Reason for request

Extension of indication

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Clinical Benefit

Substantial

The actual benefit of BERINERT is substantial in th is extension of the indication to the short-term pre-procedure prevention of acute HAE episodes.


Clinical Added Value

no clinical added value

For the short-term pre-procedure prevention of acute HAE episodes, BERINERT does not provide any improvement in actual benefit (IAB V, non-existent) over other treatments already available.