Patient group
Erwachsene mit Neuromyelitis-optica-Spektrum-Erkrankungen (NMOSD), die anti-Aquaporin- 4-IgG-(AQP4-IgG-)seropositiv sind
Added benefit not proven
Comparator
Eculizumab (ab dem 2. Schub) oder Satralizumab
completed2023-06-15D series
Ravulizumab
Neuromyelitis-optica-Spektrum-Erkrankungen, Anti-Aquaporin-4-IgG-seropositiv
Open official case page ↗
- Brand
- Ultomiris
- Manufacturer
- Alexion Pharma Germany GmbH
G-BA action
final resolution
2023-12-07
Arzneimittel-Richtlinie/Anlage XII: Ravulizumab (Neues Anwendungsgebiet: Neuromyelitis-optica-Spektrum-Erkrankungen, Anti-Aquaporin-4-IgG-seropositiv)
Evidence-checked summary
The G-BA found no proven added benefit for Erwachsene mit Neuromyelitis-optica-Spektrum-Erkrankungen (NMOSD), die anti-Aquaporin- 4-IgG-(AQP4-IgG-)seropositiv sind. The appropriate comparator was Eculizumab (ab dem 2. Schub) oder Satralizumab. The G-BA issued a final resolution on 2023-12-07. The official page states that it took effect as follows: 07.12.2023. 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
2023-10-23
68 parsed turns
Oral hearing: Ravulizumab (Neuromyelitis-optica-Spektrum-Erkrankungen, Anti-Aquaporin-4-IgG-seropositiv)
Official Wortprotokoll · 13 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.
A23-50
matched
Ravulizumab (neuromyelitis optica spectrum disorder [NMOSD]) – Benefit assessment according to §35a Social Code Book V
Official assessment PDF · 71 pages
G-BA decisions
Distinct actions and documents
2023-12-07
final resolution
Arzneimittel-Richtlinie/Anlage XII: Ravulizumab (Neues Anwendungsgebiet: Neuromyelitis-optica-Spektrum-Erkrankungen, Anti-Aquaporin-4-IgG-seropositiv)
The G-BA found no proven added benefit for Erwachsene mit Neuromyelitis-optica-Spektrum-Erkrankungen (NMOSD), die anti-Aquaporin- 4-IgG-(AQP4-IgG-)seropositiv sind. The appropriate comparator was Eculizumab (ab dem 2. Schub) oder Satralizumab. The G-BA issued a final resolution on 2023-12-07. The official page states that it took effect as follows: 07.12.2023. 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 ↗comparator informationInformationen zur zweckmäßigen VergleichstherapieOpen ↗annex xii current versionRavulizumabOpen ↗hearing transcriptWortprotokollOpen ↗decision textBeschlusstextOpen ↗decision rationaleTragende Gründe zum BeschlussOpen ↗summary documentationZusammenfassende DokumentationOpen ↗iqwig assessmentNutzenbewertung IQWiGOpen ↗
Generic graph relations · 5
HAS ASSESSMENTRavulizumabHAS ASSOCIATED DECISIONArzneimittel-Richtlinie/Anlage XII: Ravulizumab (Neues Anwendungsgebiet: Neuromyelitis-optica-Spektrum-Erkrankungen, Anti-Aquaporin-4-IgG-seropositiv)HAS HEARINGOral hearing: Ravulizumab (Neuromyelitis-optica-Spektrum-Erkrankungen, Anti-Aquaporin-4-IgG-seropositiv)OWNS DOCUMENTInformationen zur zweckmäßigen VergleichstherapieOWNS DOCUMENTRavulizumab