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Reason for request
Key points
Favourable opinion for maintenance of reimbursement, in combination with methotrexate, in the treatment of moderate to severe active rheumatoid arthritis in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (α TNF) antagonists. In these patients, ROACTEMRA can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Clinical Benefit
| Substantial |
The clinical benefit of ROACTEMRA (tocilizumab) remains substantial in the treatment of moderate to severe active rheumatoid arthritis in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. |
Clinical Added Value
| Comments without ASMR value |
The Committee considers that the new data available is not of a nature to modify its last assessment of the clinical added value formulated in its opinion of 11 May 2016 in rheumatoid arthritis. |
