NICE: Entyvio for Crohn’s Disease Needs More Supporting Evidence

NICE: Entyvio for Crohn’s Disease Needs More Supporting Evidence

The provider of national guidance and advice to improve health and social care in the United Kingdom, the National Institute for Health and Care Excellence (NICE), recently ruled against the approval of Entyvio (vedolizumab) as a treatment for Crohn’s Disease, a form of inflammatory bowel disease (IBD). NICE explained in a draft guidance that the Millennium Pharmaceuticals drug was supported by “uncertain” evidence,  and would not represent good value for the NHS. NICE’s final guidance on Entyvio as a treatment for Crohn’s disease will be published next year, May 2015.

Millennium is a subsidiary of Takeda Pharmaceuticals, Japan’s leading drug company. While Takeda was successful last month after receiving a positive provisional recommendation for Entyvio for maintenance therapy in ulcerative colitis, it appears as though its expanded indication for Crohn’s will need to be backed by more conclusive, favorable findings.

Carole Longson of NICE’s Health Technology Evaluation Centre said Millennium did not give the Appraisal Committee enough evidence demonstrating Entyvio’s notable edge over other available treatments. The committee is obligated to give recommendations only to products proven to be significantly more effective and cost-effective. Longson added, “Unfortunately, because the committee could not be sure that vedolizumab worked at least as well as other currently available drugs they concluded that vedolizumab was unlikely to be a cost-effective use of NHS money. We are disappointed not to be able to say yes to this drug. Fortunately effective drugs are already available within the NHS for Crohn’s disease.”

Millennium has agreed to a patient access scheme with the Department of Health, wherein patients can avail of a small discount on Entyvio. The amount of the discount was not disclosed.

In other news on Crohn’s disease treatments, earlier this month, TxCell SA announced it has begun treating the first Crohn’s Disease patient in Ovasave®’s (ovalbumin-specific autologous Treg cells) Phase IIb “CATS29” clinical trial. Ovasave is TxCell’s leading treatment for this type of IBD, and is currently approved for tests and studies in 6 EU countries. The trial is still ongoing, with preliminary results expected by the end of 2016 to early 2017.