Cases / 2025-07-15-D-1214
completed2025-07-15D series

Vutrisiran

Neues Anwendungsgebiet: Wildtyp- oder hereditäre Transthyretin-Amyloidose mit Kardiomyopathie

Open official case page ↗
Brand
Amvuttra
Manufacturer
Alnylam Germany GmbH

G-BA action

final resolution

2026-01-22

Arzneimittel-​​​Richtlinie/Anlage XII: Vutrisiran (Neues Anwendungsgebiet: Wildtyp- oder hereditäre Transthyretin-Amyloidose mit Kardiomyopathie)

Evidence-checked summary

The G-BA found no proven added benefit for Erwachsene mit Wildtyp- oder hereditärer Transthyretin-Amyloidose mit Kardiomyopathie (ATTR-CM). The appropriate comparator was - Tafamidis. The G-BA issued a final resolution on 2026-01-22. The official page states that it took effect as follows: 22.01.2026. 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

Open decision 7648 →

Patient group

Erwachsene mit Wildtyp- oder hereditärer Transthyretin-Amyloidose mit Kardiomyopathie (ATTR-CM)

Added benefit not proven

Comparator
- Tafamidis

Open official result PDF ↗

Official case record

What happened, in source order

No inferred stages

Consultation record

Oral hearing and Wortprotokoll

1 hearing

2025-11-24

77 parsed turns

Oral hearing: Vutrisiran (Neues Anwendungsgebiet: Wildtyp- oder hereditäre Transthyretin-Amyloidose mit Kardiomyopathie)

Official Wortprotokoll · 13 pages

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.

A25-93

matched

Vutrisiran (transthyretin amyloidosis with cardiomyopathy) – Benefit assessment according to §35a Social Code Book V

Official assessment PDF · 50 pages

G-BA decisions

Distinct actions and documents

1 decision

2026-01-22

final resolution

Arzneimittel-​​​Richtlinie/Anlage XII: Vutrisiran (Neues Anwendungsgebiet: Wildtyp- oder hereditäre Transthyretin-Amyloidose mit Kardiomyopathie)

The G-BA found no proven added benefit for Erwachsene mit Wildtyp- oder hereditärer Transthyretin-Amyloidose mit Kardiomyopathie (ATTR-CM). The appropriate comparator was - Tafamidis. The G-BA issued a final resolution on 2026-01-22. The official page states that it took effect as follows: 22.01.2026. 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

8 source
Generic graph relations · 5