Addendum

Iptacopan (paroxysmal nocturnal haemoglobinuria) – Addendum to Project A25-156

Report documents

Indication:

Adults with paroxysmal nocturnal haemoglobinuria (PNH)

Result of dossier assessment:

Patients with haemolytic anaemia who are treatment-naive: unchanged after addendum: added benefit not proven
Patients who still have haemolytic anaemia and have received prior treatment: unchanged after addendum: added benefit not proven

05-06-2026 A G-BA decision was published.
G-BA documents on this decision

Project no.: A26-43
Commission: Commission awarded on 28.04.2026 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/A26-43

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