ADBRY (tralokinumab-ldrm)

ADBRY (tralokinumab-ldrm)

Self-Administration - subcutaneous injection

Diagnosis considered for coverage: 

• Atopic Dermatitis: Indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years 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.

Coverage Criteria:

For diagnosis of atopic dermatitis:

• Diagnosis of moderate to severe atopic dermatitis, AND
• Patient is 12 years of age or older, AND
• Prescribed by or in consultation with a dermatologist or an allergist/immunologist, AND
• One of the following: 
  • Involvement of at least 10% body surface area (BSA) 
  • SCORing Atopic Dermatitis (SCORAD) index value of at least 25, AND 
• Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to at least ONE of the following:
  • Medium or higher potency topical corticosteroid
  • Pimecrolimus cream
  • Tacrolimus ointment
  • Eucrisa (crisaborole) ointment

Reauthorization Criteria:

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 

Dosing:

• An initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week.
• After 16 weeks of treatment, for patients with body weight below 100 kg who achieve clear or almost clear skin, a dosage of 300 mg every 4 weeks may be considered.
   

Coverage Duration: 

• Initial: 6 months
• Reauthorization: 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• 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. 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. 

Policy Updates:

• 5/17/2022 – New policy approved by P&T.
• 06/01/2024 – Policy updated. (P&T, 05/21/2024).

References:

1. Adbry Prescribing Information. Leo Pharma Inc. Madison, NJ. November 2022. 
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; Epub ahead of print. 
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.