Patients with ulcerative colitis in England and Wales could soon get routine access to Takeda’s Entyvio (vedolizumab) on the National Health Service, gaining access to the world's first gut-selective treatment for the condition.


The National Institute for Health and Care Excellence has issued draft guidelines endorsing the first-in-class treatment for the chronic bowel disease, but only if Takeda provides it at a discounted rate to secure its cost-effectiveness.


There remains significant unmet need for patients with ulcerative colitis, which affects around 146,000 people in the UK, because current treatments do not always work, effectiveness can reduce over time, and some have serious safety concerns. And currently, 78% of emergency surgical admissions result from treatment failures.


The arrival of Entyvio has sparked much excitement among healthcare professionals and patients because, unlike other therapies, it selectively targets the immune system in the gut leaving the rest of the body’s immune defences untouched. This means the drug’s safety profile is similar to placebo, which NICE says offers a step change in the management of UC.


Exciting data

Welcoming the guidelines, Chris Probert, Professor of Gastroenterology at the University of Liverpool, chair of the IBD Section for the British Society of Gastroenterology and vice-chair of the Clinical Advisers Committee for Crohn’s and Colitis UK, noted that Entyvio is the first new class of treatment in over a decade “and the data are very exciting”. 


“For our patients, achieving long-lasting remission with minimal side-effects is the goal of treatment and this has been proven in clinical trials for vedolizumab,” he said.


In December NICE issued draft guidelines rejecting Entyvio for patients with Crohn's disease because the evidence is "too uncertain" and the drug is unlikely to represent good value for money for the NHS.