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Limited Coverage Drugs – abrocitinib

Last updated on September 27, 2024

 

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Generic name

abrocitinib

Strength & form

50 mg, 100 mg, and 200 mg tablets

Special Authority criteria

Approval period

Initial

For the treatment of patients 12 years of age and older with moderate to severe atopic dermatitis (AD) if 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 2 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

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

6 months

Renewals

  • 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

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

1 year

Practitioner exemptions

  • None

Special notes

  • 1EASI score and vIGA score must be calculated within the 3-month period immediately preceding the special authority request
  • Please note that abrocitinib will not be covered for use in combination with any other immunomodulatory agents (including biologics) or other JAK inhibitor treatment for moderate to severe AD

Special Authority request form(s)