WIREDGOV

In final draft guidance published today (4 March) NICE has recommended infliximab and adalimumab as treatment options for people with severe, active Crohn’s disease whose condition has not responded to conventional therapy, or who are intolerant of or have contraindications to conventional therapy.

Crohn’s disease is a chronic inflammatory condition of unknown cause affecting the gastrointestinal tract (gut). It is estimated that around 60,000 people in the UK have the disease, with approximately 3,000 (5%) having the most severe forms of the condition. The disease causes parts of the gastrointestinal tract to become inflamed, causing diarrhoea, pain in the abdomen, weight loss and tiredness. Ulcers can form in the wall of the gastrointestinal tract and when they heal the scar tissue makes the tract narrower. Sometimes Crohn’s disease causes the formation of abnormal passageways (fistulas) between parts of the intestine, or between the intestine and the skin. It can also affect other parts of the body, such as the eyes or the joints. People with Crohn’s disease can have recurrent attacks - that is, they have times when their disease flares up and in between they have periods of remission.

The draft guidance from NICE recommends infliximab and adalimumab as treatment options for adults with severe, active Crohn’s disease that has not responded to conventional treatment, or who are intolerant of or have contraindications to conventional therapy. Treatment should normally be started with the less expensive drug (taking into account drug administration costs, required dose and product price per dose). Infliximab is also recommended for adults with active, fistulising Crohn’s disease, and for children and young people aged 6-17 years old with severe, active Crohn’s disease.

Dr Carole Longson, Health Technology Evaluation Centre Director said:

“Unfortunately there is no known cure for this debilitating condition, so treatment is limited to controlling and easing symptoms.  Our review of the evidence indicates that infliximab and adalimumab are clinically and cost effective treatment options for some people with the most severe forms of Crohn’s disease, and for whom conventional treatments have failed or are not an option. This draft final decision will be welcome news to those who are affected”.     

NICE has not yet issued final guidance to the NHS. Consultees now have the opportunity to appeal against the proposed guidance.

The draft guidance is available from 10.00am GMT on Thursday 4 March on the NICE website at http://guidance.nice.org.uk/TA/Wave13/78/FAD

Consultees have until Thursday 18 March 2010 to submit an appeal.

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.  Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.  The NHS will then have three months to start implementing this new guidance.  Subject to any appeals being received, guidance is expected to be published in May 2010.