NICE Recommends Takeda’s Entyvio for Ulcerative Colitis

Takeda’s monoclonal antibody Entyvio got a tentative green light from the UK’s health cost watchdog as a treatment for severe colitis, paving the way for a final consultation and adoption by the National Health Service.

The National Institute for Health and Care Excellence recommended Entyvio (vedolizumab) for patients with active or severely active ulcerative colitis who have not benefited from TNF-alpha inhibitors or can’t tolerate drugs of that class, but said Takeda must provide the drug at an agreed discount.

The final draft recommendation also requires that patients be reassessed after one year of treatment and those who are in remission be taken off treatment, unless symptoms recur, and that patients continue to be reevaluated on an annual basis.

With these provisions, Entyvio’s cost was less than $29,572 per year, significantly lower than comparator drugs such as AbbVie’s Humira (adalimumab) and cheaper than surgery and postsurgical care, NICE says. The institute’s upper limit is usually between $29,572 and $44,358.

Many ulcerative colitis patients are given immunosuppressants that work systemically, leaving them vulnerable to infections and cancers. By contrast, Entyvio affects only the digestive tract.

Entyvio is also indicated for Crohn’s disease in the UK. Read the final draft guidance at www.fdanews.com/03-16-15-NICEUCguidance.pdf. — Lena Freund