Pharmacy Prior Authorization Criteria

Zyclara (imiquimod)

Indications for Prior Authorization

Zyclara (imiquimod)

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

• For diagnosis of External Genital Warts
  Indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years 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
AND
• Trial and failure (of a minimum 30-day supply), or intolerance of generic imiquimod 5%

P & T Revisions

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

References

1. Zyclara prescribing information. Bausch Health US, LLC. Bridgewater, NJ. June 2020.
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.

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Revision History

• 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%

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