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Dossier assessment

Iptacopan (paroxysmal nocturnal haemoglobinuria) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-156
Last updated

Report documents

  1. Extract of dossier assessment

    Iptacopan (paroxysmal nocturnal haemoglobinuria) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 224 kB, DE, not accessible
    Download file : Extract of dossier assessment (PDF document, 224 kB, DE, not accessible)

  2. Dossier assessment

    Iptacopan (paroxysmal nocturnal haemoglobinuria) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 563 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-156
    Download file : Dossier assessment (PDF document, 563 kB, DE, not accessible)

Drug assessment at a glance

  1. Drug assessment at a glance

    Iptacopan (paroxysmal nocturnal haemoglobinuria) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 211 kB, EN, not accessible
    Download file : Drug assessment at a glance (PDF document, 211 kB, EN, not accessible)

Dossier assessment

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

Additional information

Federal Joint Committee (G-BA)

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

Project details

Project no.
A25-156
Commission
Commission awarded on 15.12.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Haematology
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.

DOI

https://doi.org/10.60584/A25-156

Connected Projects

  1. Dossier assessment

    Iptacopan (complement 3 glomerulopathy) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-157
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Iptacopan (complement 3 glomerulopathy) – Assessment according to §35a (para. 1, sentence 11) Social Code Book V

    Project no.
    G25-16
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Iptacopan (paroxysmal nocturnal haemoglobinuria with haemolytic anaemia) – Assessment according to §35a SGB V (1), Sentence 11

    Project no.
    G24-16
    Last updated

    Status: Commission completed

  4. Addendum

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

    Project no.
    A26-43
    Last updated

    Status: Commission completed

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