Dossier assessment
Ravulizumab (paroxysmal nocturnal haemoglobinuria) - Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Ravulizumab (paroxysmal nocturnal haemoglobinuria) - Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Ravulizumab (paroxysmal nocturnal haemoglobinuria) - Benefit assessment according to §35a Social Code Book V
Dossier assessment
Paediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal haemoglobinuria
- 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.
Project details
- Project no.
- A21-125
- Commission
- Commission awarded on 30.09.2021 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Children's and adolescents' health
- 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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