Aldara & Zyclara - Net Results Formulary

Restricted Product(s)

• Aldara® 5% (imiquimod) 
• Imiquimod 5% (generic Aldara® ) 
• Imiquimod 3.75% (generic ZyclaraTM) 
• ZyclaraTM 3.75% (imiquimod)

FDA Indication(s)

• Aldara 5% 
  • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults. 
  • Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults; maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. 
  • External genital and perianal warts/condyloma acuminata (EGW) in patients 12 years old or older. 
• Zyclara 3.75% 
  • Clinically typical, nonhyperkeratotic, visible or palpable actinic keratoses (AK) on the full face or balding scalp in immunocompetent adults 
  • External genital and perianal warts/condyloma acuminata (EGW) in patients 12 years old or older

Criteria for Approval of Restricted Product(s)

1. The patient has a normally functioning immune system (immunocompetent); AND 
2. If the request is for Aldara or generic imiquimod 5%: 
   1. The patient is 18 years of age or older; AND 
      1. The patient is using for clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp; AND 
      2. 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); OR 
   2. The patient is 12 year of age or older; AND 
      1. The patient is using for external genital and perianal warts/condyloma acuminata; AND 
      2. The patient will NOT be using more than 12 packets per month; AND 
   3. Patients requesting brand name Aldara have tried and failed or has a clinical contraindication/intolerance to generic imiquimod 5% (generic Aldara); AND
3. If the request is for Zyclara 3.75% or generic imiquimod 3.75%: 
   1. The patient is 18 years of age or older; AND 
      1. The patient is using for clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp; OR 
   2. The patient is 12 years of age or older; AND 
      1. The patient is using for external genital and perianal warts/condyloma acuminata; AND 
   3. Patients requesting brand name Zyclara 3.75% have tried and failed or have a clinical contraindication/intolerance to generic imiquimod 5% (generic Aldara); AND 
4. For products that require Medical Necessity PA, refer to the Medical Necessity PA UM Criteria. 

Duration of Approval:
Aldara and generic imiquimod 5%: 16 weeks
Zyclara and generic imiquimod 3.75%: 8 weeks

Quantity limit Exception Criteria

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 and generic imiquimod 3.75%: 8 weeks

References

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

Policy Implementation/Update Information

Feb 2022: Criteria update: Annual criteria review. No changes to policy.
Oct 2021: Criteria change: Added Zyclara 3.75% and generic to policy.
Aug 2020: Annual criteria review. Reformatted criteria. No changes to policy.
Aug 2017: Simplified language relative to immunocompetent patients
May 2017: Reformatted criteria
Feb 2017: Revised Aldara and generic imiquimod approval lengths
Jan 2016: Policy Originated