Difamilast (Adquey) topical for atopic dermatitis
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Defines medical necessity, prior authorization, and coverage criteria for topical difamilast (Adquey) for members age 2 and older across QualChoice lines of business (Commercial, HIM/ICHRA, Medicaid). Affects providers requesting coverage or continuation of Adquey.
No material clinical or coverage changes in this revision.
Coverage Criteria for Difamilast (Adquey)
Initial Therapy — Covered when ALL of the following are met for Atopic Dermatitis (Initial Approval)
Covered when ALL of the following are met for Atopic Dermatitis (Initial Approval):
Illinois HIM requests: step therapy requirements do not apply per IL HB 5395 (see inline notes).
Continuation Therapy — Continuation of therapy covered when ALL of the following are met
Continuation of therapy covered when ALL of the following are met:
Refer to state-specific continuity of care addendums for CC.PHARM.03A and CC.PHARM.03B.
Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace/ICHRA), or CP.PMN.53 (Medicaid).
Initial Therapy Requirements
Initial therapy — Initial therapy criteria for atopic dermatitis
Initial therapy criteria for atopic dermatitis
Illinois HIM requests: step therapy requirements do not apply per IL HB 5395.
Initial therapy — Initial dosing for indicated condition
Initial dosing for indicated condition
Criteria for Continued Therapy
Continuation — Continued therapy criteria
Continued therapy criteria
Refer to state-specific continuity of care addendums for CC.PHARM.03A and CC.PHARM.03B.
Provider Requirements and Actions
Prior authorization required for Adquey
Prior authorization is required for Adquey (difamilast) and must include documentation demonstrating: a diagnosis of atopic dermatitis, member age ≥ 2 years, completion of the specified prior topical therapy trials (unless contraindicated), and that the requested dose does not exceed 60 grams per 30 days.
- Diagnosis of atopic dermatitis must be documented.
- Member age ≥ 2 years must be documented.
- Prior topical therapy trials as specified in the policy must be documented (see step therapy block).
- Requested dose must not exceed 60 g per 30 days.
Step therapy: required prior topical treatments
Approval requires documented failure of specified topical therapies: two separate 2-week trials of different generic medium to very high potency topical corticosteroids (different molecular identities) and a 2-week trial of topical tacrolimus, unless contraindicated or clinically significant adverse effects occurred.
- Two 2-week trials of generic medium to very high potency topical corticosteroids of different molecular identities (unless contraindicated).
- A 2-week trial of topical tacrolimus (unless contraindicated or adverse effects).
- Illinois HIM requests are exempt from these step therapy requirements per IL HB 5395 (effective 1/1/2026).
Step therapy absence (document note)
Some sections note no step therapy requirements; however, the policy’s initial approval criteria explicitly require specific topical therapy trials (see step therapy block) except where state law exempts HIM requests.
- The document contains a statement that no step therapy requirements are specified in certain sections, but initial approval criteria do include step therapy requirements (see policy I.A).
Supporting documentation required with PA requests
Providers must submit supporting clinical documentation with prior authorization requests, such as office chart notes, lab results, or other clinical information demonstrating the member has met all approval criteria.
- Include office chart notes documenting diagnosis, prior topical therapy trials (dates, agents, duration, response or adverse effects), and age.
- Include any relevant lab results or other clinical notes supporting contraindications to step agents when applicable.
Denial risk if documentation or criteria not met
Requests that do not include documentation showing the member meets approval criteria (e.g., diagnosis, required prior topical therapy trials, age) may be denied.
- Missing documentation of required 2-week trials of topical corticosteroids or topical tacrolimus may result in denial.
- Missing documentation of diagnosis or age may result in denial.
Prior authorization considerations (dosing & product availability)
Before approval, providers should follow labeled dosing instructions and note product availability when submitting requests: apply a thin layer to affected areas twice daily for mild-to-moderate atopic dermatitis; Adquey ointment 1% is available in 27 g and 85 g packages.
- Dosing: apply a thin layer to the affected areas twice daily for mild-to-moderate atopic dermatitis.
- Product availability: Ointment (1%) in 27 g and 85 g package sizes.
Supporting references for coverage decisions
Use the policy references and prescribing information to support coverage decisions and to document rationale when submitting requests.
- Referenced materials include Adquey Prescribing Information and published atopic dermatitis guidelines cited in the policy.
Medicaid coverage precedence
For Medicaid members, state Medicaid coverage provisions override this clinical policy when there is a conflict; consult the state Medicaid manual for applicable coverage rules.
- If state Medicaid provisions differ from this policy, the state provisions take precedence for Medicaid members.
Step Therapy Requirements
| Step | Requirement | Duration/Notes |
|---|---|---|
| 1 | Failure of a 2-week trial of two generic medium to very high potency topical corticosteroids of different molecular identities (unless contraindicated, e.g., face, neck, intertriginous areas, or clinically significant adverse effects). | 2 weeks per corticosteroid; Illinois HIM requests exempt from step therapy per IL HB 5395 (effective 1/1/2026). |
| 2 | Failure of a 2-week trial of topical tacrolimus (unless contraindicated or clinically significant adverse effects are experienced). | 2 weeks; note topical tacrolimus may require prior authorization. |
Coding and Quantity Limits
Quantity Limits and Packaging
Background and Drug Information
Difamilast (Adquey) is a topical phosphodiesterase‑4 (PDE‑4) inhibitor indicated for the treatment of mild to moderate atopic dermatitis in adults and pediatric patients aged ≥ 2 years. The product is supplied as a 1% ointment and is available in package sizes of 27 g and 85 g. For mild‑to‑moderate disease, the prescribing information recommends to apply a thin layer to affected areas twice daily.
Definitions and Dosing
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