Aldara and Zyclara - NC Standard

Restriction applies to brand and generic products

• Aldara 5% (imiquimod) 
• Zyclara 2.5% (imiquimod)
• Zyclara 3.75% (imiquimod) 

• Aldara 5%
  • For the treatment of clinically typical, nonhyperkeratotic, nonhypertrophic visible or palpable actinic keratoses on the face or balding scalp in immunocompetent adults.
  • For the treatment of biopsy-confirmed, primary superficial basal cell carcinoma in immunocompetent adults with a maximum tumor diameter of 2 cm located on the trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.
  • For the treatment of external genital and perianal warts (condyloma acuminate) in patients 12 years old or older.
• Zyclara 2.5%
  • For the treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults.
• Zyclara 3.75%
  • For the treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults
  • For the treatment of external genital and perianal warts/condyloma acuminata (EGW) in patients 12 years or older.

1. ONE of the following:
   1. The patient is using for clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp; AND
      1. The patient is 18 years of age or older; AND
      2. If requesting Aldara 5%, the patient will NOT be using more than 12 packets per month; OR
   2. The patient is using for external genital and perianal warts / condyloma acuminata; AND
      1. The patient is 12 years of age or older; AND
      2. The request is for Aldara 5% or Zyclara 3.75%; AND
      3. If requesting Aldara 5%, the patient will NOT be using more than 12 packets per month; OR
   3. The patient is using for biopsy-confirmed, primary superficial basal cell carcinoma (sBCC); AND
      1. The patient is 18 years of age or older; AND 
      2. The request is for Aldara 5%; AND
2. The patient has a normally functioning immune system (immunocompetent); AND
3. Formularies which exclude (Non-Formulary) the requested product are subject to Non-formulary Exception Criteria. 

Duration of Approval:

Aldara and generic imiquimod 5%: 16 weeks

Zyclara 2.5% and 3.75% and generic imiquimod 3.75%: 8 weeks

Quantity limitations apply to brand and associated generic products

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval:

Aldara and generic imiquimod 5%: 16 weeks

Zyclara 2.5% and 3.75% and generic imiquimod 3.75%: 8 weeks

All information referenced is from FDA package insert unless otherwise noted below.

April 2023: Criteria change: Created a NC Standard policy. Removed step through generic Aldara. Clarified quantity limitations.

Feb 2022: Criteria update: Annual criteria review. No changes to policy. Dec 2020: Criteria update: For Zyclara 2.5% cream, removed reference to “packets” and “15 gm pump bottle” since 2.5% cream is available only in 7.5 gm pump bottle. For Zyclara 3.75% cream, removed reference to “15 gm pump bottle” since this formulation is not available.

Aug 2020: Annual criteria review. Reformatted criteria. No changes to policy.

Sept 2018: Imiquimod 3.75% added to market.

Aug 2017: simplified language in regard to the immune function of patients.

May 2017: Reformatted criteria; adjusted approval lengths for Zyclara (extended to 8 weeks on all indications); clarified quantity limitations; added non-formulary exception language.

Feb 2017: Revised Aldara and generic imiquimod approval lengths.

Jan 2016: Policy Originated.