Patient group
Erwachsene mit amyotropher Lateralsklerose (ALS), die mit einer Mutation im Superoxid- Dismutase 1 (SOD1)-Gen assoziiert ist
completed2024-07-01D series
Tofersen
Amyotrophe Lateralsklerose (ALS
Open official case page ↗
- Brand
- Qalsody
- Manufacturer
- Biogen GmbH
G-BA action
final resolution
2024-12-19
Arzneimittel-Richtlinie/Anlage XII: Tofersen (Amyotrophe Lateralsklerose (ALS))
Evidence-checked summary
The G-BA found a hint of non-quantifiable added benefit for Erwachsene mit amyotropher Lateralsklerose (ALS), die mit einer Mutation im Superoxid- Dismutase 1 (SOD1)-Gen assoziiert ist. The G-BA issued a final resolution on 2024-12-19. The official page states that it took effect as follows: 19.12.2024. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.
This is the latest validated public action attached to this case. It is separate from the IQWiG assessment result.
Final benefit result
G-BA result by patient group
Official case record
What happened, in source order
No inferred stages
Consultation record
Oral hearing and Wortprotokoll
2024-11-11
126 parsed turns
Oral hearing: Tofersen (Amyotrophe Lateralsklerose (ALS))
Official Wortprotokoll · 16 pages
IQWiG comparison
Assessment record versus G-BA action
IQWiG assessment findings and the later G-BA action are separate records. Open both to compare them.
No IQWiG assessment reference is present on the validated official case page. This is an explicit absence, not a broken graph link.
G-BA decisions
Distinct actions and documents
2024-12-19
final resolution
Arzneimittel-Richtlinie/Anlage XII: Tofersen (Amyotrophe Lateralsklerose (ALS))
The G-BA found a hint of non-quantifiable added benefit for Erwachsene mit amyotropher Lateralsklerose (ALS), die mit einer Mutation im Superoxid- Dismutase 1 (SOD1)-Gen assoziiert ist. The G-BA issued a final resolution on 2024-12-19. The official page states that it took effect as follows: 19.12.2024. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.
3 official documents · 4 cited claims
Official sources
Case document package
official case pageOfficial G-BA case pageOpen ↗gba assessment amendmentAmendment zur Nutzenbewertung des G-BAOpen ↗iqwig cost assessmentBewertung der Therapiekosten und Patientenzahlen IQWiGOpen ↗gba assessmentNutzenbewertung G-BAOpen ↗annex xii current versionTofersenOpen ↗hearing transcriptWortprotokollOpen ↗decision textBeschlusstextOpen ↗decision rationaleTragende Gründe zum BeschlussOpen ↗summary documentationZusammenfassende DokumentationOpen ↗
Generic graph relations · 6
HAS ASSOCIATED DECISIONArzneimittel-Richtlinie/Anlage XII: Tofersen (Amyotrophe Lateralsklerose (ALS))HAS HEARINGOral hearing: Tofersen (Amyotrophe Lateralsklerose (ALS))OWNS DOCUMENTAmendment zur Nutzenbewertung des G-BAOWNS DOCUMENTBewertung der Therapiekosten und Patientenzahlen IQWiGOWNS DOCUMENTNutzenbewertung G-BAOWNS DOCUMENTTofersen