[A23-93] Risdiplam (spinal muscular atrophy, < 2 months) – Benefit assessment according to §35a Social Code Book V
Last updated 15.12.2023
Project no.:
A23-93
Commission:
Commission awarded on 14.09.2023 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Muscles, bones and joints
Indication:
5q spinal muscular atrophy in patients < 2 months of age
Result of dossier assessment:
- Presymptomatic, with up to 3 copies of the survival motor neuron 2 gene: added benefit not proven
- Symptomatic, with a clinical diagnosis of spinal muscular atrophy type 1: added benefit not proven
- Presymptomatic, with 4 copies of the survival motor neuron 2 gene: 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://dx.doi.org/10.60584/A23-93