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Generic name |
upadacitinib |
|
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Strength & form |
15 mg, 30 mg extended release tablets |
Special Authority criteria |
Approval period |
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InitialFor 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:
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 Please note that upadacitinib 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 |
6 months |
RenewalsPatient must attain and maintain beneficial clinical effect, defined as a 75% or greater improvement from 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 Please note that upadacitinib 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 |
1 year |
EASI score and vIGA-AD score must be calculated within the 3-month period immediately preceding the Special Authority request