Secukinumab (8) – Cosentyx®
Juvenile psoriatic arthritis (PA), ≥ 6 years
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-844 |
| ATC code | L04AC10 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | L40.5Arthropathic psoriasis |
| DDD | 10 mg P |
| Therapeutic area | Skin diseases Psoriatic Arthritis (PA) |
| 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 juvenile psoriatic arthritis in patients 6 years of age and older whose disease has disease has responded inadequately to, or is intolerant of conventional therapy.
|
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients aged 6 years and over with active juvenile psoriatic 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, examines a patient population that has responded to treatment.
Patients aged 6 years and over with active juvenile psoriatic arthritis whose condition has responded inadequately to conventional therapy or who cannot tolerate it
- For patients aged 6 years and over with active juvenile psoriatic 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, there is no suitable study available for the target population under consideration that allows 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.
Courtesy translation only, please refer to the German original.
Associated procedures
<< List of all resolutions