15 June 2010
NICE technology appraisal guidance 187 recommends infliximab (adults and children over 6 years old) or adalimumab▼ (adults only), as treatment options for patients with severe active Crohn’s disease who have not responded to, or are intolerant of, or have contraindications to conventional therapies.
Healthcare professionals involved in the care and treatment of people with Crohn’s disease should familiarise themselves with this technology appraisal (TA 187). Where infliximab or adalimumab▼ are indicated in accordance with this guidance, treatment should normally start with the less expensive drug, taking into account drug administration costs, required dose and product price per dose. The NHS in England and Wales has three months (from May 19th 2010) to start implementing this new guidance.
What is the background to this guidance?
This technology appraisal reviewed the evidence for the treatment of infliximab, previously considered in TA40 (which it replaces) and also reviewed the use of another TNF-alpha inhibitor, adalimumab▼, for the treatment of severe active and severe fistulising Crohn’s disease. The guidance does not consider treatments used in mild to moderate forms of the disease.
What does the guidance say?
The guidance recommends both infliximab and adalimumab▼, within their licensed indications, as treatment options for severe, active forms of disease in adults who have not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments), or are intolerant of, or have contraindications to conventional therapy.
Treatment should normally start with the less expensive drug (taking into account drug administration costs, required dose and product price per dose).
Infliximab is also recommended as an option for people with active, fistulising Crohn’s disease who have not responded to conventional therapy (including antibiotics, drainage and immunosuppressive treatments), or who are intolerant of or have contraindications to conventional therapy.
Treatment with infliximab or adalimumab▼ should be given as a planned course of treatment until treatment failure (including the need for surgery), or until 12 months after the start of treatment, whichever is shorter. People should then have their disease reassessed to determine whether ongoing treatment is still clinically appropriate.
Infliximab is also recommended for treatment of children and young people 6–17 years old with severe, active Crohn’s disease, who have not responded to conventional therapy (including corticosteroids, immunomodulators and primary nutrition therapy), or who are intolerant of, or have contraindications to conventional therapy. As with treatments in adults, the need to continue treatment should be reviewed at least every 12 months.
A NICE guideline for the management of Crohn’s disease is under development and is due for publication in August 2012. Recently updated consensus guidelines are available from the European Crohn’s and Colitis Organisation (ECCO) covering all aspects of diagnosis and management of Crohn’s disease.
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