Patient group
Postmenopausale Frauen mit manifester Osteoporose und deutlich erhöhtem Frakturrisiko:
Indication of minor added benefit
Comparator
Alendronsäure oder Risedronsäure oder Zoledronsäure oder Denosumab oder Teriparatid
completed2020-03-15D series
Romosozumab
Osteoporose, postmenopausale Frauen
Open official case page ↗
- Brand
- Evenity®
- Manufacturer
- UCB Pharma GmbH
G-BA action
final resolution
2020-09-03
Arzneimittel-Richtlinie/Anlage XII: Romosozumab (Osteoporose, postmenopausale Frauen)
Evidence-checked summary
The G-BA found an indication of minor added benefit for Postmenopausale Frauen mit manifester Osteoporose und deutlich erhöhtem Frakturrisiko:. The appropriate comparator was Alendronsäure oder Risedronsäure oder Zoledronsäure oder Denosumab oder Teriparatid. The G-BA issued a final resolution on 2020-09-03. The official page states that it took effect as follows: 03.09.2020. 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
2020-07-27
99 parsed turns
Oral hearing: Romosozumab (Osteoporose, postmenopausale Frauen)
Official Wortprotokoll · 15 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.
A20-24
matched
Romosozumab (osteoporosis) - Benefit assessment according to §35a Social Code Book V
Official assessment PDF · 75 pages
G-BA decisions
Distinct actions and documents
2020-09-03
final resolution
Arzneimittel-Richtlinie/Anlage XII: Romosozumab (Osteoporose, postmenopausale Frauen)
The G-BA found an indication of minor added benefit for Postmenopausale Frauen mit manifester Osteoporose und deutlich erhöhtem Frakturrisiko:. The appropriate comparator was Alendronsäure oder Risedronsäure oder Zoledronsäure oder Denosumab oder Teriparatid. The G-BA issued a final resolution on 2020-09-03. The official page states that it took effect as follows: 03.09.2020. 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 ↗iqwig addendumAddendum des IQWiGOpen ↗comparator informationInformationen zur zweckmäßigen VergleichstherapieOpen ↗annex xii current versionRomosozumabOpen ↗hearing transcriptWortprotokollOpen ↗decision textBeschlusstextOpen ↗decision rationaleTragende Gründe zum BeschlussOpen ↗summary documentationZusammenfassende DokumentationOpen ↗iqwig assessmentNutzenbewertung IQWiGOpen ↗
Generic graph relations · 6
HAS ASSESSMENTromosozumabHAS ASSOCIATED DECISIONArzneimittel-Richtlinie/Anlage XII: Romosozumab (Osteoporose, postmenopausale Frauen)HAS HEARINGOral hearing: Romosozumab (Osteoporose, postmenopausale Frauen)OWNS DOCUMENTAddendum des IQWiGOWNS DOCUMENTInformationen zur zweckmäßigen VergleichstherapieOWNS DOCUMENTRomosozumab