AMNOGEvidence Graph
Cases / 2025-12-15-D-1270
completed2025-12-15D series

Iptacopan

Neubewertung Orphan > 30 Mio: Komplement-3-Glomerulopathie

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Brand
Fabhalta
Manufacturer
Novartis Pharma GmbH

G-BA action

final resolution

2026-06-04

Arzneimittel-Richtlinie/Anlage XII: Iptacopan (Neubewertung eines Orphan Drugs nach Überschreitung der 30 Millionen Euro-Grenze (Komplement-3-Glomerulopathie)

Evidence-checked summary

The G-BA found no proven added benefit for Erwachsene mit Komplement-3-Glomerulopathie (C3G). The appropriate comparator was - Mycophenolatmofetil in Kombination mit Kortikosteroiden. The G-BA issued a final resolution on 2026-06-04. The official page states that it took effect as follows: 04.06.2026. 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.

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Final benefit result

G-BA result by patient group

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Patient group

Erwachsene mit Komplement-3-Glomerulopathie (C3G)

Added benefit not proven

Comparator
- Mycophenolatmofetil in Kombination mit Kortikosteroiden

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Official case record

What happened, in source order

No inferred stages

Consultation record

Oral hearing and Wortprotokoll

1 hearing

2026-04-27

61 parsed turns

Oral hearing: Iptacopan (Neubewertung Orphan > 30 Mio: Komplement-3-Glomerulopathie)

Official Wortprotokoll · 14 pages

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IQWiG comparison

Assessment record versus G-BA action

1 reference

IQWiG assessment findings and the later G-BA action are separate records. Open both to compare them.

A25-157

matched

Iptacopan (complement 3 glomerulopathy) – Benefit assessment according to §35a Social Code Book V

Official assessment PDF · 83 pages

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G-BA decisions

Distinct actions and documents

1 decision

2026-06-04

final resolution

Arzneimittel-Richtlinie/Anlage XII: Iptacopan (Neubewertung eines Orphan Drugs nach Überschreitung der 30 Millionen Euro-Grenze (Komplement-3-Glomerulopathie)

The G-BA found no proven added benefit for Erwachsene mit Komplement-3-Glomerulopathie (C3G). The appropriate comparator was - Mycophenolatmofetil in Kombination mit Kortikosteroiden. The G-BA issued a final resolution on 2026-06-04. The official page states that it took effect as follows: 04.06.2026. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.

2 official documents · 4 cited claims

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Official sources

Case document package

6 source
official case pageOfficial G-BA case pageOpen ↗comparator informationInformationen zur zweckmäßigen VergleichstherapieOpen ↗hearing transcriptWortprotokollOpen ↗decision textBeschlusstextOpen ↗decision rationaleTragende Gründe zum BeschlussOpen ↗iqwig assessmentNutzenbewertung IQWiGOpen ↗
Generic graph relations · 4
HAS ASSESSMENTIptacopanHAS ASSOCIATED DECISIONArzneimittel-Richtlinie/Anlage XII: Iptacopan (Neubewertung eines Orphan Drugs nach Überschreitung der 30 Millionen Euro-Grenze (Komplement-3-Glomerulopathie)HAS HEARINGOral hearing: Iptacopan (Neubewertung Orphan > 30 Mio: Komplement-3-Glomerulopathie)OWNS DOCUMENTInformationen zur zweckmäßigen Vergleichstherapie