Reason for request
Reevaluation
Key points
Favourable opinion for maintenance of reimbursement in the treatment of:
- moderate to severe, active rheumatoid arthritis in adults, only in combination with methotrexate (MTX), when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate
- active and progressive psoriatic arthritis in adult patients, alone or in combination with MTX, when the response to previous DMARD therapy has been inadequate
- severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy
- severe, active non-radiographic axial spondyloarthritis in adults with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Clinical Benefit
Substantial |
The Committee considers that the clinical benefit of SIMPONI (golimumab)
|
Clinical Added Value
Comments without ASMR value |
The Committee considers that the new data available is not of a nature to modify the assessment of the clinical added value formulated in its previous opinions of 1 February 2012 and 22 June 2016 (CAV V, no clinical added value) in these four indications. |
Documents
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