[A21-125] Ravulizumab (paroxysmal nocturnal haemoglobinuria) - Benefit assessment according to §35a Social Code Book V
Last updated 03.01.2022
Project no.:
A21-125
Commission:
Commission awarded on 30.09.2021 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Children's and adolescents' health
Indication:
Paediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal haemoglobinuria
Result of dossier assessment:
- With haemolysis with clinical symptom(s) indicative of high disease activity: added benefit not proven.
- Patients who are clinically stable after having been treated with eculizumab for at least the past 6 months: added benefit not proven.
Note:
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.
| Project no. | Title | Status |
|---|---|---|
| A20-68 | Ravulizumab (atypical haemolytic uraemic syndrome) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A22-115 | Ravulizumab (generalized myasthenia gravis) – Benefit assessment according to § 35a SGB V | Commission completed |
| A23-50 | Ravulizumab (neuromyelitis optica spectrum disorder [NMOSD]) – Benefit assessment according to §35a Social Code Book V | Commission completed |