Navigating the New Frontier: FDA's Approval of Wegovy for Cardiovascular Risk Reduction
Dr. Edo Paz
SVP, Medical Affairs at Hello Heart & Cardiologist at White Plains Hospital
Key Takeaways:
- The FDA approval on March 8, 2024, extends Wegovy's use to reduce cardiovascular risk in overweight or obese adults with a history of CVD, alongside existing weight management indications.
- The approval prompts insurers, including Medicare, to reconsider coverage for Wegovy and similar drugs, impacting self-funded employers and health plans.
- Comprehensive education around the importance of lifestyle interventions and enhanced medication adherence will be instrumental for long-term success with a GLP-1
March 8, 2024 marked a pivotal moment in the management of cardiovascular disease (CVD) as the U.S. Food and Drug Administration (FDA) expanded the label for Wegovy (semaglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist, approving the drug for reducing the risk of cardiovascular death, non-fatal heart attack, and non-fatal stroke in adults who are overweight or obese with a history of CVD in the form of a previous heart attack, previous stroke, or symptomatic peripheral artery disease. Wegovy will continue to be available to reduce excess body weight and maintain weight reduction in adults and pediatric patients aged 12 years and older with obesity and adults with overweight in the presence of at least one weight-related comorbidity, and it is anticipated that coverage by insurers for this new indication will be more inclusive over time. Health plans and self-funded employers have been more resistant to covering the cost of “lifestyle drugs,” a category Wegovy and other GLP-1 drugs for obesity fell into in the eyes of many until now. As we delve into the implications of this approval, it's important to understand the nuances and challenges that lie ahead.
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Reasons for the Label Expansion
The FDA’s new approval is based on the cardiovascular outcomes from the SELECT trial. In this trial, those who received Wegovy had a 20% reduction in risk of major adverse cardiovascular events compared to those who received the placebo. Notable is that these patients did not have type 2 diabetes or a glycated hemoglobin level of 6.5% or higher or treatment with any glucose-lowering medication or GLP-1 receptor agonist within the previous 90 days at screening, e.g. the risk reduction was significant even without this comorbidity. Studies are currently examining the role of GLP-1’s in conditions such as heart failure with preserved ejection fraction, metabolic dysfunction-associated steatohepatitis, Alzheimer’s disease, Parkinson’s disease, peripheral artery disease, diabetic kidney disease and cancer, and other pharmaceutical manufacturers are expected to apply for similar GLP-1 label expansions in the future.
Insurance Landscape Changes
With the new indication, insurers will re-evaluate Wegovy and decide if and how coverage for the drug should change. Even Medicare, which is prohibited from covering drugs for weight loss, may reconsider their position. As coverage for GLP-1’s increases, self-funded employers and health plans already grappling with costs associated with GLP-1 medications will face heightened challenges.
A Holistic Approach to CVD Management
GLP-1 medications are not a silver bullet. The FDA has stated that Wegovy should be used in conjunction with lifestyle interventions to be effective. In fact, only 32% of individuals using GLP-1s adhere to the prescribed regimen after one year, underscoring the importance of focusing on interventions alongside pharmacotherapy. To enhance the success of GLP-1 treatment, it is critical to:
- Provide comprehensive medication education and support at initiation
- Incorporate and emphasize the importance of lifestyle interventions to ensure sustainable outcomes
- Monitor medication adherence alongside relevant clinical outcomes, including weight, blood pressure, and cholesterol
The FDA's approval of Wegovy for cardiovascular risk reduction creates new opportunities in the management of obesity and CVD. However, it is important to recognize the complexities and challenges associated with GLP-1 medications. A holistic approach, combining GLP-1s with lifestyle interventions and enhanced medication adherence strategies, will be instrumental in addressing the multifaceted nature of these health concerns. Apps like Hello Heart uses artificial intelligence, behavioral science, and personalized digital coaching to drive lifestyle changes that help users track and manage their heart health with real-time tips. As we navigate this evolving landscape, collaboration between healthcare providers, insurers, and employers becomes paramount in ensuring the success of comprehensive cardiovascular risk reduction strategies.
Hello Heart is not a substitute for professional medical advice, diagnosis, and treatment. You should always consult with your doctor about your individual care.