Secukinumab (7) – Cosentyx®
Enthesitis-related arthritis (ERA)
Characteristics
| Start date | 15.07.2022 – Marketing authorisation: 20.06.2022 |
|---|---|
| Resolution | 05.01.2023 |
| INN | Secukinumab |
| Brand name | Cosentyx® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-843 |
| ATC code | L04AC10 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | M08.89Other juvenile arthritis, multiple sites |
| Alpha-ID codes (AIS) | I120123Enthesitis-associated arthritis |
| DDD | 10 mg P |
| Therapeutic area | Musculoskeletal system diseases Juvenile idiopathic arthritis / Enthesitis-related arthritis |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-associated arthritis in patients 6 years of age and older whose disease has inadequate response to, or intolerance of, conventional therapy.
|
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients aged 6 years and over with active enthesitis-associated arthritis, whose disease has disease has responded inadequately to conventional therapy or who cannot tolerate it. | Therapy according to physician's choice |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (CAIN457F2304) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: no data submitted) |
- Clinical trials
- In the dossier, the pharmaceutical manufacturer refers to the authorisation study CAIN457F2304. This is a withdrawal-design study which, unlike the target population approved for secukinumab, investigates a patient population that has responded to treatment.
Patients aged 6 years and over with active enthesitis-associated arthritis whose condition has responded inadequately to conventional therapy or who are unable to tolerate it
- For patients aged 6 years and over with active enthesitis-associated arthritis whose condition has responded inadequately to conventional therapy or who cannot tolerate it, the additional benefit of secukinumab compared with the appropriate comparator therapy is not proven.
- Overall, for the target population under consideration, there is no suitable study available for either a direct or an indirect comparison of secukinumab with the appropriate comparator therapy.
- On balance, there are no data available that are suitable for a benefit assessment. The additional benefit of secukinumab compared with the appropriate comparator therapy is therefore not proven.
- Overall assessment
- On balance, 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
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