Considering the potential severity of the condition, the good benefit-risk profile of ORLADEYO®, the alternatives available, the place of ORLADEYO® in the therapeutic strategy, and the unlikely impact of ORLADEYO® on public health, the committee considered the actual benefit of ORLADEYO® to be ‘moderate’ in the indication of the Marketing Authorisation, but only as a 2nd line treatment- proposing a reimbursement rate of 35%. Furthermore, given the demonstrated clinical efficacy of ORLADEYO® versus placebo, the tolerance profile, the medical need already covered by the existence of alternatives, and the absence of comparative data on drugs used as 2nd line treatment, the committee considered that ORLADEYO® provides no improvement in actual benefit (ASMR V) in this indication. It was concluded that the target population for ORLADEYO® is estimated to be between 150 and 300 people.