Dossier assessment
Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V
Dossier assessment
Patients with cystic fibrosis from 6 to 11 years of age who are heterozygous for the F508del mutation in the CFTR gene and have a gating mutation (including R117H) on the second allele
Added benefit not proven
Project details
- Project no.
- A22-17
- Commission
- Commission awarded on 09.02.2022 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Digestion, metabolism and hormones
- 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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