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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 INFLECTRA (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 this study is not of a nature to modify its previous assessment of the medical benefit formulated in its previous opinion of 21 January 2015. |
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