A drug to treat a long-term and often distressing bowel condition is being recommended for routine NHS funding by the National Institute for Health and Care Excellence.
In final draft guidance, published today, NICE said vedolizumab (Entyvio) should be recommended as an option to treat moderate to severely active ulcerative colitis.
“This is the first new class of treatment in over a decade and the data is very exciting, as it provides a real step change in treatment”
However, it added that patients receiving vedolizumab should be reassessed after 12 months and that treatment should only continue if there was “clear evidence of ongoing clinical benefit”.
The full cost of vedolizumab for the NHS is £2,050 per 300mg vial (excluding VAT). However, the drug’s manufacturer Takeda has agreed a patient access scheme with the Department of Health whereby it will provide vedolizumab to the NHS at an undisclosed discount.
Final guidance for the NHS about the use of vedolizumab as a routine treatment for ulcerative colitis will be published by NICE later this year.
Ulcerative colitis, which affects an estimated 146,000 people in the UK, is thought to occur when the immune system wrongly attacks healthy tissue in the bowel, causing it to become inflamed.
“Vedolizumab works in a different way to other treatment options for ulcerative colitis”
Symptoms can include pus-filled ulcers on the colon’s lining, bloody diarrhoea, abdominal pain and an urgent need to go to the toilet.
Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said vedolizumab would be a “welcome and effective alternative” to existing treatments for patients with the condition.
“Vedolizumab is licenced to treat people when conventional therapy or… TNF-alpha inhibitors either doesn’t work well, has stopped working or can’t be tolerated,” she said.
“For these patients, the other options are commonly treatments such as corticosteroids, which may have severe side effects, or surgery, which can have a profound effect on fertility that many don’t want to endure,” said Professor Longson.
She added: “Vedolizumab works in a different way to other treatment options for ulcerative colitis – targeting the immune system in the gut rather than the whole body – and as such marks another approach to manage the condition.”
Dr Karen Kemp, an inflammatory bowel disease nurse practitioner at Manchester Royal Infirmary, said: “This is the first new class of treatment in over a decade and the data is very exciting, as it provides a real step change in treatment.”
The charity Crohn’s and Colitis UK described the NICE approval as of “major significance for people with ulcerative colitis”.
Helen Terry, its director of policy and public affairs, said she was “delighted” there would be an “additional and promising” new treatment available, as current options were “very limited”.
“Previously, people in this situation had little other option except surgery, with all the implications that this can bring,” she noted.