Efudex (Fluorouracil) 5% cream — Blue Cross Blue Shield of Illinois

Preferred products

• generic imiquimod 5% cream
• fluorouracil solution

Initial criteria

• 1. If the patient has an FDA labeled indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication for the requested agent OR (B) There is support for using the requested agent for the patient’s age for the requested indication
• 2. ONE of the following diagnostic and product matches must apply:
• A. BOTH of the following: (1) The patient has a diagnosis of actinic (solar) keratoses of the face and/or scalp AND (2) The requested agent is diclofenac 3% gel, Carac (Fluorouracil) 0.5% cream, Efudex (Fluorouracil) 5% cream, Fluoroplex, Tolak, imiquimod 5%, Zyclara (imiquimod) 3.75% cream, Zyclara 2.5% cream, or Klisyri
• B. BOTH of the following: (1) The patient has a diagnosis of actinic (solar) keratoses of the trunk and/or extremities AND (2) The requested agent is diclofenac 3% gel, Efudex (Fluorouracil) 5% cream, or Fluoroplex
• C. BOTH of the following: (1) The patient has a diagnosis of superficial basal cell carcinoma AND (2) The requested agent is imiquimod 5% or Efudex (Fluorouracil) 5% cream
• D. BOTH of the following: (1) The patient has a diagnosis of external genital and/or perianal warts (EGW) / condyloma acuminata AND (2) The requested agent is imiquimod 5% or Zyclara (imiquimod) 3.75% cream

Reauthorization criteria

• For a diagnosis of actinic keratoses or superficial basal cell carcinoma:
• • The patient is currently being treated with the requested agent and is stable on therapy [chart notes required] OR
• • The patient has tried and had an inadequate response to generic imiquimod 5% cream or fluorouracil solution [chart notes required] OR
• • Generic imiquimod 5% cream or fluorouracil solution was discontinued due to lack of efficacy, adverse event, or diminished effect [chart notes required] OR
• • The patient has an intolerance or hypersensitivity to generic imiquimod 5% cream or fluorouracil solution [chart notes required] OR
• • The patient has an FDA labeled contraindication to both generic imiquimod 5% cream and fluorouracil solution [chart notes required] OR
• • Generic imiquimod 5% cream or fluorouracil solution is expected to be ineffective, inappropriate, or unsafe for the patient based on known characteristics or would worsen a comorbidity or prevent adherence [chart notes required] OR
• • Generic imiquimod 5% cream or fluorouracil solution is not in the best interest of the patient based on medical necessity [chart notes required] OR
• • The patient has tried another prescription drug in the same pharmacologic class as generic imiquimod 5% cream or fluorouracil solution and that drug was discontinued for lack of efficacy or adverse event [chart notes required]
• For a diagnosis of external genital and/or perianal warts (EGW) / condyloma acuminata:
• • The patient is currently being treated with the requested agent and is stable on therapy [chart notes required] OR
• • The patient has tried and had an inadequate response to generic imiquimod 5% cream [chart notes required]

Approval duration

180 days