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 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 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.

Adalimumab remains a treatment option for adults with severe active Crohn's disease whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments), or who are intolerant of or have contraindications to conventional therapy, in line with the NICE (Multiple) Technology Appraisal Guidance No 187.  Healthcare Improvement Scotland advises that the recommendations are as valid for Scotland as for England and Wales.