[A26-51] Nipocalimab (generalized myasthenia gravis) – Addendum to Project A25-160
Last updated 18.06.2026
Project no.:
A26-51
Commission:
Commission awarded on 12.05.2026 by the Federal Joint Committee (G-BA).
Report type:
Addendum
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: unchanged after addendum: 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: unchanged after addendum: 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: unchanged after addendum: 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: unchanged after addendum: added benefit not proven
Note:
If the need for additional work on a project commissioned by the G-BA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.
DOI:
https://doi.org/10.60584/A26-51
| Project no. | Title | Status |
|---|---|---|
| A25-160 | Nipocalimab (generalized myasthenia gravis) – Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
18-06-2026 A G-BA decision was published.
G-BA documents on this decision