Addendum

Nusinersen (spinal muscular atrophy) - Addendum to Commission A20-114

Status
Status: Commission completed
Project no.
A21-43
Last updated

Report documents

  1. Addendum

    Nusinersen (spinal muscular atrophy) - Addendum to Commission A20-114

    published on
    Document type
    PDF-Dokument, 549 kB, EN, PDF

Dossier assessment

Indication:

Patients with 5q spinal muscular atrophy (SMA)

Result of dossier assessment:

Patients with early onset of disease (infantile form, SMA type 1): indication of major added benefit.

Patients with later onset of disease (SMA type 2, type 3 and type 4): added benefit not proven.

Pre-symptomatic patients with 5q SMA: hint of non-quantifiable added benefit.

Additional information

Federal Joint Committee (G-BA)

2021.05.20 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A21-43
Commission
Commission awarded on 07.04.2021 by the Federal Joint Committee (GBA).
Report type
Addendum
Status
Commission completed
Department/Division
Drug Assessment
Topic
Muscles, bones and joints
Note

If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.

Connected Projects

  1. Dossier assessment

    Nusinersen (spinal muscular atrophy) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-114
    Last updated

    Status: Commission completed

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