Dossier assessment
Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V
Report documents
-
Extract of dossier assessment
Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V
-
Dossier assessment
Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V
Dossier assessment
Cystic fibrosis in children aged 2 years and older and weighing 7 to < 25 kg who have a G551D, G551S, G1244E, G1349D, G178R, S1251N, S1255P, S549N or S549R mutation in the CFTR gene
Transfer of the results from studies with older patients not possible; added benefit not proven
Project details
- Project no.
- A19-67
- Commission
- Commission awarded on 28.08.2019 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Airways and respiratory system
- Note
-
After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.
Connected Projects
-
Dossier assessment
Ivacaftor (cystic fibrosis, 6 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (cystic fibrosis) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (cystic fibrosis, from 12 to < 24 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor - Assessment according to § 35a (1), Sentence 10, Social Code Book V (dossier assessment)
Status: Commission completed
-
Dossier assessment
Ivacaftor (combination with tezacaftor/ivacaftor; cystic fibrosis, 6 to < 12 years, F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (cystic fibrosis, 4 to < 6 months, gating mutation) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (combination with tezacaftor/ivacaftor; cystic fibrosis, 6 to < 12 years, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (cystic fibrosis, 4 to < 6 months, with R117H mutation) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (cystic fibrosis, 6 months to < 18 years, with R117H mutation)- Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor, cystic fibrosis, 12 years and older, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 12 years and older, F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed
-
Dossier assessment
Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed