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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
DESCRIPTIONZyclara (imiquimod) is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses of the full face or balding scalp in immunocompetent adults, and it is indicated for the topical treatment of external genital and perianal warts in patients 12 years of age or older.
Zyclara will be approved when all of the following are met:
1. ONE of the following:
a. The patient has a diagnosis of actinic keratosis AND
2. ONE of the following:
a. The quantity prescribed does not exceed the set quantity and duration for the indication:
i. Actinic keratosis: 56 packets, two 7.5 gm pumps, or one 15 gm pump over 6 weeks
POLICY EXCEPTIONSZyclara prior authorization is not required for Federal Employee Program (FEP) and State Health Plan members.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
01/01/2014: New policy added.
07/22/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number L.5.01.484 added. Investigative definition updated in Policy Guidelines section.
08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
SOURCE(S)Zyclara® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.