Patient group
Erwachsene, die eine prozedurale Sedierung benötigen
Added benefit not proven
Comparator
Individualisierte Therapie unter Auswahl von − Propofol − Midazolam − Dexmedetomidin
completed2026-01-01D series
Remimazolam
Prozedurale Sedierung
Open official case page ↗
- Brand
- Byfavo
- Manufacturer
- Paion Pharma GmbH
G-BA action
final resolution
2026-06-18
Arzneimittel-Richtlinie/Anlage XII: Remimazolam (prozedurale Sedierung)
Evidence-checked summary
The G-BA found no proven added benefit for Erwachsene, die eine prozedurale Sedierung benötigen. The appropriate comparator was Individualisierte Therapie unter Auswahl von − Propofol − Midazolam − Dexmedetomidin. The G-BA issued a final resolution on 2026-06-18. The official page states that it took effect as follows: 18.06.2026. 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
2026-05-11
33 parsed turns
Oral hearing: Remimazolam (Prozedurale Sedierung)
Official Wortprotokoll · 9 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.
A25-161
matched
Remimazolam (procedural sedation) – Benefit assessment according to §35a Social Code Book V
Official assessment PDF · 66 pages
G-BA decisions
Distinct actions and documents
2026-06-18
final resolution
Arzneimittel-Richtlinie/Anlage XII: Remimazolam (prozedurale Sedierung)
The G-BA found no proven added benefit for Erwachsene, die eine prozedurale Sedierung benötigen. The appropriate comparator was Individualisierte Therapie unter Auswahl von − Propofol − Midazolam − Dexmedetomidin. The G-BA issued a final resolution on 2026-06-18. The official page states that it took effect as follows: 18.06.2026. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.
2 official documents · 4 cited claims
Official sources