WHA

Adbry (tralokinumab-ldrm)

Indications for Prior Authorization

Adbry (tralokinumab-ldrm)
  • For diagnosis of Atopic Dermatitis
    Indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. May be used with or without topical corticosteroids.

Criteria

Adbry

*QL Override (For new starts only): Enter 2 PAs as follows: First PA: Approve with MDD = 0.29 & PTD = 6 syringes or 4 autoinjectors per 28 days for one month; Second PA: Approve 4 syringes or 2 autoinjectors per 28 days (no overrides needed) for the remaining 5 months. (Adbry is hard-coded with a quantity of 4 syringes per 28 days)

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months*
For diagnosis of Atopic Dermatitis

  • Diagnosis of moderate to severe atopic dermatitis
    • AND
  • One of the following:
    • Involvement of at least 10% body surface area (BSA)
    • SCORing Atopic Dermatitis (SCORAD) index value of at least 25 [A]
    AND
  • Patient is 12 years of age or older
    • AND
  • Prescribed by or in consultation with one of the following:
    • Dermatologist
    • Allergist/Immunologist
    AND
  • Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to ONE of the following:
    • Medium or higher potency topical corticosteroid
    • Generic topical calcineurin inhibitor (e.g., tacrolimus ointment)
    • Eucrisa (crisaborole) ointment
    • Opzelura (ruxolitinib) cream
    • Zoryve (roflumilast) 0.15% cream
Adbry

Prior Authorization (Reauthorization)

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

  • Patient demonstrates positive clinical response to therapy as evidenced by at least ONE of the following:
    • Reduction in body surface area involvement from baseline
    • Reduction in SCORing Atopic Dermatitis (SCORAD) index value from baseline [A]

  • Guideline ID
    GL-164731

  • Formulary
    Premium

  • Effective date
    Mar 1, 2025

  • P&T approval date
    Feb 17, 2022

P & T Revisions

2025-02-09, 2024-08-02, 2024-01-31, 2023-09-13, 2023-01-31, 2022-12-15, 2022-06-02, 2022-02-20

  1. Adbry Prescribing Information. Leo Pharma Inc. Madison, NJ. June 2024.
  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. European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Consensus report of the European Task Force on atopic dermatitis. Dermatology. 1993; 186:23-31.
  4. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet 2017; 389(10086)(suppl):2287-2303.
  5. Oranje AP. Practical issues on interpretation of scoring atopic dermatitis: SCORAD index, objective SCORAD, patient-oriented SCORAD and three-item severity score. Curr Probl Dermatol. 2011; 41:149-55.
  1. The Scoring Atopic Dermatitis (SCORAD) index is a clinical tool for assessing the severity of atopic dermatitis lesions based on affected body area and intensity of plaque characteristics. [3, 4] The extent and severity of AD over the body area (A) and the severity of 6 specific symptoms (erythema, edema/papulation, excoriations, lichenification, oozing/crusts, and dryness) (B) are assessed and scored by the Investigator. Subjective assessment of itch and sleeplessness is scored by the patient (C). The SCORAD score is a combined score (A/5 + 7B/2 + C) with a maximum of 103. Higher scores indicate greater severity/worsened state. A score of 25 to 50 indicates moderate disease severity and greater than 50 indicates severe disease. [5]
  • 2025-02-09: Addition of Opzelura and Zoryve 0.15% as additional preferred alternatives; updated verbiage for topical calcineurin inhibitors to "generic topical calcineurin inhibitor (e.g., tacrolimus ointment)"
  • 2024-08-02: Addition of new 300 mg strength; no criteria changes.
  • 2024-01-31: Updated indication and criteria to reflect approval for patients 12 years or older; Annual review - background updates
  • 2023-09-13: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-01-31: Annual review - no criteria changes; background updates
  • 2022-12-15: Update to QL Operational Note
  • 2022-06-02: Reduced embedded topical step from a trial of two agents to one
  • 2022-02-20: New program