NICE recommends vedolizumab for Crohn’s Disease

The National Institute for Health and Care Excellence (NICE),  the medicines cost-effectiveness body for England and Wales, has recommended Takeda’s Entyvio (vedolizumab) for use on the NHS for adults with Crohn’s Disease (CD).

Vedolizumab is the first gut-selective treatment for CD. NICE recommends vedolizumab for adults with moderately to severely active CD who have either failed, or were intolerant or contraindicated to, an anti-TNF (tumour necrosis factor-alpha antagonist). NICE recognises vedolizumab as an innovative, cost-effective treatment that provides remission from symptoms. CD is a chronic condition that affects around 115,000 people in the UK. The annual UK cost per CD patient in relapse is estimated to be £10,513.

Vedolizumab is a 30-minute intravenous infusion given every eight weeks. It works selectively in the gut to help block the entry of white blood cells, reducing inflammation and associated symptoms, such as malnutrition, weight loss, urgent and frequent diarrhoea and rectal bleeding. These distressing symptoms can leave people housebound and have a wide-ranging and devastating impact on mental health, relationships and employment.

Crohn’s and Colitis UK welcomes this recommendation and highlights that vedolizumab could make a fundamental difference in enabling some people with CD to get on with their lives.3

Dr Jeremy Sanderson, Consultant Gastroenterologist, commented, “Getting patients into remission and keeping them there long-term is the primary goal of treatment. For our patients, active disease has a huge negative impact across all aspects of daily life. Vedolizumab is an effective and much needed additional treatment option for patients with Crohn’s Disease.”

Vedolizumab has a more favourable adverse-event profile than existing biological treatments

As part of its decision, NICE recognises that vedolizumab works differently to existing treatments for CD and considered this to be an innovation; selectively targeting the immune system in the gut. Importantly, clinical experts consulted by NICE felt that vedolizumab has a more favourable adverse-event profile than existing biological treatments because of this ‘gut-specific’ effect and fewer systemic side effects.

Commenting on the recommendation, Adam Zaeske, Managing Director of Takeda UK and Ireland, said,“We are pleased to receive final NICE guidance for vedolizumab in CD as this brings patients a step closer to a much needed additional treatment option. Vedolizumab has been recommended by NICE and accepted by SMC for restricted use in CD, and across its full licenced indication in UC, within 18 months of EMA licence, which demonstrates both the treatment innovation of vedolizumab and our commitment to addressing unmet patient needs.”

Today’s decision is the second positive NICE ruling for vedolizumab – on 5 June 2015, NICE published positive final guidance on vedolizumab for adults with moderately to severely active UC across its full licenced indication.