[A25-156] Iptacopan (paroxysmal nocturnal haemoglobinuria) – Benefit assessment according to §35a Social Code Book V

Last updated 16.03.2026

Project no.:
A25-156

Commission:
Commission awarded on 15.12.2025 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Haematology

Indication:

Adults with paroxysmal nocturnal haemoglobinuria (PNH)

Result of dossier assessment:
  • Patients with haemolytic anaemia who are treatment-naive: added benefit not proven
  • Patients who still have haemolytic anaemia and have received prior treatment: 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/A25-156

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