following an abbreviated submission
adalimumab (Humira®) is accepted for restricted use within NHS Scotland.
Indication under review: is indicated 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 restriction: prescribing by specialists in paediatric gastroenterology.
Treatment of paediatric patients with adalimumab resulted in similar clinical remission and response rates at weeks 26 and 52 to that achieved with adalimumab in severe active Crohn’s disease in adults.
Adalimumab has previously been accepted for use for this indication in adults with severe active Crohn’s disease in NHS Scotland as NHS Healthcare Improvement Scotland advised that NICE Multiple Technology Appraisal No 187 was valid for Scotland.
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Medicine details
- Medicine name:
- adalimumab (Humira)
- SMC ID:
- 880/13
- Indication:
- 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.
- Pharmaceutical company
- AbbVie Ltd
- BNF chapter
- Gastro-intestinal system
- Submission type
- Abbreviated
- Status
- Restricted
- Date advice published
- 08 July 2013