Zyclara (imiquimod) 3.75% cream — Blue Cross Blue Shield of New Mexico

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 AND
• 2. ONE of the following: 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 OR 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 OR 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 OR 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
• 3. ONE of the following: A. BOTH of the following: 1. ONE of the following: A. The prescriber has stated that the patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR B. The prescriber has submitted documentation that the patient has stage four advanced, metastatic cancer and the requested agent is being used to treat an associated condition related to stage four advanced metastatic cancer [chart notes required] AND 2. The use of the requested agent is consistent with best practices for treatment of stage four advanced, metastatic cancer or associated condition and approved by FDA OR
• B. For diagnosis of actinic keratoses or superficial basal cell carcinoma, ONE of the following: 1. The patient is currently being treated with and stable on the requested agent [chart notes required] OR 2. Tried and had inadequate response to generic imiquimod 5% cream or fluorouracil solution [chart notes required] OR 3. Discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR 4. Intolerance or hypersensitivity to generic imiquimod 5% cream or fluorouracil solution [chart notes required] OR 5. FDA labeled contraindication to both generic imiquimod 5% cream and fluorouracil solution [chart notes required] OR 6. Expected ineffective or inappropriate therapy based on clinical characteristics or potential harm [chart notes required] OR 7. Not in the best interest of the patient based on medical necessity [chart notes required] OR 8. Tried another prescription drug in same class or mechanism and discontinued for lack of efficacy/effectiveness or adverse event [chart notes required] OR
• C. For diagnosis of external genital warts and/or perianal warts (EGW) / condyloma acuminata, ONE of the following: 1. Currently being treated with and stable on the requested agent [chart notes required] OR 2. Tried and had inadequate response to generic imiquimod 5% cream [chart notes required]

Approval duration

180 days