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New HTA Decisions in Germany
March 2021
Drug name
TALTZ® (ixekizumab)
Company
Lilly Deutschland GmbH
Decision date
21/01/2021
Therapeutic area
Skin conditions
Therapeutic sub area
Psoriasis
G-BA decision date
21/01/2021
Orphan Drug?
No
Decision
No additional benefit
Indication
Children and adolescents from 6 years of age with a body weight of at least 25kg who have moderate to severe plaque psoriasis and are eligible for systemic therapy. Main comparator: Adalimumab or etanercept or ustekinumab.
Decision Detail
Main studies: IXORA-S and IXORA-PEDS. Main driver of decision: Due to a lack of studies involving children and adolescents with a duration of at least 24 weeks (during IXORA-PEDS data comparing the drug and comparator were only available for 12 weeks), the company also utilised data from the adult study IXORA-S. However, the company's approach to information procurement, processing of results and the transfer of the additional benefit was deemed incomplete and inconsistent, with IQWiG concluding that there was no interpretable data available.
Summary
IQWiG concluded that there was insufficient evidence presented to assess added benefit.