Dossier assessment

Inebilizumab (generalized myasthenia gravis) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A26-27
Last updated

Report documents

  1. Extract of dossier assessment

    Inebilizumab (generalized myasthenia gravis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 132 kB, DE, PDF
  2. Dossier assessment

    Inebilizumab (generalized myasthenia gravis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 586 kB, DE, PDF
    DOI-Link
    https://doi.org/10.60584/A26-27

Drug assessment at a glance

  1. Drug assessment at a glance

    Inebilizumab (generalized myasthenia gravis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 210 kB, EN, PDF

Dossier assessment

Indication:

Adults with generalized myasthenia gravis for whom add-on therapy to standard treatment is an option

Result of dossier assessment:
  • Patients with anti-AChR antibody-positive generalized myasthenia gravis: added benefit not proven
  • Patients with anti-MuSK antibody-positive generalized myasthenia gravis: added benefit not proven

Project details

Project no.
A26-27
Commission
Commission awarded on 12.03.2026 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Head and nerves
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/A26-27

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