[A25-12] Crovalimab (paroxysmal nocturnal haemoglobinuria) – Addendum to Project A24-94
Last updated 06.03.2025
Project no.:
A25-12
Commission:
Commission awarded on 28.01.2025 by the Federal Joint Committee (G-BA).
Report type:
Addendum
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:
After addendum now:
- Patients with high disease activity, characterized by clinical symptoms of haemolysis: added benefit not proven
- Patients who have been treated with a C5 inhibitor for ≥ 6 months and are clinically stable: added benefit not proven
Note:
If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.
DOI:
https://doi.org/10.60584/A25-12_en
| Project no. | Title | Status |
|---|---|---|
| A24-94 | Crovalimab (paroxysmal nocturnal haemoglobinuria) – Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2025-03-06 A G-BA decision was published.