Secukinumab (6) – Cosentyx®
Axial spondyloarthritis
Characteristics
| Start date | 01.09.2020 – Marketing authorisation: 28.04.2020 |
|---|---|
| Resolution | 18.02.2021 |
| INN | Secukinumab |
| Brand name | Cosentyx® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-578 |
| ATC code | L04AC10 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | M45.00, M45.01, M45.02, M45.03, M45.04, M45.05, M45.06, M45.07, M45.08, M45.09 |
| Alpha-ID codes (AIS) | I117306Non-radiographic axial spondyloarthritis, I80914Spondylitis in chronic polyarthritis |
| DDD | 10 mg P |
| Therapeutic area | Musculoskeletal system diseases Axial spondyloarthritis / Ankylosing spondylitis (Bechterews disease) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). | A TNF-α inhibitor (etanercept or adalimumab or golimumab or certolizumab pegol) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
- Clinical trials
- In its dossier for the assessment of the additional benefit of secukinumab, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
Adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) and/or evidence from magnetic resonance imaging (MRI), who have responded inadequately to non-non-steroidal anti-inflammatory drugs (NSAIDs)
- For adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or evidence from magnetic resonance imaging (MRI), who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), the additional benefit of secukinumab compared with the appropriate comparator therapy is not proven.
- In its dossier for the assessment of the additional benefit of secukinumab, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
- Furthermore, no indirect comparisons were presented to address the benefit assessment question.
- In the absence of direct comparative data, the pharmaceutical manufacturer examined the possibility of an adjusted indirect comparison via a bridge comparator in the dossier for early benefit assessment and – like the IQWiG – concluded that an indirect comparison of secukinumab with the appropriate comparator therapy was not possible due to a lack of suitable studies.
- Consequently, there are no suitable data available overall for the assessment of the additional benefit of secukinumab.
- Overall assessment
- In summary, for adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or evidence from magnetic resonance imaging (MRI), who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), the additional benefit of secukinumab compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
<< List of all resolutions