The UK’s cost-effectiveness agency has published a draft guidance initially recommending drug Remicade (infliximab) for use in England to treat severe acute ulcerative colitis – but only in patients who can not use ciclosporin.

This is a blow for developer Johnson & Johnson and marketer Schering-Plough, who had hoped to have a wider base of patients for the drug, which has already been approved for treating psoriasis and rheumatoid arthritis and is a blockbusting earner in the US.

According to the draft guidance, The UK National Institute for Health and Clinical Excellence (NICE) has recommended that Remicade be prescribed via the National Health Service (NHS) in England to treat acute exacerbations of ulcerative colitis, but only in patients in whom ciclosporin is contraindicated. Ciclosporin is an existing therapy for the disease.

Outside of this criterion, NICE recommended that Remicade be limited to clinical trials.

The guidance does not spell the end for the pharma companies, as it is only in draft form.

In a statement released by Schering-Plough, the US company said: “Schering-Plough is reviewing these initial recommendations which suggest an alternative option for a number of UC patients by helping them to achieve and maintain full remission and ultimately reduce the need for surgery.”

On speaking to PharmaTimes Online, Schering-Plough UK product communications manager Jim Baxter said the company, once reviewing the recommendations, would reply to NICE with its comments.

He declined to comment further on the possible content of the comments.

The NICE decision
NICE based its initial decision on two randomised control trials comparing Remicade with a placebo and two trials assessing the benefits of ciclosporin. The end point of the trials was the avoidance of colectomy.

The Evidence Review Group and the Appraisal Committee reviewed the data and agreed there was a lack of a comparative trial between Remicade and ciclosporin, thereby making it difficult to compare clinical and cost-effectiveness. A mixed-treatment comparison model was developed to compare the two drugs in terms of colectomy and results showed that Remicade-treated patients were more likely to require a colectomy at three to 12 months, though a genuine comparison was virtually impossible the groups acknowledged.

Schering-Plough also failed to include data on adverse events and mortality, it was noted.

Schering-Plough estimated Remicade’s cost-effectiveness to be £11,589 ($21,865) per additional quality-assured life year (QALY) gained compared with standard care, £18,425 per additional QALY gained compared with ciclosporin, and £13,407 per additional QALY gained compared with surgery. These figures were adjusted by the Evidence Review Group to £12,307, £19,922 and £14,427 respectively.

NICE has called for further research and to directly compare Remicade with ciclosporin.

A final guidance on Remicade as a treatment for acute exacerbations of severely active ulcerative colitis is expected in September. A planned revision of the guidance will occur in 2011.