Subject: Topical Antifungals

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	ciclopirox (dosage forms other than solution)
C	ciclopirox solution		X
C	clotrimazole/betamethasone
C	econazole
C	ketoconazole
C	nystatin
C	nystatin cream/oint/powder
C	nystatin/triamcinolone
NC	Ertaczo®  (sertaconazole)						X
NC	Exelderm®  (sulconazole)						X
NC	Extina®  (ketoconazole foam)						X
NC	Halotin®  (haloprogin)						X
NC	Lamisil® spray  (terbinafine hcl)						X
NC	Loprox® cream, gel, shampoo, lotion®  (ciclopirox)						X
NC	Lotrisone®  (clotrimazole/ betamethasone)						X
NC	Mentax®  (butenafine)						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
NC	Xolegel®  (ketoconazole gel)						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

Under some plans, including plans that use an open or closed formulary, ciclopirox solution, Penlac and Vusion are subject to precertification.  If precertification requirements apply Aetna considers ciclopirox solution, Penlac and Vusion to be medically necessary for those members who meet ALL of the following precertification criteria:

For ciclopirox solution and Penlac

A. Diagnosis of onychomycosis confirmed by either a positive KOH stain (potassium hydroxide), positive PAS stain (para-aminosalicylic acid), or positive fungal culture within last 6 months

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 indicated for onychomycosis  OR
• Intolerance to one systemic (oral) alternative indicated for onychomycosis OR
• Failure of an adequate trial of six weeks of one systemic (oral) alternative indicated for onychomycosis  OR
• Presence of hepatic dysfunction or increased risk for liver disease OR
• Member is female and is pregnant or breastfeeding OR
• 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


2. Medical Exception Criteria

Loprox, Ertaczo, Exelderm, Extina, Halotin, Lamisil spray, Lotrisone, Mentax, Mycostatin, Naftin, Oxistat, Vusion and Xolegel  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 Loprox, Ertaczo, Exelderm, Extina, Halotin, Lamisil spray, Lotrisone, Mentax, Mycostatin, Naftin, Oxistat, Vusion and Xolegel to be medically necessary for those members who meet any of the following criteria:

For  Loprox, Ertaczo, Exelderm, Extina, Halotin, Lamisil spray, Lotrisone, Mycostatin, Naftin, Oxistat and Xolegel

A.  A documented:

• Contraindication to one preferred alternative indicated for the member's condition OR
• Intolerance to one preferred alternative indicated for the member's condition OR
• Allergy to one preferred alternative indicated for the member's condition  OR
• Failure of an adequate trial of two weeks of one preferred alternative indicated for the member's condition.

For Mentax

A documented:

• Contraindication to one of the following preferred alternatives indicated for the member's condition: ciclopirox, econazole or ketoconazole OR
• Intolerance to one of the following preferred alternatives indicated for the member's condition: ciclopirox, econazole or ketoconazole OR
• Allergy to one of the following preferred alternatives indicated for the member's condition: ciclopirox, econazole or ketoconazole OR
• Failure of an adequate trial of two weeks of one of the following preferred alternatives indicated for the member's condition: ciclopirox, econazole or ketoconazole

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 within last 6 months

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 indicated for onychomycosis   OR
• Intolerance to one systemic (oral) alternative indicated for onychomycosis OR
• Failure of an adequate trial of six weeks of one systemic (oral) alternative indicated for onychomycosis OR
• Presence of hepatic dysfunction or increased risk for liver disease OR
• Member is female and is pregnant or breastfeeding OR
• Member is < 12 yrs of age

AND

C. Member is NOT receiving a systemic (oral) antifungal agent for onychomycosis at the same time.

AND

D. A documented:

• Contraindication to the generic equivalent, ciclopirox solution OR
• Intolerance to the generic equivalent, ciclopirox solution OR
• Allergy to the generic equivalent, ciclopirox solution OR
• Failure of an adequate trial of two months of the generic equivalent, ciclopirox solution.
  

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 5 years of age

AND

C. A documented:

• Contraindication to one preferred antifungal alternative OR
• Intolerance to one preferred antifungal alternative OR
• Allergy to one preferred antifungal alternative OR
• Failure of an adequate trial of six weeks of one preferred antifungal alternative
  

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. Gupta AK, Einarson TR, Summerbell RC, Shear NH. An overview of topical antifungal therapy in dermatomycoses. Drugs 1998;55:645-74
8. Bell-Syer SE, et.al. Oral treatments for fungal infections of the skin of the foot. Cochrane Database Syst Rev. 2002; (2): CD003584.
9. 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.
10. Crawford F, Young P, Godfrey C, et al.  Oral treatment s for toenail onychomycosis. Arch Dermatol.  2002;138:811-16.
11. Darkes MJ, et. al. Terbinafine: a review of its use in onychomycosis in adults. Am J Clin Dermatol. 2003; 4(1): 39-65. Review.
12. 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
13. Gilbert DN, Moellering RC, Sande MA, eds.  The Sanford Guide to Antimicrobial Therapy 2003.  Antimicrobial Therapy Inc. Hyde Park, VT, 2003.
14. Gupta AK - Non-dermatophyte onychomycosis.Dermatol  Clin. 2003; 21(2): 257-68.
15. Gupta AK, Cooper EA, Lynde CW The efficacy and safety of terbinafine in children. Dermatol Clin. 2003 Jul; 21(3): 511-20.
16. Tosti A and Piraccini BM. Treatment of common nail disorders. Dermatol Clin 2000;18(2):339-48.
17. 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.
18. Niewerth M and Korting HC. Management of onychomycoses. Drugs 1999;58(2):283-96.
19. Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer: the first prescription topical therapy for onychomycosis. J Am Acad Dermatol 2000;43:570-80.
20. 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.
21. 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.

January 30, 2009