Dossier assessment
Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) - Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) - Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) - Benefit assessment according to §35a Social Code Book V
Dossier assessment
Adults with cystic fibrosis (CF) who have an R117H mutation in the CFTR gene
The advantages in the outcome categories of morbidity and health-related quality of life (in women and in positive Pseudomonas aeruginosa infection status) outweigh the disadvantage in one side effect (oropharyngeal pain); overall hint of non-quantifiable added benefit
Project details
- Project no.
- A19-68
- 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
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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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