Dossier assessment
Ivacaftor (cystic fibrosis, 4 to < 6 months, gating mutation) - Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Ivacaftor (cystic fibrosis, 4 to < 6 months, gating mutation) - Benefit assessment according to §35a
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Dossier assessment
Ivacaftor (cystic fibrosis, 4 to < 6 months, gating mutation) - Benefit assessment according to §35a
Dossier assessment
Patients with cystic fibrosis from 4 to < 6 months of age and weighing 5 kg or more who have one of the following gating (class III) mutations in the CFTR gene: G551D, G551S, G1244E, G1349D, G178R, S1251N, S1255P, S549N or S549R
Added benefit not proven.
Project details
- Project no.
- A20-100
- Commission
- Commission awarded on 27.11.2020 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Airways and respiratory system
- Note
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After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.
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