Following its label expansion earlier this month, Medicare on Thursday said it will now cover the use of Novo Nordisk’s Wegovy in patients with overweight or obesity who have preexisting cardiovascular disease.
Pictured: Signage at the Department of Health and Human Services at its headquarters in Washington, DC/iStock, JHVEPhoto
The Centers for Medicare and Medicaid Services announced on Thursday that it will cover Novo Nordisk’s blockbuster weight-loss medication Wegovy (semaglutide) for the reduction of the risk of heart attack, stroke and other related cardiovascular issues in patients who have preexisting heart disease, according to multiple media reports.
Under this new guidance, private insurers running Medicare prescription drug plans—known as Part D—can pay for anti-obesity medications, such as Wegovy and Lilly’s Zepbound (tirzepatide), for additional FDA-approved indications as long as these secondary conditions are covered by the Centers for Medicare and Medicaid Services (CMS).
“CMS has issued guidance to Medicare Part D plans stating that anti-obesity medications that receive FDA approval for an additional medically accepted indication can be considered a Part D drug for that specific use,” an agency spokesperson told Reuters in an email.
However, CMS still does not cover the use of these medications for chronic weight management.
The new CMS guidance comes after the FDA earlier this month approved Novo’s Wegovy to lower the risk of cardiovascular death, heart attack and stroke in overweight and obese adults with heart disease. For this indication, the FDA recommends the use of Wegovy with lifestyle adjustments, such as a reduced-calorie diet and exercise.
The approval was backed by data from the Phase III SELECT study, which evaluated a 2.4-mg dose of Wegovy in more than 17,000 adults with established cardiovascular disease but without a history of diabetes.
SELECT demonstrated a 20% reduction in the risk of major adverse cardiovascular events (MACE), the study’s primary endpoint, after Wegovy treatment. Novo’s GLP-1 receptor agonist also cut the risk of heart attack or myocardial infarction by 28% versus placebo. These heart benefits also became apparent much more quicky after treatment initiation than they would have if these effects were mediated by weight loss alone.
Novo is also positioning semaglutide for renal expansion. In March 2024, the pharma reported data from the Phase III FLOW trial—which it ended ahead of schedule in October 2023 due to strong signals of efficacy—demonstrating a 24% reduction in the risk of kidney disease progression, MACE and kidney death versus placebo in patients with type 2 diabetes and chronic kidney disease.
A report by the Congressional Budget Office (CBO), published on Wednesday, predicts that Medicare could select Wegovy for price negotiations “within the next few years.” This would potentially lower the cost of semaglutide as well as that of other anti-obesity medications, making their insurance coverage more fiscally feasible for the CMS.
At their current price range of $1,000 to $1,300 for a four-week supply, covering Wegovy and other obesity treatments are unsustainable for Medicare and could lead to an increase in the federal government’s deficit over the next 10 years, according to the CBO.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
