[A25-149] Vutrisiran (transthyretin amyloidosis with cardiomyopathy) – Addendum to Project A25-93
Last updated 22.01.2026
Project no.:
A25-149
Commission:
Commission awarded on 28.11.2025 by the Federal Joint Committee (G-BA).
Report type:
Addendum
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Heart and circulation
Indication:
Wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)
Result of dossier assessment:
- Vutrisiran as an add-on to existing tafamidis therapy: unchanged after addendum: added benefit not proven (data from the HELIOS-B study were not presented)
- Vutrisiran monotherapy: unchanged after addendum: added benefit not proven (no relevant study)
Note:
If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.
DOI:
https://doi.org/10.60584/A25-149
| Project no. | Title | Status |
|---|---|---|
| A25-93 | Vutrisiran (transthyretin amyloidosis with cardiomyopathy) – Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
22-01-2026 A G-BA decision was published.