Wegovy received FDA approval last month for a new indication to reduce the risk of cardiovascular events in adults with obesity or overweight.

CI’s Three Key Takeaways: 

  • Medicare will cover the weight-loss drug Wegovy (semaglutide) for certain patients at an increased risk of cardiovascular events such as heart attacks and strokes. 
  • The FDA recently approved a new indication for Wegovy to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are obese or overweight. This approval was based on a clinical trial that demonstrated Wegovy’s effectiveness in significantly lowering these risks compared to a placebo.
  • Following these developments, dozens of health organizations have advocated for the continued expansion of Medicare coverage for anti-obesity medications, including Wegovy, to help advert cardiovascular disease before it arises. They emphasize that obesity significantly increases the risk of developing cardiovascular diseases, which are the leading cause of death in the United States.

The Centers for Medicare and Medicaid Services (CMS) announced that it would allow health plans under Medicare Part D to cover Wegovy and other weight-loss medications if they receive Food and Drug Administration (FDA) approval for an additional medically accepted indication.

Last month, Wegovy received FDA approval for a new indication for use to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight. 

“Wegovy is now the first weight-loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” says John Sharretts, MD, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research, in a release. “This patient population has a higher risk of cardiovascular death, heart attack, and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”

CMS notes that in instances when an anti-obesity medication receives approval for an additional medically accepted indication during the contract year, Part D sponsors may include such drugs on their current Part D formularies as they can be covered under Part D for that use. 

Wegovy Reduces Heart Risks in Clinical Trial

Wegovy’s efficacy and safety for this new indication were studied in a multi-national, multi-center, placebo-controlled double-blind trial that randomly assigned over 17,600 participants to receive either Wegovy or placebo. 

Participants in both groups also received standard-of-care medical treatment (eg, management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity). Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke), which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received placebo.

Obesity or overweight affect approximately 70% of American adults. Obesity and overweight are serious health issues that increase the risk for premature death and a variety of health problems, including heart attack and stroke. 

Advocacy for Wider Anti-Obesity Drug Coverage Amid Cardiovascular Crisis

In a letter addressed to CMS administrator Chiquita Brooks-LaSure, 44 organizations across various disease states commended CMS’s decision to cover anti-obesity medications for patients with existing, high-risk cardiovascular disease. 

The letter emphasized, however, the need to expand coverage of anti-obesity medications for primary use in treating obesity.

According to the Centers for Disease Control and Prevention, obesity significantly increases individuals’ risk of developing cardiovascular disease, which is responsible for almost 700,000 deaths annually, making it the nation’s leading cause of death. This reality, the group asserts, underscores the necessity to deploy effective obesity treatments to prevent cardiovascular complications. 

Recent research has demonstrated semaglutide’s efficacy as an obesity treatment, having shown meaningful weight loss and improvements in metabolic parameters (like blood pressure, cholesterol levels, and glycemic control) in patients.

“We recognize the critical link between obesity, cardiovascular disease, and other comorbidities,” says Dharmesh Patel, MD, FACC, cardiologist in north Mississippi and president of the Partnership to Advance Cardiovascular Health, in a release. “By expanding coverage for semaglutide and other [anti-obesity medications], CMS has an immense opportunity: In concert with lifestyle modifications, these medications can help many individuals avert [cardiovascular disease] before it arises. We need to do more to support prevention when dealing with America’s number-one killer—heart disease. CMS can take a major step toward that goal by expanding coverage for semaglutide.”

The cosigning organizations are hopeful that CMS will take steps to expand coverage for semaglutide and other anti-obesity medications, preventing patients from developing life-threatening diseases.

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