adalimumab (Humira)

in the absence of a submission from the holder of the marketing authorisation:

adalimumab (Humira®) is not recommended for use within NHS Scotland.

Indication under review: Treatment of moderately active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication.  As a result we cannot recommend its use within NHSScotland.

SMC has previously accepted adalimumab for restricted use for the treatment of severe active Crohn's disease in paediatric patients (6 to 17 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies (SMC 880/13). This advice remains valid.