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New HTA Decisions in Germany
December 2020
Drug name
SYMKEVI® (ivacaftor + tezacaftor / ivacaftor)
Company
Vertex Pharmaceuticals
Decision date
01/10/2020
Therapeutic area
Respiratory conditions
Therapeutic sub area
Cystic fibrosis
G-BA decision date
15/12/2020
Orphan Drug?
Yes
Decision
No additional benefit
Indication
Patients from 12 years of age with cystic fibrosis with heterozygous F508del mutation in the CFTR gene. Main comparators: BSC
Decision Detail
Main studies: VX14-661-108 and VX14-661-106 Main driver of decision: Study VX14-661-106 included patients homozygous for the F508del mutation so this study was not included. As the VX14-661-108 study was 8 weeks in duration, IQWiG concluded that it was too short to be included in this benefit assessment. Due to the rarity of mutations and the extent to which children are affected, IQWiG considered the short-term results of this study, and concluded that tezacaftor/ivacaftor improved quality of life and that there was no difference in adverse events between this drug and the comparator.
Summary
Although IQWiG concluded that there was no additional benefit proven, the G-BA concluded that tezacaftor/ivacaftor has a minor additional benefit, because of this drug's orphan designation.