|NICE's Carole Longson|
Takeda got a positive recommendation from the U.K.'s cost gatekeeper for its inflammatory bowel disease drug Entyvio, but the National Institute for Health and Care Excellence (NICE) tacked on a condition to its approval.
The cost watchdog gave its thumbs-up to Entyvio to treat moderate to severely active ulcerative colitis as long as Takeda offers the drug at a discount. Entyvio costs £2,050 ($3,022) for a 300-mg vial, but the company agreed to a patient access scheme with the Department of Health to provide the drug to the NHS at a reduced price, NICE said in a statement. Takeda and NICE are staying mum about the size of the discount.
Entyvio represents a "welcome and effective alternative" to other drugs on the market to treat ulcerative colitis, Carole Longson, Director of NICE Centre for Health Technology Evaluation, said in a statement. Some patients cannot tolerate conventional therapy or TNF-alpha inhibitors, and other treatment options such as corticosteroids often come with severe side effects. Entyvio, a 30-minute intravenous infusion, blocks the entry of white blood cells in the gut to help reduce inflammation and symptoms including rectal bleeding and extreme fatigue.
NICE in draft guidance said patients taking Entyvio should be reassessed after 12 months and that treatment should only continue if there is "clear evidence of ongoing clinical benefit." The cost gatekeeper expects to publish final guidance for the drug later this year.
A positive recommendation from NICE comes at a transitional moment for Takeda, as it looks to swing its numbers northward and generate growth in light of declining profits. The company last month said it was expecting a nearly 40% fall in net income to about $548 million for the current fiscal year, following a 28% decline for the previous fiscal year after the drugmaker's blockbuster diabetes drug, Actos, lost patent protection.
But Christophe Weber, who takes over the CEO role at Takeda next month, is forging ahead with plans to jumpstart the company's lagging fortunes. Part of the push involves focusing on gastrointestinal meds, an area ripe for growth. Last year, the drugmaker won FDA and EU approval for Entyvio, eyeing a market forecast to hit $1 billion in peak sales by 2020. Takeda is also looking to oncology and emerging markets for expansion, snatching up a portfolio of drugs from Turkey's Neutec for $121 million last month and revealing positive data on ixazomib, its top oncology prospect in line to succeed blockbuster Velcade.
- read the NICE statement
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