Log in or register to see all Alerts
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
Minor additional benefit
Indication
Patients aged 12 years and above with cystic fibrosis with homozygous F508del mutation of the CFTR gene. Main comparators: lumacaftor/ivacaftor
Decision Detail
Main study: VX14-661-106 Main driver of decision: No significant difference between ivacaftor + tezacaftor / ivacaftor and the comparator was observed in multiple areas including measures of morbidity and mortality, with ivacaftor + tezacaftor / ivacaftor demonstrating improved side effects.
Summary
Although IQWiG concluded that there was minor additional benefit of ivacaftor + tezacaftor / ivacaftor, the G-BA concluded that there was considerable additional benefit due to this drug's orphan designation.