Reason for request
Extension of indication
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. |
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