The National Institute for Health and Care Excellence (NICE), the provider of national guidance and advice to improve health and social care in the United Kingdom, published a draft guidance advising against the use of Entyvio by patients in the National Health System. The drug developed by Millennium Pharmaceuticals is intended for the treatment of Crohn’s disease, a type of inflammatory bowel disease (IBD).
The decision to recommend against the use of Entyvio by NHS patients is based on uncertain evidence, as well as on the unlikely nature that the drug would represent good value, as announced in a press release. In addition, NICE finds particularly concerning the uncertainty whether Entyvio is not as effective as other treatments that are currently available on the market.
“Unfortunately the maker of vedolizumab did not give the committee enough information to show how well it worked when compared to other treatments,” explained the director of NICE’s health technology evaluation centre, Professor Carole Longson. “We have to be sure that a drug is both effective and cost-effective before it can be recommended.”
Entyvio is a drug therapy designed to treat adults who suffer from moderately to severely active Crohn’s disease, and who have responded inadequately, lost response to, or do not tolerate conventional therapies or a tumor necrosis factor-alpha inhibitor. The company had tried to defend against the first indications that NICE would rule against the drug by agreeing on lowering the drug’s price through a patient access scheme.
In addition, the therapeutic option is a breakthrough treatment, as the available treatments target the inflammatory process in order to stop it, reduce the burden of the symptoms and refrain surgery, while Entyvio aims to target the underlying cause of the disease.
The European Commission approved Entyvio in May 2014 for the treatment of ulcerative colitis and Crohn’s disease in adults, and in July the U.S. Food and Drug Administration also approved it for the commercialization in the United States. However, United Kingdom authorities have been reluctant to support its use in the NHS.
NICE’s Health Technology Evaluation Centre has already released a first opinion of the drug stating that Millennium hadn’t given the Appraisal Committee enough evidence demonstrating Entyvio’s notable edge over other available treatments and that the committee is obligated to give recommendations only to products proven to be significantly more effective and cost-effective. A final guidance is expected to be published by NICE next May.
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