Dimethylfumarat (2) – Tecfidera®
Relapsing-remitting multiple sclerosis (MS) (new indication: children and adolescents aged 13 years and older))
Characteristics
| Start date | 15.07.2023 – Marketing authorisation: 13.05.2022 |
|---|---|
| Resolution | 18.01.2024 |
| Limitation date | 01.07.2024 limitation repealed |
| INN | Dimethylfumarat |
| Brand name | Tecfidera® |
| Pharm. company | Biogen GmbH |
| G-BA Procedure ID | D-829 |
| ATC code | L04AX07 Other immunosuppressants (L04AX) |
| ICD-10 codes (AIS) | G35.10, G35.11, G35.9 |
| Alpha-ID codes (AIS) | I98549Multiple sclerosis with predominantly relapsing-remitting course, I99339Multiple sclerosis |
| DDD | 0.48 g 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 |
|---|
|
Tecfidera is used to treat children and adolescents aged 13 and over with relapsing-remitting multiple sclerosis (RRMS). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children and adolescents aged ≥ 13 to < 18 years with relapsing-remitting multiple sclerosis (RRMS) who have not yet received disease-modifying therapy, or children and adolescents who have received disease-modifying therapy and whose disease is not highly active | Interferon-beta 1b or glatiramer acetate or teriflunomide, taking into account the authorisation status |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (CONNECT Teil 1) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 15.02.2022 – Änderung der Zulassung |
- Clinical trials
- The pharmaceutical manufacturer has submitted data from the randomised, open-label CONNECT Part 1 trial for the benefit assessment, in which dimethyl fumarate was compared with the active ingredient interferon-beta 1a (medicinal product: Avonex™) over a period of 96 weeks.
Children and adolescents aged ≥ 13 to < 18 years with relapsing-remitting multiple sclerosis (RRMS) who have not yet received disease-modifying therapy, or children and adolescents previously treated with disease-modifying therapy whose disease is not highly active
- For children and adolescents aged ≥ 13 to < 18 years with relapsing-remitting multiple sclerosis (RRMS) 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.
- The additional benefit of dimethyl fumarate compared with the appropriate comparator therapy is therefore not proven.
- For children and adolescents aged ≥ 13 to < 18 years with relapsing-remitting multiple sclerosis (RRMS) who have not yet received disease-modifying therapy, or children and adolescents who have previously received disease-modifying therapy and whose disease is not highly active, no data are available comparing dimethyl fumarate with the appropriate comparator therapy.
- Overall review
- In summary, there are therefore no suitable data available for comparing dimethyl fumarate with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Dimethylfumarat (2) | Tecfidera® | Biogen GmbH | Relapsing-remitting multiple sclerosis (MS) (new indication: children and adolescents aged 13 years and older)) | 350–1,200 | 100% additional benefit not proven | |
| Dimethylfumarat (1) | Tecfidera® | Biogen Idec GmbH | Relapsing-remitting multiple sclerosis (MS) | 85,000–105,000 | 100% additional benefit not proven |
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