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New HTA Decisions in Germany
June 2020
Drug name
ESPEROCT® (turoctocog alfa pegol)
Company
Novo Nordisk Pharma
Decision date
04/11/2019
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood conditions
G-BA decision date
01/02/2020
Orphan Drug?
No
Decision
No additional benefit
Indication
Treatment and prophylaxis of bleeding in patients 12 years and older with Hemophilia A (congenital factor VIII defect) Main comparator therapy: recombinant or human plasma recovered coagulation factor VIII preparations
Decision Detail
Main study: Pathfinder 2 and 3 Main driver of decision: Both studies were non comparative studies and as such were not considered suitable for the derivation of an added benefit.
Summary
IQWIG concluded that based on a lack of direct comparative evidence, no added benefit could be shown for turoctocog alfa pegol over the comparator.