[A25-160] Nipocalimab (generalized myasthenia gravis) – Benefit assessment according to §35a Social Code Book V
Last updated 01.04.2026
Project no.:
A25-160
Commission:
Commission awarded on 01.01.2026 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Head and nerves
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
Note:
After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) 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 G-BA website.
DOI:
https://doi.org/10.60584/A25-160