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New HTA Decisions in Germany
December 2021
Drug name
EVRENZO® (roxadustat)
Company
Astellas Pharma GmbH
Decision date
15/12/2021
Therapeutic area
Kidney conditions
Therapeutic sub area
Chronic kidney disease
G-BA decision date
01/03/2022
Orphan Drug?
No
Decision
No additional benefit
Indication
Adults with symptomatic anaemia in chronic kidney disease who have not previously been treated with an erythropoiesis-stimulating agent (ESA), or who are being switched from an ESA; of which adults only stably pre-treated with an ESA are suitable for switching. Appropriate comparator therapy: ESA
Decision Detail
Main driver of decision: There were no relevant RCTs identified for the benefit assessment of roxadustat in comparison with the ACT. Therefore, no suitable data was available for the benefit assessment.
Summary
IQWIG concluded that there was no added benefit.