CSL Behring’s Garadacimab Receives Positive IQWiG Assessment in Germany
CSL Behring has achieved a significant milestone with the German Institute for Quality and Efficiency in Health Care (IQWiG) issuing a positive benefit assessment for garadacimab, its once-monthly prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 years and older.
IQWiG's evaluation, based on a methodologically sound indirect comparison using placebo as a common comparator, concluded that garadacimab offers a "hint of considerable additional benefit" in reducing monthly HAE attack rates. This marks a precedent in the AMNOG process since its inception in 2011.
The assessment also noted minor additional benefits in general health status (EQ-VAS) and disease-specific quality of life (AE-QoL). CSL Behring's submission included data from the VANGUARD study, comparing garadacimab with appropriate comparative therapies defined by the Federal Joint Committee (G-BA), all incorporating a 24-week placebo-controlled treatment phase.
Verena Donatz, Market Access Head Germany at CSL Behring, emphasized the significance of this outcome, highlighting it as a strong validation of their evidence strategy and commitment to providing innovative treatment options.
The final decision by the G-BA is anticipated in late August 2025. CSL Behring remains engaged with stakeholders to facilitate access to garadacimab for eligible patients across Germany.
