In final draft guidance, NICE says vedolizumab (also called Entyvio) should be recommended as an option to treat moderate to severely active ulcerative colitis, but only if its manufacturer (Takeda) can supply the treatment at an agreed discounted rate.
Ulcerative colitis affects an estimated 146,000 people in the UK. The condition is thought to occur when the body’s immune system wrongly attacks healthy tissue in the bowel, causing it to become inflamed. It can cause small, pus-filled ulcers on the colon's lining as well as 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: “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 is licenced to treat people when conventional therapy or a type of treatment called TNF-alpha inhibitors either doesn’t work well, has stopped working or can’t be tolerated. 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. Vedolizumab will be a welcome and effective alternative.”
The draft guidance from NICE also says that patients receiving vedolizumab should be reassessed after 12 months and that treatment should only continue if there is “clear evidence of ongoing clinical benefit”.
Professor Longson said: “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.”
Final guidance for the NHS about the use of vedolizumab as a routine treatment for ulcerative colitis is expected to be published by NICE later this year.
For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.
Notes to Editors
Explanation of terms
- The full cost of vedolizumab for the NHS is £2,050 per 300mg vial (excluding VAT; ‘British national formulary’ [BNF] edition 69). However, the pharmaceutical company has agreed a patient access scheme with the Department of Health whereby it will provide vedolizumab to the NHS at a discount. The level of this discount is commercial in confidence.
About the guidance
The final draft guidance recommends vedolizumab, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults only if the company provides vedolizumab with the discount agreed in the patient access scheme.
The guidance also recommends that:
- vedolizumab should be given until it stops working or surgery is needed.
- at 12 months after the start of treatment, people should be reassessed to see whether treatment should continue. Treatment should only continue if there is clear evidence of ongoing clinical benefit.
- for people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse.
- people who continue vedolizumab should be reassessed at least every 12 months to see whether continued treatment is justified.
Vedolizumab is licensed as a treatment for ‘adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, or lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha antagonist’.
The recommended dosage of vedolizumab is 300mg given by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter.
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