[A21-50] Risdiplam (spinal muscular atrophy) - Benefit assessment according to §35a Social Code Book V
Last updated 21.10.2021
Project no.:
A21-50
Commission:
Commission awarded on 30.04.2021 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Head and nerves
Indication:
Patients with 5q spinal muscular atrophy (SMA)
Result of dossier assessment:
- Patients 2 months of age and older with SMA type 1: hint of a non-quantifiable added benefit.
- Patients 2 months of age and older with SMA type 2 or 3, and pre-symptomatic patients with up to 4 SMN2 gene copies: 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.
| Project no. | Title | Status |
|---|---|---|
| A21-118 | Risdiplam (spinal muscular atrophy) - Addendum to Commission A21-50 | Commission completed |
Federal Joint Committee (G-BA)
2021-10-21: A G-BA decision was published.