Reason for request

Reevaluation

Key points

Favourable opinion for maintenance of reimbursement in the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.


Clinical Benefit

Substantial

The Committee considers that the clinical benefit of REMICADE (infliximab) remains substantial in ulcerative colitis.


Clinical Added Value

Comments without ASMR value

The Committee considers that the data from this study is not of a nature to modify its assessment of the clinical benefit formulated in its previous opinion of 7 May 2014.


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Évaluation des médicaments