Adbry (tralokinumab-ldrm) — Medica

Initial criteria

• age ≥ 12 years
• atopic dermatitis involvement estimated to be ≥ 10% of body surface area according to the prescriber
• patient has tried at least one medium-, medium-high, high-, and/or super-high-potency prescription topical corticosteroid
• topical corticosteroid was applied daily for at least 28 consecutive days
• inadequate efficacy demonstrated with this topical corticosteroid therapy according to the prescriber
• medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist

Reauthorization criteria

• patient has already received at least 4 months of therapy with Adbry
• patient has responded to therapy as determined by the prescriber (e.g., marked improvements in erythema, induration/papulation/edema, excoriations, and lichenification; reduced pruritus; decreased requirement for other topical or systemic therapies; reduced body surface area affected with atopic dermatitis; or other observed responses)

Approval duration

initial: 4 months; reauthorization: 1 year