Addendum

Crovalimab (paroxysmal nocturnal haemoglobinuria) – Addendum to Project A24-94

Report documents

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

2025-03-06 A G-BA decision was published.

Project no.: A25-12
Commission: Commission awarded on 28.01.2025 by the Federal Joint Committee (GBA).
Report type: Addendum
Status: Commission completed
Department/Division: Drug Assessment
Topic: Haematology
Note: If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.
DOI: https://doi.org/10.60584/A25-12_en

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