WHA
 

Adquey (difamilast) - PA, NF

Indications for Prior Authorization

Adquey (difamilast)
  • For diagnosis of Atopic Dermatitis
    Indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.

Criteria

Adquey

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Atopic Dermatitis

  • Diagnosis of mild to moderate atopic dermatitis
    • AND
  • Patient is 2 years of age or older
    • AND
  • Prescribed by or in consultation with one of the following:
    • Dermatologist
    • Allergist/Immunologist
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to both of the following [2-3]:
    • Medium or higher potency topical corticosteroid
    • Generic topical calcineurin inhibitor (e.g., tacrolimus ointment)
    AND
  • Not used in combination with other nonsteroidal topical agents or systemic therapies for atopic dermatitis [A]
Adquey

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Atopic Dermatitis

  • Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following [1-3]
    • Reduction in body surface area involvement from baseline
    • Reduction in pruritus severity from baseline
    • Improvement in quality of life from baseline
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to both of the following [2-3]:
    • Medium or higher potency topical corticosteroid
    • Generic topical calcineurin inhibitor (e.g., tacrolimus ointment)
    AND
  • Not used in combination with other nonsteroidal topical agents or systemic therapies for atopic dermatitis [A]
Adquey

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Atopic Dermatitis

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of mild to moderate atopic dermatitis
    • AND
  • Patient is 2 years of age or older
    • AND
  • Prescribed by or in consultation with one of the following:
    • Dermatologist
    • Allergist/Immunologist
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to both of the following [2-3]:
    • Medium or higher potency topical corticosteroid
    • Generic topical calcineurin inhibitor (e.g., tacrolimus ointment)
    AND
  • Not used in combination with other nonsteroidal topical agents or systemic therapies for atopic dermatitis [A]

  • Guideline ID
    GL-742198

  • Formulary
    Premium

  • Effective date
    Nov 1, 2026

  • P&T approval date
    Oct 21, 2026

P & T Revisions

2026-10-26, 2026-10-08, 2025-11-06, 2024-12-05, 2023-11-01, 2023-08-18, 2022-11-02, 2022-08-24, 2021-10-25, 2021-09-30, 2021-08-24, 2020-10-26, 2020-08-21, 2020-03-31, 2019-09-24, 2019-08-22

  1. Adquey Prescribing Information. Acrotech Biopharma, Inc . East Windsor, NJ. February 2026.
  2. Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.
  3. Davis DMR, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in pediatric patients. Published online April 7, 2026. https://www.jaad.org/action/showPdf?pii=S0190-9622%2826%2900343-9.
  1. Concomitant treatment for atopic dermatitis was prohibited in the clinical trials [1]. Examples of nonsteroidal topical agents include, but are not limited to, crisaborole, roflumilast, ruxolitinib, and tapinarof. Examples of systemic therapies for atopic dermatitis include, but are not limited to, abrocitinib, dupilumab, lebrikizumab-lbkz, nemolizumab-ilto, tralokizumab-ldrm, and upadacitinib.
  • 2026-10-26: New program
  • 2026-10-08: New program
  • 2025-11-06: 2025 Annual Review. No criteria changes. Updated references.
  • 2024-12-05: 2024 Annual Review. No criteria changes.
  • 2023-11-01: Annual Review, no changes.
  • 2023-08-18: 2024 Medicare Implementation - No Changes
  • 2022-11-02: 2022 Annual Review
  • 2022-08-24: 2023 Guideline Loading created from HPMS Submission file
  • 2021-10-25: Annual Review - No criteria changes
  • 2021-09-30: 2022 formulary note addition - no changes to criteria
  • 2021-08-24: 2022 Medicare Implementation - No Changes
  • 2020-10-26: No changes to clinical criteria annual review
  • 2020-08-21: 2021 Guideline Loading created from HPMS Submission file
  • 2020-03-31: Program Update
  • 2019-09-24: updated references removed elidel reference no longer on GL
  • 2019-08-22: 2020 Migration Upload - formulary strategy update