The cost watchdog for England and Wales has published findings of an appraisal consultation giving the thumbs up to Schering-Plough/Johnson & Johnson’s Remicade and Abbott Laboratories’ Humira for Crohn’s disease on the NHS.

An appraisal committee for the National Institute for Health and Clinical Excellence has recommended that treatment with Humira (adalimumab) and Remicade (infliximab) be funded on the National Health Service for adults with severe active non-fistulising Crohn’s disease - defined as very poor general health with weight loss and sometimes fever, severe abdominal pain and frequent diarrhoea - who have not responded to or cannot take conventional therapy.

Furthermore, the committee has agreed that Remicade is also a cost-effective treatment option for patients with severe, active fistulising Crohn’s disease as well as for those aged six-17 years with severe, active forms of the illness, as long as they have failed to respond to/are intolerant to standard therapies, such as immunosuppressants and corticosteroids.

While experts consider both drugs to be on par with each other in terms of clinical effectiveness, there is a difference in cost: maintenance therapy with Remicade costs around £12,584, depending on the patient’s body weight, while induction treatment with Humira is around £1,073 and maintenance therapy £9,295 a year. The Institute has stressed that treatment should be started with the less expensive therapy, but pointed out that this may vary between patients “because of differences in the mode of administration and treatment schedules”.

Crohn’s disease is a chronic inflammatory condition affecting the gastrointestinal tract that can cause diarrhoea, abdominal pain, weight loss, malaise, lethargy, anorexia, nausea, vomiting and fever, which it thought to affect around 60,000 people in the UK. According to NICE, between 50% and 80% of patients with Crohn’s will need surgery at some stage, and disease relapses can seriously disrupt normal daily activities and therefore substantially affect quality of life.

No cure, remission key
As there is no cure for Crohn’s disease treatment strategies are currently focused on reducing the symptoms of the illness and extending periods of remission, and clinical trials of Humira and Remicade – both anti-TNF therapies – have demonstrated their ability to first induce remission in patients with active disease and then also prevent relapse in those who have responded to an induction regimen.

However, the appraisal committee has stressed that maintenance therapy for both drugs should be restricted to up to 12 months, at which point the patient should be reassessed, in response to specialists’ concerns over the longer-term effectiveness and safety of TNF-alpha inhibitors.