[G15-14] Lumacaftor/ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V
Last updated 02.06.2016
Project no.:
G15-14
Commission:
Commission awarded on 14.12.2015 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Health Economics
Topic:
Airways and respiratory system
In accordance with § 35a (para. 1, sentence 10) Social Code Book V, the added medical benefit of orphan drugs is deemed as proven by the fact that they have been approved. For the Lumacaftor/ivacaftor report commissioned by the Federal Joint Committee (G-BA), IQWiG therefore solely assesses the information on patient numbers and costs in the pharmaceutical company's dossier. After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. The resolution on the extent of added benefit is passed by the G-BA after the hearing. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA Website.
| Project no. | Title | Status |
|---|---|---|
| A19-13 | Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A18-08 | Lumacaftor/ivacaftor (cystic fibrosis) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A21-122 | Lumacaftor/ivacaftor (cystic fibrosis, homozygous F508del mutation in the CFTR gene, 2-5 years) - Benefit assessment according to §35a Social Code Book V (expiry of the limitation period) | Commission completed |
| A23-72 | Lumacaftor/ivacaftor (cystic fibrosis, 1 to < 2 years, F508del mutation, homozygous) – Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2016-06-02 A G-BA decision was published.