Dossier assessment

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

Status
Status: Commission completed
Project no.
A25-157
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 267 kB, DE, not accessible
  2. Dossier assessment

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

    published on
    Document type
    PDF document, 857 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-157

Drug assessment at a glance

  1. Drug assessment at a glance

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

    published on
    Document type
    PDF document, 231 kB, EN, not accessible

Dossier assessment

Indication:

Adults with complement 3 glomerulopathy

Result of dossier assessment:
  • Iptacopan as add-on therapy to mycophenolate mofetil and corticosteroids: added benefit not proven (based on the results of the relevant study)
  • Iptacopan monotherapy: added benefit not proven (no relevant study)

Project details

Project no.
A25-157
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
Kidneys and urinary system
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/A25-157

Connected Projects

  1. 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

  2. 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

  3. Dossier assessment

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

    Project no.
    A25-156
    Last updated

    Status: Commission completed

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