Novo Nordisk’s GLP-1 heavyweight Wegovy could soon reach many more patients in Britain after the United Kingdom’s cost-effectiveness gatekeeper cleared the drug for use beyond obesity.
The National Institute for Health and Care Excellence (NICE), which serves as the U.K.’s drug price regulator, has given the green light to Wegovy (semaglutide) as a weekly injection to help prevent heart attacks and strokes. The endorsement is separate from Wegovy’s use as a weight loss medication.
Specifically, Wegovy will be offered as an additional treatment on top of other medicines like statins and a reduced-calorie, increased physical activity regimen for certain people at high risk of another serious cardiovascular event, according to an April 1 press release from NICE.
To qualify for a Wegovy prescription under the new recommendation, patients must have previously had a heart attack or stroke, or be living with peripheral arterial disease, according to NICE’s announcement. Patients must also have a body mass index of 27 kg/m² or above (England’s National Health Service classifies obesity as the 30 to 39.9 kg range) and “be willing to make changes to their diet and increase physical activity alongside taking the medication,” NICE explained.
NICE already has a recommendation in place for Wegovy as a treatment for obesity or patients who are overweight, and the British cost watchdog has also signed off on Wegovy’s sister medicine Ozempic in Type 2 diabetes.
Some 1.2 million people in Britain could benefit from the new Wegovy recommendation, NICE pointed out.
The agency based its recommendation on data from Novo’s SELECT trial, in which patients who received Wegovy on top of existing heart meds, including statins, were 20% less likely to suffer a serious cardiovascular event compared to patients who took placebo plus the same background meds. Both groups received standard care throughout the trial, NICE pointed out.
Overall, 6.5% of patients who received Wegovy experienced a major adverse cardiovascular event (MACE) versus 8% of patients on placebo in Novo’s cardiovascular outcomes trial, the company said in a separate release Tuesday.
Notably, NICE flagged that the reduction in risk of heart attack, stroke or cardiovascular death with Wegovy was observed “before significant weight loss occurred,” which the agency said suggests that semaglutide “works directly on the heart and blood vessels, not just through weight loss.”
With Wegovy’s value confirmed by NICE, England’s National Health Service (NHS) said Wednesday that it will make the drug available in the cardio risk reduction indication “within months,” noting that patients with heart and circulatory disease who are overweight should be able to access Novo’s treatment “from this summer.”
“Today’s NICE recommendation for Wegovy is an important step forward for people living with established cardiovascular disease and overweight or obesity,” Sebnem Avsar Tuna, Novo’s U.K. general manager, said in a statement. “It means clinicians in England now have access to a further treatment that NICE has found to be cost-effective, the first and only GLP–1 receptor agonist proven to reduce the risk of heart attack, stroke or cardiovascular death in this high–risk population.”
In its release, Novo said that it’s now “exploring ways to best support the NHS to implement NICE’s recommendations.”
The recommendation win in England comes as Novo attempts to reassert some of its obesity market dominance against Eli Lilly in the U.S. and beyond with the launch of its oral Wegovy pill and a recent FDA nod for a high-dose version of the GLP-1 med’s injectable format.
Meanwhile, the company is facing new pressures in another part of the world, as generics of semaglutide were officially cleared for launch in India late last month.
