REMSIMA (infliximab) (maladie de Crohn)
Opinions on drugs -
Posted on
Aug 26 2021
Reason for request
Reevaluation
Key points
Favourable opinion for maintenance of reimbursement in:
- the treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies,
- the treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Clinical Benefit
Substantial |
The Committee considers that the clinical benefit of REMSIMA (infliximab) remains substantial in the treatment of Crohn’s disease in adults. |
Clinical Added Value
Comments without ASMR value |
The Committee considers that the data from the studies submitted is not of a nature to modify its assessment of the clinical benefit formulated in its previous opinion of 21 January 2015. |
Documents
English version
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