Acoramidis (1) – Beyonttra®
Hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
Characteristics
| Start date | 01.04.2025 – Marketing authorisation: 10.02.2025 |
|---|---|
| Resolution | 18.09.2025 |
| INN | Acoramidis |
| Brand name | Beyonttra® |
| Pharm. company | Bayer Vital GmbH |
| G-BA Procedure ID | D-1167 |
| ATC code | C01EB25 Other cardiac preparations (C01EB) |
| Therapeutic area | Metabolic diseases |
| Reason for procedure | Initial assessment |
Studies and Results
Adults with wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM)
- The additional benefit is not proven.
- No direct comparative study is available to assess the additional benefit of Acoramidis in comparison with the appropriate comparator therapy, Tafamidis.
- Overall, there are no suitable data available for assessing the additional benefit of Acoramidis compared with the appropriate comparator therapy, Tafamidis.
- In summary, it is concluded that, for adults with wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM), the additional benefit of Acoramidis over the appropriate comparator therapy, Tafamidis, is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Acoramidis (1) | Beyonttra® | Bayer Vital GmbH | Hereditary transthyretin amyloidosis in adult patients with cardiomyopathy | 1,760–2,120 | 100% additional benefit not proven |
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