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New HTA Decisions in Germany
December 2021
Drug name
RINVOQ® (upadacitinib)
Company
AbbVie Deutschland GmbH & Co. KG
Decision date
01/12/2021
Therapeutic area
Skin conditions
Therapeutic sub area
Skin conditions: general and other
G-BA decision date
15/02/2022
Orphan Drug?
No
Decision
Considerable additional benefit
Indication
Males and females with moderate to severe atopic dermatitis for which systemic therapy is an option and 30mg is the appropriate dose. Appropriate comparator therapy: Dupilumab (possibly in combination with topical corticosteroids and/or topical calcineurin inhibitors).
Decision
No additional benefit
Indication
Adults with moderate to severe atopic dermatitis for which systemic therapy is an option and 15mg is the appropriate dose. Appropriate comparator therapy: Dupilumab (possibly in combination with topical corticosteroids and/or topical calcineurin inhibitors).
Decision
No additional benefit
Indication
Adolescents from 12-17 years with moderate to severe atopic dermatitis for which systemic therapy is an option. Appropriate comparator therapy: Dupilumab (possibly in combination with topical corticosteroids and/or topical calcineurin inhibitors).
Decision Detail
Main study: Heads-Up, Measure-Up 1, Measure-Up 2 and AD-Up. Main driver of decision: There were both positive and negative effects of upadacitinib for indication 1. A considerable advantage, compared to the ACT, was shown for the endpoints remission and pruritus in both male and female subgroups. There were also positive effects for the outcomes patient-reported symptoms in females, and patient-specific directed symptoms in males. No data was available for the assessment of indication 2; there was no suitable data presented for indication 3, as a transfer of results from adults to adolescents was not possible.
Summary
IQWIG concluded that there was a considerable added benefit for indication 1 and no added benefit for indications 2 and 3.