Novo Nordisk’s GLP-1 flagship Wegovy could soon reach more patients in the UK after the country’s cost-effectiveness gatekeepers cleared the drug for use beyond obesity.
The National Institute for Healthcare Excellence (NICE), which acts as the UK’s drug price regulator, has given the green light to Wegovy (semaglutide) as a weekly injection to prevent heart attacks and strokes. This approval is separate from Wegovy’s use as a weight loss drug.
Specifically, Wegovy will be offered as an add-on treatment in addition to other drugs such as statins and calorie-reduction and exercise-increase therapy for certain people at high risk of other serious cardiovascular events, according to NICE’s April 1 press release.
To be eligible to be prescribed Wegovy under the new recommendations, patients must have had a previous heart attack or stroke, or have peripheral artery disease, NICE said in a statement. Patients also need to have a body mass index of at least 27kg/sqm (the UK’s National Health Service classifies obesity as a range of 30 to 39.9kg) and be “willing to change their diet and increase their physical activity while taking the medication”, NICE said.
NICE has already recommended Wegovy for the treatment of obese and overweight patients, and the UK cost watchdog has also approved approval of Wegovy’s sister drug Ozempic for type 2 diabetes.
NICE noted that around 1.2 million people in the UK could benefit from Wegovy’s new advice.
The agency based its recommendations on data from Novo’s SELECT trial. In the trial, patients who received Wegovy in addition to existing heart medications, including statins, were 20% less likely to suffer a serious cardiovascular event compared to patients who received the same background drug as a placebo. NICE noted that both groups received standard treatment during the trial.
In a separate release on Tuesday, the company announced that overall in Novo’s cardiovascular outcomes trial, 6.5% of patients receiving Wegovy experienced a major serious cardiovascular event (MACE), compared to 8% of patients receiving a placebo.
Notably, NICE reported that the reduced risk of heart attack, stroke, or cardiovascular death in Wegovy was seen “before significant weight loss occurred,” suggesting that semaglutide “acts directly on the heart and blood vessels, not just on weight loss,” the agency said.
Following NICE’s confirmation of Wegovy’s value, the UK’s National Health Service (NHS) announced on Wednesday that it plans to make the drug available for heart disease risk reduction “in the coming months”, noting that patients who are obese and suffer from heart and circulatory disease should be able to receive Novo’s treatment “from this summer”.
“Today’s NICE recommendation for Wegovy is an important step forward for people living with pre-existing cardiovascular disease or being overweight or obese,” Novo UK general manager Sebnem Avsar Tuna said in a statement. “This means that clinicians in the UK now have access to a further treatment that NICE has recognized as cost-effective – the first and only GLP-1 receptor agonist proven to reduce the risk of heart attack, stroke and cardiovascular death in this high-risk population.”
Novo said in a release that it is currently “exploring how best to support the NHS in implementing NICE’s recommendations”.
The endorsement win in the UK comes as Novo looks to reassert some of its obesity market dominance over Eli Lilly in the US and other countries with the launch of its oral pill Wegovy and the FDA’s recent nod to a higher-dose version of the GLP-1 drug in injectable form.
Meanwhile, the company is facing new pressure in another part of the world, as generic semaglutide was officially approved for sale in India late last month.
