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HUMIRA (adalimumab) - Maladie de Crohn chez les adolescents et enfants (≥ 6 ans)
Reason for request
Key points
Approval of retention of reimbursement for the treatment of severe active Crohn’s disease in children and adolescents aged from 6 years having failed to respond to a conventional treatment including first-line nutritional treatment and a corticosteroid and/or an immunomodulatory drug, or in whom these treatments are poorly tolerated or contraindicated.
Clinical Benefit
| Substantial |
The Committee deems that the actual clinical benefit of HUMIRA (adalimumab) remains significant for the treatment of severe active Crohn’s disease, in children and adolescents aged from 6 years having failed to respond to a conventional treatment including a corticosteroid and/or an immunomodulatory drug and a first-line nutritional treatment; or in whom these treatments are poorly tolerated or contraindicated. |
Clinical Added Value
| Comments without ASMR value |
The Committee deems that the new data are not likely to modify the assessment of the clinical added value expressed in the previous opinion of 24 July 2013. |
