Teriflunomid (2) – Aubagio®
Relapsing-remitting multiple sclerosis (MS), 10 to 17 years
Characteristics
| Start date | 01.08.2021 – Marketing authorisation: 18.06.2021 |
|---|---|
| Resolution | 20.01.2022 |
| INN | Teriflunomid |
| Brand name | Aubagio® |
| Pharm. company | Sanofi-Aventis Deutschland GmbH |
| G-BA Procedure ID | D-700 |
| ATC code | L04AK02 IMMUNOSUPPRESSANTS (L04A) |
| DDD | 14 mg O |
| Therapeutic area | Nervous system diseases |
| Reason for procedure | New therapeutic indication |
| Specialty | ACT change |
Studies and Results
Children and adolescents aged ≥ 10 to < 18 years with relapsing-remitting multiple sclerosis who have not yet received disease-modifying therapy, or children and adolescents who have previously been treated with disease-modifying therapy and whose disease is not highly active
- The additional benefit is not proven.
- For the assessment of the additional benefit of teriflunomide in the treatment of children and adolescents aged 10 years and over with relapsing-remitting multiple sclerosis, the pharmaceutical manufacturer has not provided any data comparing it with the appropriate comparator therapy.
- Overall assessment
- The additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Teriflunomid (2) | Aubagio® | Sanofi-Aventis Deutschland GmbH | Relapsing-remitting multiple sclerosis (MS), 10 to 17 years | 350–1,200 | 100% additional benefit not proven | |
| Teriflunomid (1) | Aubagio® | Sanofi-aventis groupe/Genzyme GmbH | Relapsing-remitting multiple sclerosis (MS) | 85,000–105,000 | 100% additional benefit not proven |
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