Tafamidis (3) – Vyndaqel®
Amyloid Neuropathy
Characteristics
| Start date | 01.12.2020 – Marketing authorisation: 16.11.2011 |
|---|---|
| Resolution | 20.05.2021 |
| INN | Tafamidis |
| Brand name | Vyndaqel® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-611 |
| ATC code | N07XX08 Other nervous system drugs (N07XX) |
| DDD | 20 mg O |
| Therapeutic area | Metabolic diseases Orphan (turnover limit) |
| Reason for procedure |
Reassessment: Orphan turnover exceeded
Original resolution: Tafamidis (1) (07.06.2012) |
| Regulatory status | Exceptional Circumstances |
| Specialty | Bundling |
Studies and Results
- Clinical trials
- In its dossier for the assessment of the additional benefit of Tafamidis, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
- Furthermore, no indirect comparisons were presented to address the issues raised in the benefit assessment.
Adult patients with transthyretin amyloidosis and symptomatic stage 1 polyneuropathy
- For adult patients with transthyretin amyloidosis and symptomatic stage 1 polyneuropathy, the additional benefit of Tafamidis compared with the appropriate comparator therapy is not proven.
- In its dossier for the assessment of the additional benefit of tafamidis, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
- Furthermore, no indirect comparisons were submitted to address the issues raised in the benefit assessment.
- Consequently, there are no suitable data available overall for the assessment of the additional benefit of Tafamidis.
- Overall assessment
- On balance, for adult patients with transthyretin amyloidosis and symptomatic stage 1 polyneuropathy, the additional benefit of Tafamidis compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Tafamidis (4) | Vyndaqel® | Pfizer Pharma GmbH | Amyloid cardiomyopathy | 1,760–1,810 | 100% Indication of considerable additional benefit Orphan (turnover limit) | |
| Tafamidis (3) | Vyndaqel® | Pfizer Pharma GmbH | Amyloid Neuropathy | 230 | 100% additional benefit not proven Orphan (turnover limit) | |
| Tafamidis (2) | Vyndaqel® | Pfizer Pharma GmbH | Amyloid cardiomyopathy |
0
1,630–1,730 |
100% Hint for considerable additional benefit Orphan repealed | |
| Tafamidis (1) | Vyndaqel® | Pfizer Pharma GmbH | Amyloid Neuropathy |
0
40–104 |
100% minor additional benefit Orphan repealed |
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