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Dossier assessment

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

Status
Status: Commission completed
Project no.
A25-160
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 281 kB, DE, not accessible
    Download file : Extract of dossier assessment (PDF document, 281 kB, DE, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 859 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-160
    Download file : Dossier assessment (PDF document, 859 kB, DE, not accessible)

Drug assessment at a glance

  1. Drug assessment at a glance

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

    published on
    Document type
    PDF document, 230 kB, EN, not accessible
    Download file : Drug assessment at a glance (PDF document, 230 kB, EN, not accessible)

Dossier assessment

Indication:

Adult and adolescent patients aged 12 years of age and older with generalized myasthenia gravis

Result of dossier assessment:
  • Adults with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis for whom add-on therapy to standard treatment is an option: added benefit not proven
  • Adults with anti-muscle-specific tyrosine kinase (MuSK) antibody-positive generalized myasthenia gravis for whom add-on therapy to standard treatment is an option: added benefit not proven
  • Adolescents (12 to 17 years) with anti-AChR antibody-positive refractory generalized myasthenia gravis for whom add-on therapy to standard treatment is an option: added benefit not proven
  • Adolescents (12 to 17 years) with anti-AChR antibody-positive nonrefractory generalized myasthenia gravis or with anti-MuSK antibody-positive generalized myasthenia gravis for whom add-on therapy to standard treatment is an option: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

18-06-2026 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A25-160
Commission
Commission awarded on 01.01.2026 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/A25-160

Connected Projects

  1. Addendum

    Nipocalimab (generalized myasthenia gravis) – Addendum to Project A25-160

    Project no.
    A26-51
    Last updated

    Status: Commission completed

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