Under some plans, including plans that use an open or closed formulary, ciclopirox,Penlac is subject to precertification. If precertification requirements apply Aetna considers ciclopirox, Penlac to be medically necessary for those members who meet ALL of the following precertification criteria:
A. Diagnosis of onychomycosis confirmed by either a positive KOH stain (potassium hydroxide), positive PAS stain (para-aminosalicylic acid), or positive fungal culture
NOTE: This positive test should be recent (within the last 3 -6months or so) and associated with the current infection.
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 (e.g., 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(for example, has a history of alcohol abuse or a history of hepatitis) OR
Member is female and is pregnant and/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.
Medical Exception Criteria
Penlac is currently listed on the Aetna Formulary Exclusions List.* Therefore, Penlac is excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted. Aetna considers Penlac to be medically necessary for those members who meet ALL of the following criteria:
A. Diagnosis of onychomycosis confirmed by either a positive KOH stain (potassium hydroxide), positive PAS stain (para-aminosalicylic acid), or positive fungal culture
NOTE: This positive test should be recent (within the last 3 -6months or so) and associated with the current infection.
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 (e.g., 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(for example, has a history of alcohol abuse or a history of hepatitis) OR
Member is female and is pregnant and/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.
Special Notes:
PENLAC is a nail lacquer/topical solution for use on fingernails and toenails and the immediately adjacent skin. It should be used as a part of a comprehensive treatment program for mild to moderate onychomycosis; this treatment program may include removal of unattached, infected nails as frequently as monthly.
Because PENLAC does not remain in the nails for any significant length of time after therapy is discontinued, there is NO limiting time period after use of PENLAC before a member can receive another antifungal for onychomycosis - There is NOT a required waiting period as there is with Lamisil and Sporanox.
PENLAC has NOT been studied in patients who: are HIV positive, are insulin dependent diabetics or have diabetic neuropathy, have epilepsy requiring medication, have received an organ transplant, or have any history of immunosuppression (have extensive skin disease like seborrheic dermatitis or fungal infections, recent or recurring herpes zoster or persistent herpes simplex).
Liver Disease
In patients with active, chronic or pre-existing liver disease (such as Hepatitis B or C) and/or have elevated abnormal liver enzymes, or experienced liver toxicity with other drugs, there is a greater risk for more severe hepatic events and/or outcomes when taking oral antifungal therapy, such as itraconazole or terbinafine and/or other azole antifungals, and oral antifungal therapy is not recommended. Prior to administration of oral antifungal therapy, presence of liver disease should be assessed; pretreatment determination of serum concentrations of ALT (SGPT) and AST (SGOT) is advised for all patients. Oral antifungal therapy should be discontinued if biochemical or clinical signs of liver injury develop during therapy.
Place of Service:
Outpatient
The above policy is based on the following references:
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.
Penlac Product Information. Aventis Pharmaceuticals, Inc, Kansas City, MO, and Dermik Laboratories, Inc, Collegeville, PA. August 2000.
GuptaAK, Fleckman P, Baran R. Ciclopirox nail lacquer: the first prescription topical therapy for onychomycosis. J Am Acad Dermatol 2000;43:570-80.
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2005.
USPDI Drug Information for the HealthCare Professional(online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2005.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2005.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2005.
Copyright 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.
*P = Preferred
FE = Formulary Excluded
NP = Nonpreferred
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.
Close Window
