Dupilumab Chronic Spontaneous Urticaria: G-BA Finds No Proven Added Benefit
November 6, 2026
The Gemeinsamer Bundesausschuss (G-BA), Germany’s Federal Joint Committee, has found that the added benefit of dupilumab chronic spontaneous urticaria treatment is not proven. The decision, dated 5 November 2026 and in force from the same day, covers adults and adolescents aged 12 and over whose urticaria responds insufficiently to H1 antihistamines and who have not yet received anti-IgE antibodies.
The decision amends Annex XII of the Arzneimittel-Richtlinie, Germany’s drug directive. It is the benefit assessment under Section 35a of Book V of the Social Code (SGB V) for a new indication that was authorised on 6 November 2025. The G-BA based its decision on a dossier from the manufacturer, the IQWiG dossier assessment, and the comments received in the written and oral hearing procedures.
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