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New HTA Decisions in Germany
December 2021
Drug name
BIMZELX® (bimekizumab)
Company
UCB Pharma GmbH
Decision date
15/12/2021
Therapeutic area
Skin conditions
Therapeutic sub area
Psoriasis
G-BA decision date
01/03/2022
Orphan Drug?
No
Decision
Minor additional benefit
Indication
Adult patients with moderate to severe plaque psoriasis, for whom the conventional therapy, systemic therapy, is not an option. Appropriate comparator therapy: Adalimumab, or guselkumab, or ixekizumab, or secukinumab.
Decision
No additional benefit
Indication
Adult patients with moderate to severe plaque psoriasis, who have had an inadequate response to, or have not tolerated systemic therapy. Appropriate comparator therapy: Adalimumab, or brodalumab, or guselkumab, or infliximab, or ixekizumab, or risankizumab, or secukinumab, or ustekinumab.
Decision Detail
Main studies: BE SURE and BE RADIANT Main drivers of decision: For indication 1 there was evidence of a minor added benefit for the endpoints remission PASI 100 and PSD flaking, compared to the ACT. For the endpoint SAE, there was evidence of a greater harm, but the extent of this was not quantifiable. For indication 2 there was evidence of a minor added benefit of bimekizumab for the endpoints PSD flaking and PSD reddening. However, there was evidence of a greater harm of considerable extent for the endpoint fungal infection.
Summary
IQWIG concluded that were was a minor added benefit for indication 1, and no added benefit for indication 2.