Addendum
Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor, cystic fibrosis, 12 years and older, F508del mutation, homozygous) - Addendum to Commission A20-77
Report documents
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Addendum
Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor, cystic fibrosis, 12 years and older, F508del mutation, homozygous) - Addendum to Commission A20-77
Dossier assessment
Indication:
Patients with cystic fibrosis aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene
Result of dossier assessment:
Now indication of major added benefit
Press releases
Clinical relevance of patient-reported outcomes: new threshold proven feasible in practice
Current examples prove the feasibility of the 15 percent threshold newly defined by IQWiG for the acceptance of responder analyses in early benefit assessments of drugs.
Additional information
Federal Joint Committee (G-BA)
2021.02.18 A G-BA decision was published.
Project details
- Project no.
- A21-03
- Commission
- Commission awarded on 12.01.2021 by the Federal Joint Committee (GBA).
- Report type
- Addendum
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Airways and respiratory system
- 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.
Connected Projects
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Dossier assessment
Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor, cystic fibrosis, 12 years and older, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed