Addendum
Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 2 to 5 years, F508del mutation, homozygous) – Addendum to Project A23-123
Report documents
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Addendum
Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 2 to 5 years, F508del mutation, homozygous) – Addendum to Project A23-123
Dossier assessment
Indication:
Patients with cystic fibrosis from 2 to 5 years of age who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene
Result of dossier assessment:
Unchanged after addendum:
added benefit not proven
Additional information
Federal Joint Committee (G-BA)
2024-05-16 A G-BA decision was published.
Project details
- Project no.
- A24-44
- Commission
- Commission awarded on 15.04.2024 by the Federal Joint Committee (GBA).
- Report type
- Addendum
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Digestion, metabolism and hormones
- Note
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If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.
- DOI
https://doi.org/10.60584/A24-44_en
Connected Projects
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Dossier assessment
Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, homozygous) – Benefit assessment according to §35a Social Code Book
Status: Commission completed