Limited coverage criteria – lebrikizumab

Generic name

lebrikizumab

Strength & form

250 mg/2 mL pre-filled syringe
250 mg/2 mL pre-filled pen

Initial

For the treatment of patients 12 years and older with moderate to severe atopic dermatitis (AD) when ALL of the following criteria are met:

• Patient has had treatment failure despite an adequate trial of the following therapies:
  • Maximally tolerated medical topical therapies for AD combined with phototherapy (where available), and
  • Maximally tolerated medical topical therapies for AD combined with at least 1 of the 4 systemic immunomodulators (methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine)

AND

• Patient has an Eczema Area and Severity Index (EASI)¹ score of 16 or higher AND a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)¹ score of 3 or higher

AND

• Special Authority is requested by a dermatologist, allergist, or clinical immunologist who has expertise in the management of moderate to severe AD

6 months

Renewal

• Patient must attain and maintain beneficial clinical effect, defined as a 75% or greater improvement from the baseline in the EASI score (EASI-75)¹

AND

• Special Authority must be requested by a dermatologist, allergist, or clinical immunologist who has expertise in the management of moderate to severe AD