Patient group
Erwachsene mit Visusbeeinträchtigung infolge eines diabetischen Makulaödems (DMÖ)
completed2022-05-01D series
Brolucizumab
Neues Anwendungsgebiet: diabetisches Makulaödem
Open official case page ↗
- Brand
- Beovu
- Manufacturer
- Novartis Pharma GmbH
G-BA action
final resolution
2022-10-20
Arzneimittel-Richtlinie/Anlage XII: Brolucizumab (Neues Anwendungsgebiet: diabetisches Makulaödem)
Evidence-checked summary
The G-BA found no proven added benefit for Erwachsene mit Visusbeeinträchtigung infolge eines diabetischen Makulaödems (DMÖ). The appropriate comparator was Ranibizumab oder Aflibercept. The G-BA issued a final resolution on 2022-10-20. The official page states that it took effect as follows: 20.10.2022. 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
2022-09-05
82 parsed turns
Oral hearing: Brolucizumab (Neues Anwendungsgebiet: diabetisches Makulaödem)
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.
A22-50
matched
Brolucizumab (visual impairment due to diabetic macular oedema) – Benefit assessment according to §35a Social Code Book V
Official assessment PDF · 64 pages
G-BA decisions
Distinct actions and documents
2022-10-20
final resolution
Arzneimittel-Richtlinie/Anlage XII: Brolucizumab (Neues Anwendungsgebiet: diabetisches Makulaödem)
The G-BA found no proven added benefit for Erwachsene mit Visusbeeinträchtigung infolge eines diabetischen Makulaödems (DMÖ). The appropriate comparator was Ranibizumab oder Aflibercept. The G-BA issued a final resolution on 2022-10-20. The official page states that it took effect as follows: 20.10.2022. 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 ↗annex xii current versionBrolucizumabOpen ↗comparator informationInformationen zur zweckmäßigen VergleichstherapieOpen ↗hearing transcriptWortprotokollOpen ↗decision textBeschlusstextOpen ↗decision rationaleTragende Gründe zum BeschlussOpen ↗summary documentationZusammenfassende DokumentationOpen ↗iqwig assessmentNutzenbewertung IQWiGOpen ↗
Generic graph relations · 5
HAS ASSESSMENTbrolucizumabHAS ASSOCIATED DECISIONArzneimittel-Richtlinie/Anlage XII: Brolucizumab (Neues Anwendungsgebiet: diabetisches Makulaödem)HAS HEARINGOral hearing: Brolucizumab (Neues Anwendungsgebiet: diabetisches Makulaödem)OWNS DOCUMENTBrolucizumabOWNS DOCUMENTInformationen zur zweckmäßigen Vergleichstherapie