GLP-1s hit new milestone: Wegovy approved for cardiovascular issues 

The FDA recently approved a new indication for Wegovy, a milestone event in what many in the industry refer to as the era of the GLP-1s.

Wegovy's new approved indication is to reduce the risk of serious cardiovascular events, including death, heart attack and stroke, in adults with cardiovascular disease who are either obese or overweight. Wegovy, which contains the same active ingredient as the diabetes treatment Ozempic, was previously approved by the FDA in 2021 for chronic weight management.

The new cardiovascular indication isn't expected to significantly increase the number of individuals who potentially qualify for the drug based on the FDA label, but it may generate further increased interest in treatment from patients and providers. And the increased interest is likely to put new pressure on employers to cover it. Further contributing to the drug’s visibility, Medicare recently announced that Medicare Part D plans will be allowed to cover Wegovy for its new indication, even though federal law prohibits Medicare from covering weight loss drugs. An estimated 4.7% of the US adult population could meet the criteria for Wegovy's new cardiovascular indication.  

The clinical trials that supported the new indication showed a 20% relative risk reduction in major adverse cardiovascular events among study participants who used Wegovy. Over the 5-year study period, 6.5% of people who used Wegovy for an average of 33 months experienced a major cardiovascular event, compared to 8% of people who received a placebo. While the reduction is certainly meaningful, a prescription for Wegovy should not be seen as the only tool in the toolbox for managing cardiovascular risk factors.

A new reason to reevaluate GLP-1 strategy

The new indication for Wegovy presents an important opportunity for employers to re-evaluate their current and future GLP-1 strategy. Key questions for employers to consider and discuss with their carriers and PBMs include:

• What utilization management or prior authorization criteria will apply to Wegovy prescribed for cardiovascular disease?
• Where does Wegovy fit within a holistic approach to cardiovascular disease management that includes both drug and non-drug therapy?
• If the plan currently excludes coverage for weight-loss drug therapy, will that exclusion continue to apply for Wegovy's new indication? If it doesn't – meaning, Wegovy will be covered for the new indication but not for weight loss – does the existing weight-loss benefit exclusion continue to be aligned with the employer's philosophy on coverage?

More GLP-1 indications on the way

Multiple studies are underway to assess the safety and utility of GLP-1 drugs to treat other conditions beyond weight management and cardiovascular disease. We could see future approvals for conditions like sleep apnea, metabolic dysfunction associated steatohepatitis (also known as fatty liver disease), or even early Alzheimer's. As the portfolio of diseases treated by GLP-1s continues to expand, utilization and spend will continue to grow. Employers need to be prepared with a consistent and equitable strategy to manage costs and utilization for these popular and costly medications.