It is looking unlikely that patients with Crohn’s disease will get National Health Service access to Takeda’s biologic Entyvio (vedolizumab) anytime soon after an early rejection by cost regulators.

The National Institute for Health and Care Excellence has issued draft guidelines rejecting the drug’s use on grounds that the evidence “is too uncertain” and that it is unlikely to represent good value for the NHS, even taking a proposed Patient Access Scheme into account.

In a mixed patient population, the incremental cost effectiveness ratio presented by the company for Entyvio compared with conventional non-biological therapy was £62,900 per QALY gained, and thus far above what is normally considered value for money. 

Around 115,000 people in the UK have Crohn’s, a long-term condition that causes inflammation of the lining of the digestive system leading to symptoms such as diarrhoea, abdominal pain, extreme tiredness and unintended weight loss.

Carole Longson, NICE Health Technology Evaluation Centre Director, said the Institute is disappointed not to be able to recommend Entyvio in this setting, but also stressed that effective drugs are already available within the NHS to treat the condition.

Entyvio recently received a provisional yes from NICE as the first biologic maintenance therapy for ulcerative colitis.