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New HTA Decisions in Germany
June 2020
Drug name
ULTOMIRIS® (ravulizumab)
Company
Alexion Pharma Germany
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
Adults with paroxysmal hemoglobinuria with hemolysis together with 1 or more clinical symptoms as evidence of high disease activity Main comparator: Eculizumab
Decision
No additional benefit
Indication
Adults with paroxysmal hemoglobinuria who are clinically stable after being treated at least once with eculizumab during the past 6 months Main comparator: Eculizumab
Decision Detail
Main study: Study 301 and 302 Main driver of decision: The studies provided show neither advantages or disadvantages of treatment with ravulizumab as compared to the relevant comparator.
Summary
IQWiG concluded there was no additional benefit in either proposed indication for ravulizumab over the comparator.