Takeda gets NICE nod for bowel treatment
pharmafile | March 13, 2015 | News story | Sales and Marketing | NHS, NICE, Takeda, enyyvio, vedolizumab
Takeda’s Entyvio becomes the first NICE approved gut-selective treatment for UK patients with ulcerative colitis (UC) – a long-term condition causing the colon and rectum to become inflamed.
Entyvio (vedolizumab) has been recommended as an option to treat moderate to severely active UC, but only if Takeda can supply it at an agreed discounted rate.
The Japanese firm has agreed a patient access scheme with the Department of Health whereby it will provide the drug – usually priced at £2,050 per 300mg vial – to the NHS at a discount.
“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,” says Professor Carole Longson, who is the director of the NICE centre for health technology evaluation.
“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,” she adds.
The 30-minute intravenous infusion works by blocking the entry of white blood cells in the gut to help reduce inflammation and associated symptoms – such as urgent bloody diarrhoea, rectal bleeding and extreme fatigue.
The green light from NICE is down to trials that reported improvements in quality of life were greater with Entyvio than placebo. Almost 50% of people participating in the studies responded to the drug in six weeks.
Of those patients that responded, 42% were in remission at one year, compared to 16% on baseline therapies and placebo.
Longson concluded: “The only 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.”
Ulcerative colitis affects an estimated 146,000 people in the UK – 23,000 of which are under 30 – and is thought to occur when the body’s immune system wrongly attacks healthy tissue in the bowel, causing it to become inflamed.
Tom Robinson
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