The maker of Wegovy will bid for a third-time-lucky PBS listing using the TGA’s new indication.
The TGA quietly approved Wegovy (semaglutide) over summer as an adjunct medication for patients with cardiovascular disease and high BMI without diabetes, though the drug remains to be listed for any indication on the PBS.
In December the TGA added this indication under the heading “Reduction in risk of major adverse cardiovascular events”:
“Wegovy is indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with established cardiovascular disease, with a Body Mass Index (BMI) ≥27kg/m2, and without established Type 1 or Type 2 diabetes.”
The decision to approve the Wegovy-branded semaglutide product was based on the SELECT study published in late 2023 – a large international trial, backed by maker Novo Nordisk, involving around 18,000 non-diabetic patients with a BMI of at least 27.
They took weekly injections of either semaglutide or placebo for three years and were followed up for five, in which time 8% of the control group experienced major cardiovascular events (heart attack, stroke or death) compared with 6.5% of those taking the GLP-1 agonist, representing a 20% relative risk reduction.
The semaglutide group achieved average weight loss of nearly 10%, compared with under 1% in the placebo group.
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Professor Stephen Nicholls, director of Monash Health’s Victorian Heart Hospital, who led the Australian arm of SELECT, told media the results confirmed that overweight and obesity were “major drivers of heart disease – on par with cholesterol, blood pressure, diabetes and smoking”, but that the cardiovascular benefits of semaglutide weren’t wholly attributable to weight loss.
“This drug also positively impacts inflammation, blood lipids and blood pressure, which are all crucial in preventing heart attacks and strokes,” he said.
“What this tells us is that if you have heart disease and are overweight or obese, not only are you at a higher risk of another cardiovascular event, but that risk can now be significantly reduced. This is a groundbreaking result for patients.”
Wegovy, which is also approved for weight loss without diabetes, has twice failed to win a PBS listing, unlike its sister drug Ozempic (also semaglutide), which is subsidised for diabetes. As a result, patients without diabetes who wish to take semaglutide for its other benefits are paying up to three times more.
Novo Nordisk has said it will reapply to the PBAC armed with the new TGA indication.
