Crohn’s disease patients can now get routine access to treatment with Takeda’s biologic Entyvio on the National Health Service in England and Wales after a full green light from cost regulators.

The National Institute for Health and Care Excellence has published final guidelines endorsing Entyvio (vedolizumab) as a treatment for adult patients with moderately to severely active Crohn’s who have either failed or can’t take anti-TNF therapy.

Enytvio is a novel alpha-4 beta-7 integrin antagonist with a different mode of action to other therapies in that it suppresses immune activity only in the gut as opposed to across the whole body, which experts see as “a step change” in the management of the condition.

Indeed, clinical experts consulted by NICE agreed that Entyvio had a more favourable adverse-event profile than other biological treatments because of its ‘gut-specific’ effect and fewer systemic side effects, according to Takeda.

On the efficacy front, clinical data show that, in the maintenance phase, remission at week 52 was significantly higher in patients who received Entyvio compared to placebo (treatment difference: 17.4%), while a sub-group analysis found that of those who had failed one or more anti-TNF, 28.0% were in remission versus to 12.8% on baseline therapies/placebo.

“Getting patients into remission and keeping them there long-term is the primary goal of treatment,” said consultant gastroenterologist Jeremy Sanderson, noting that Entyvio “is an effective and much needed additional treatment option” for patients.

Previously NICE was leaning towards a rejection for the drug because if felt evidence was “too uncertain”. But new data subsequently submitted by Takeda helped convince the Institute otherwise. The probability of Entyvio being cost effective compared with conventional non biological therapy at a maximum acceptable incremental cost effectiveness ratio of £30,000 was found to be 61%.