Under some plans, including plans that use an open or closed formulary, Kerol Redi-Cloths are subject to step-therapy. Aetna considers Kerol Redi-Cloths to be medically necessary for those members who meet the following step-therapy criteria:
A documented trial of one month of urea - a generic alternative on the Aetna Medicare Preferred Drug List.
If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section II below.)
Medical Exception Criteria
Carmol 40 gel and lotion, Cerovel, Gordons Urea, Hydro 40, Hylira, Kerafoam, Keralac, Keralyt, Kerol, Kerol Redi-Cloths, Lac-Hydrin 12%, Rinnovi Nail System, Salex, Umecta and Uralytic-2 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 benefits plans that use a closed formulary, unless a medical exception is granted. Aetna considers Carmol 40 gel and lotion, Cerovel, Gordons Urea, Hydro 40, Hylira, Kerafoam, Keralac, Keralyt, Kerol, Kerol Redi-Cloths, Lac-Hydrin 12%, Rinnovi Nail System, Salex, Umecta and Uralytic-2 to be medically necessary for those members who meet ANY of the following criteria:
For Carmol 40 gel and lotion, Cerovel, Gordons Urea, Hydro 40, Hylira, Kerafoam, Keralac, Kerol, Lac-Hydrin 12%, Rinnovi Nail System, Umecta and Uralytic-2
A. A documented:
Contraindication to one preferred alternative agent indicated for the member's condition OR
Intolerance to one preferred alternative agent indicated for the member's condition OR
Allergy to one preferred alternative agent indicated for the member's condition OR
Failure of an adequate trial of one month of one preferred alternative agent indicated for the member's condition
For Kerol Redi-Cloths
A. A documented:
Contraindication to the preferred generic alternative, urea OR
Intolerance to the preferred generic alternative, urea OR
Allergy to the preferred generic alternative, urea OR
Failure of an adequate trial of one month of the preferred generic alternative, urea
For Keralytand Salex
A. A documented:
Contraindication to a salicylic acid product OR
Intolerance to a salicylic acid product OR
Allergy to a salicylic acid product OR
Failure of an adequate trial of one month of a salicylic acid product
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, 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; 2003.
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, Bierman AS, et al. Potentially inappropriate medication use in the community-dwelling elderly.JAMA. 2001;286:2823-29.
Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: November 21, 2005).
Pigatto PD, Bigardi AD, Cannistraci C, et al: 10% urea cream (Laceran) for atopic dermatitis: a clinical and laboratory evaluation. J Dermatol Treat 1996; 7:171-175.
Andersson AC, Lindberg M, & Loden M: The effect of two urea-containing creams on dry, eczcematous skin in atopic patients. I. Expert, patient and instrumental evaluation. J Dermatol Treat 1999; 10:165-169.
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.
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