Considering the seriousness of the condition, the good benefit-risk profile of KAFTRIO®/KALYDECO®, the alternatives available, the important place of KAFTRIO®/KALYDECO® in the therapeutic strategy, and the likely impact of KAFTRIO®/KALYDECO® on public health, the committee considered the actual benefit of KAFTRIO®/KALYDECO® to be ‘important’ in the indication of the Marketing Authorisation and proposed a reimbursement rate of 65%. Furthermore, given the benefit of KAFTRIO®/KALYDECO® in terms of FEV1 and sweat chloride level, its favourable safety profile, the partially covered medical need, and the lack of impact of triple therapy on quality of life, the committee considered that KAFTRIO®/KALYDECO® provides a minor improvement in actual benefit (ASMR IV) in this indication. It was concluded that the target population for KAFTRIO®/KALYDECO® is estimated to be 530 patients.