[A21-118] Risdiplam (spinal muscular atrophy) - Addendum to Commission A21-50
Last updated 21.10.2021
Project no.:
A21-118
Commission:
Commission awarded on 07.09.2021 by the Federal Joint Committee (G-BA).
Report type:
Addendum
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Head and nerves
Indication:
Patients with 5q spinal muscular atrophy (SMA), 2 months of age and older
Result of dossier assessment:
Unchanged after addendum:
- SMA type 1: hint of non-quantifiable added benefit.
- SMA type 2: added benefit not proven.
- SMA type 3: added benefit not proven.
- Pre-symptomatic patients with 1 to 3 copies of the SMN2 gene: added benefit not proven.
- Pre-symptomatic patients with 4 copies of the SMN2 gene: added benefit not proven.
Note:
If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.
| Project no. | Title | Status |
|---|---|---|
| A21-50 | Risdiplam (spinal muscular atrophy) - Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2021-10-21: A G-BA decision was published.