[A24-94] Crovalimab (paroxysmal nocturnal haemoglobinuria) – Benefit assessment according to §35a Social Code Book V
Last updated 16.12.2024
Project no.:
A24-94
Commission:
Commission awarded on 13.09.2024 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Haematology
Indication:
Adult and paediatric patients 12 years of age or older with a weight of ≥ 40 kg with paroxysmal nocturnal haemoglobinuria
Result of dossier assessment:
- Patients with high disease activity, characterized by clinical symptoms of haemolysis: added benefit not proven
- Adult patients who have been treated with a C5 inhibitor for ≥ 6 months and are clinically stable: hint of lesser benefit
- Paediatric patients 12 years of age or older who have been treated with a C5 inhibitor for ≥ 6 months and are clinically stable: 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.
DOI:
https://doi.org/10.60584/A24-94