Dossier assessment

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

Status
Status: Commission completed
Project no.
A24-94
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 771 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-94_en
  2. Dossier assessment

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

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-94

Dossier assessment

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:
  • Patients with high disease activity, characterized by clinical symptoms of haemolysis: added benefit not proven
  • Adult patients who have been treated with a C5 inhibitor for ≥ 6 months and are clinically stable: hint of lesser benefit
  • Paediatric patients 12 years of age or older who have been treated with a C5 inhibitor for ≥ 6 months and are clinically stable: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

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

G-BA documents on this decision

Project details

Project no.
A24-94
Commission
Commission awarded on 13.09.2024 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/A24-94_en

Connected Projects

  1. Addendum

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

    Project no.
    A25-12
    Last updated

    Status: Commission completed

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