupta AK - Non-dermatophyte onychomycosis.Dermatol  Clin. 2003; 21(2): 257-68. 
  19. Gupta AK, Cooper EA, Lynde CW The efficacy and safety of terbinafine in children. Dermatol Clin. 2003 Jul; 21(3): 511-20.
  20. Tosti A and Piraccini BM. Treatment of common nail disorders. Dermatol Clin 2000;18(2):339-48.
  21. 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.
  22. Korting HC and Grundmann-Kollmann M. The hydroxypyridones: a class of antimycotics of its own. Mycoses 1997; 40:243-7.
  23. Niewerth M and Korting HC. Management of onychomycoses. Drugs 1999;58(2):283-96.
  24. Penlac Nail Lacquer Monograph, Aventis (Dermik), Collegeville, PA, January 2000.
  25. Penlac Product Information. Aventis Pharmaceuticals, Inc, Kansas City, MO, and Dermik Laboratories, Inc, Collegeville, PA. August 2000.
  26. Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer: the first prescription topical therapy for onychomycosis. J Am Acad Dermatol 2000;43:570-80.
  27. 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.
  28. Zahn C, Sangl J, Bierman AS, 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.

December 11, 2006
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