Dossier assessment
Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V
Dossier assessment
Infants with cystic fibrosis, aged 6 to < 12 months, weighing 5 kg or more, with one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R
Transfer of the results from studies with older patients not possible; added benefit not proven
Project details
- Project no.
- A19-105
- Commission
- Commission awarded on 16.12.2019 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Children's and adolescents' health
- Note
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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.
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