NICE has recommended Entyvio (vedolizumab) to treat moderate to severe ulcerative colitis in final draft guidance.
The bowel condition drug will be licensed as a treatment for adult patients with the condition who have had an inadequate response with, or lost response to, or were intolerant to conventional therapy or a tumour necrosis factor-alpha antagonist.
The recommended dosage is 300mg given by intravenous infusion at the start, two and six weeks and then every eight weeks following.
Professor Carole Longson, director of NICE centre for health technology evaluation, commented: “Ulcerative colitis is a long-term and distressing condition for many thousands of people. It can have a serious impact on a person’s quality of life.
“Vedolizumab works in a different way to other treatment options [by] targeting the immune system in the gut rather than the whole body – and as such marks another approach to manage the condition.”
The draft guidance also states that patients receiving Entyvio should be reassessed after twelve months and that treatment should only continue if there is ‘clear evidence of ongoing clinical benefit’.
The drug is to be recommended for routine NHS funding if Takeda can supply the treatment as an agreed discounted value. The current full cost for Entyvio is £2,050 per 300mg vial, but a patient access scheme is in negotiation.
Ulcerative colitis affects around 146,000 people in the UK. It is thought to occur when the body’s immune system attacks healthy tissue in the bowel, causing it become inflamed. The condition often causes small, pus-filled ulcers on the colon’s lining, bloody diarrhoea and abdominal pain
At the start of the year, NICE issued draft guidance recommending against the use of Entyvio for patients with Crohn’s disease due to concerns around uncertain evidence and its value to the NHS.