NICE rejects Takeda Crohn’s disease drug
pharmafile | December 23, 2014 | News story | Sales and Marketing | Crohn’s disease, Entyvio, NHS, NICE, Takeda, crohn's disease, vedolizumab
Takeda has seen its treatment for people with Crohn’s disease Entyvio rejected by NICE in an initial appraisal.
The healthcare guidance body decided not to recommend Entyvio (vedolizumab) as a treatment for people with moderate to severe Crohn’s disease.
Its appraisal committee reviewed Takeda’s submission and deciding that “the evidence for the drug is too uncertain” and that “the drug was not likely to represent good value for the NHS”.
Professor Carole Longson, director of the NICE health technology evaluation centre, says: “Unfortunately the maker of Entyvio did not give the committee enough information to show how well it worked when compared to other treatments. We have to be sure that a drug is both effective and cost-effective before it can be recommended.
“Because the committee could not be sure that Entyvio worked at least as well as other currently available drugs, they concluded that Entyvio 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.”
Entyvio is a biologic therapy licensed for Crohn’s disease and ulcerative colitis. Takeda’s list price for the drug is £2,050 per 300mg vial for ongoing treatment, although the company has agreed a patient access scheme with the Department of Health.
The news is as a blow for the Japanese firm who had been buoyed in November when it gained a provisional yes from NICE, after its draft guidance approved Entyvio as the first maintenance treatment for people with moderate to severe active ulcerative colitis.
Crohn’s disease is a long-term condition that affects about 115,000 people in the UK. Currently there are no NICE-approved offerings that are specifically licensed as a maintenance therapy for people with Crohn’s disease. Treatments for maintaining remission and managing the symptoms include steroids, immunosuppressants and cytotoxic agents.
Final guidance on the use of Entyvio as a treatment for Crohn’s disease is expected to be published in May next year.
Lilian Anekwe
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