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) |
| ICD-10 codes (AIS) | G35.10, G35.11, G35.9 |
| Alpha-ID codes (AIS) | I98549Multiple sclerosis with predominantly relapsing-remitting course, I99339Multiple sclerosis |
| DDD | 14 mg O |
| Therapeutic area | Nervous system diseases Multiple sclerosis (MS) / Neuromyelitis optica spectrum disorders (NMOSD) |
| Reason for procedure | New therapeutic indication |
| Specialty | ACT change Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Aubagio is indicated for the treatment of adult patients and children and adolescents aged 10 years and older with relapsing-remitting multiple sclerosis (MS). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| 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 pre-treated with disease-modifying therapy whose disease is not highly active. | Interferon beta-1a or interferon beta-1b or glatiramer acetate, taking into account the approval status |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
| ACT change | 26.05.2020 – Präzisierung der ZVT durch G-BA |
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 |
<< List of all resolutions