Patient group
Patienten ab 12 Jahren mit einer akuten hepatischen Porphyrie (AHP)
completed2020-04-15D series
Givosiran
Akute hepatische Porphyrie, ≥ 12 Jahre
Open official case page ↗
- Brand
- Givlaari®
- Manufacturer
- Alnylam Germany GmbH
G-BA action
final resolution
2020-10-15
Arzneimittel-Richtlinie/Anlage XII: Givosiran (Akute hepatische Porphyrie, ≥ 12 Jahre)
Evidence-checked summary
The G-BA found an indication of considerable added benefit for Patienten ab 12 Jahren mit einer akuten hepatischen Porphyrie (AHP). The G-BA issued a final resolution on 2020-10-15. The official page states that it took effect as follows: 15.10.2020. 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
2020-08-24
110 parsed turns
Oral hearing: Givosiran (Akute hepatische Porphyrie, ≥ 12 Jahre)
Official Wortprotokoll · 19 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
2020-10-15
final resolution
Arzneimittel-Richtlinie/Anlage XII: Givosiran (Akute hepatische Porphyrie, ≥ 12 Jahre)
The G-BA found an indication of considerable added benefit for Patienten ab 12 Jahren mit einer akuten hepatischen Porphyrie (AHP). The G-BA issued a final resolution on 2020-10-15. The official page states that it took effect as follows: 15.10.2020. 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 ↗gba assessment amendmentAmendment zur Nutzenbewertung des G-BAOpen ↗iqwig cost assessmentBewertung der Therapiekosten und Patientenzahlen IQWiGOpen ↗annex xii current versionGivosiranOpen ↗gba assessmentNutzenbewertung G-BAOpen ↗hearing transcriptWortprotokollOpen ↗decision textBeschlusstextOpen ↗decision rationaleTragende Gründe zum BeschlussOpen ↗summary documentationZusammenfassende DokumentationOpen ↗
Generic graph relations · 6
HAS ASSOCIATED DECISIONArzneimittel-Richtlinie/Anlage XII: Givosiran (Akute hepatische Porphyrie, ≥ 12 Jahre)HAS HEARINGOral hearing: Givosiran (Akute hepatische Porphyrie, ≥ 12 Jahre)OWNS DOCUMENTAmendment zur Nutzenbewertung des G-BAOWNS DOCUMENTBewertung der Therapiekosten und Patientenzahlen IQWiGOWNS DOCUMENTGivosiranOWNS DOCUMENTNutzenbewertung G-BA