Sarilumab (2) – Kevzara®
Polyarticular juvenile idiopathic arthritis (pJIA), ≥ 2 years
Characteristics
| Start date | 15.02.2025 – Marketing authorisation: 13.01.2025 |
|---|---|
| Resolution | 07.08.2025 |
| INN | Sarilumab |
| Brand name | Kevzara® |
| Pharm. company | Sanofi-Aventis Deutschland GmbH |
| G-BA Procedure ID | D-1139 |
| ATC code | L04AC14 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | M08.00Unspecified juvenile rheumatoid arthritis of unspecified site, M08.3Juvenile rheumatoid polyarthritis (seronegative), M08.90Juvenile arthritis, unspecified, unspecified site, M08.99Juvenile arthritis, unspecified, multiple sites |
| Alpha-ID codes (AIS) | I119798Juvenile idiopathic arthritis, I126529Juvenile rheumatoid factor-negative polyarthritis, I128130Juvenile rheumatoid factor-positive polyarthritis, I130694Juvenile idiopathic arthritis in several locations |
| Therapeutic area | Musculoskeletal system diseases Juvenile idiopathic arthritis / Enthesitis-related arthritis |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
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Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor-positive or -negative polyarthritis and extensive oligoarthritis) in patients aged 2 years and older who have had an inadequate response to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara can be used as monotherapy or in combination with MTX. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Children and adolescents aged 2 years and older with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have had an inadequate response to previous therapy with conventional synthetic DMARDs | Adalimumab or etanercept or golimumab or tocilizumab, each in combination with MTX; possibly as monotherapy taking into account the respective authorisation status in case of MTX intolerance or unsuitability |
| b) | Children and adolescents aged 2 years and older with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have had an inadequate response to one or more biological DMARDs | Abatacept or adalimumab or etanercept or golimumab or tocilizumab, each in combination with MTX; possibly as monotherapy taking into account the respective authorisation status in the case of MTX intolerance or unsuitability depending on the previous therapy |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (SKYPP) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Uncontrolled study) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
a) Children and adolescents aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to previous treatment with conventional synthetic DMARDs
- An additional benefit is not proven.
- The pharmaceutical manufacturer does not present any relevant study in its dossier for the assessment of the additional benefit of sarilumab compared with the appropriate comparator therapy.
- Overall, the additional benefit of sarilumab compared with the appropriate comparator therapy is not proven for this patient group.
b) Children and adolescents aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to one or more biological DMARDs
- The additional benefit is not proven.
- The pharmaceutical manufacturer does not present any relevant study in its dossier for the assessment of the additional benefit of sarilumab compared with the appropriate comparator therapy.
- Overall, for this patient group, the additional benefit of sarilumab compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Sarilumab (2) | Kevzara® | Sanofi-Aventis Deutschland GmbH | Polyarticular juvenile idiopathic arthritis (pJIA), ≥ 2 years | 1,370–1,480 | 100% additional benefit not proven | |
| Sarilumab (3) | Kevzara® | Sanofi-Aventis Deutschland GmbH | Polymyalgia rheumatica | 10,300–14,200 | 100% additional benefit not proven | |
| Sarilumab (1) | Kevzara® | Sanofi-Aventis Deutschland GmbH | Rheumatoid arthritis (RA) | 87,300–184,470 | 34% Hint for considerable additional benefit |
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