NICE says Takeda's Entyvio to get NHS funding approval, if discount agreed

A drug to treat a long-term and often distressing bowel condition is being recommended for routine National Health Service (NHS) funding by the medicines cost watchdog for England, the National Institute for Health and Care Excellence (NICE).

In final draft guidance issued today, NICE says that Entyvio (vedolizumab), from Japan’s largest drug company Takeda Pharmaceutical (TYO: 4502), should be recommended as an option to treat moderate to severe active ulcerative colitis (UC), but only if its manufacturer 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.

NICE Centre for Health Technology Evaluation director Carole Longson 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 licensed 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.”

Patients to be reassessed after 12 months' treatment

The draft guidance from the NICE also says that patients receiving vedolizumab should be reassessed after 12 months and that treatment should only continue if there is “clear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.”

Prof Longson noted that “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.