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)

  • remains substantial, in combination with methotrexate (MTX), in the treatment of moderate to severe, active rheumatoid arthritis in adults, when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.

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.


Contact Us

Évaluation des médicaments