WHA

Zyclara (imiquimod)

Indications for Prior Authorization

Zyclara (imiquimod)
  • For diagnosis of Actinic Keratosis (AK)
    Indicated for the topical treatment of clinically typical, visible, or palpable AK of the face or balding scalp in immunocompetent adults.

  • For diagnosis of External Genital and Perianal Warts (EGW)
    Indicated for the topical treatment of EGW in immunocompetent patients 12 years of age or older.

Criteria

Zyclara 2.5% cream, Brand Zyclara 3.75% cream, Generic imiquimod 3.75% cream

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication [A]
    • AND
  • Trial and failure (of a minimum 30-day supply), or intolerance of generic imiquimod 5%

  • Guideline ID
    GL-376240

  • Formulary
    Premium

  • Effective date
    Dec 1, 2025

  • P&T approval date
    Sep 18, 2019

P & T Revisions

2025-08-28, 2024-09-17, 2023-09-22, 2022-09-30, 2021-10-30, 2021-07-13, 2020-08-27, 2019-08-08

  1. Zyclara prescribing information. Bausch Health US, LLC. Bridgewater, NJ. September 2024.
  2. Eisen DB, Asgari MM, Bennett DD, et al. Guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2021;85(4):e209-e233. doi:10.1016/j.jaad.2021.02.082.
  1. Both dosage strengths (i.e., 2.5% and 3.75%) are indicated for the topical treatment of AK. Only the 3.75% strength of Zyclara is indicated for EGW. [1]
  • 2025-08-28: Annual Review 2025 - No criteria changes. Background updates.
  • 2024-09-17: 2024 UM Annual Review. No changes. Background updates
  • 2023-09-22: 2023 UM Annual Review. Added criteria for FDA approved indication
  • 2022-09-30: 2022 Annual Review.
  • 2021-10-30: Background updates.
  • 2021-07-13: new target generic imiquimod cream 3.75% added
  • 2020-08-27: Annual Review: added minimum day supply for T/F/I and updated references
  • 2019-08-08: Per assignment grid: add new step through generic imiquimod 5%