The FDA Has Announced a New Cardiovascular Indication for Wegovy®
On March 8, 2024, the Food and Drug Administration (FDA) approved a new indication for the use of Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and are obese or overweight. Wegovy should be used in addition to a reduced calorie diet and increased physical activity.
Wegovy was approved based on the data from the SELECT trial. The clinical trial enrolled 17,604 patients and examined whether Wegovy (semaglutide) can reduce cardiovascular risks associated with overweight and obese patients who are not diabetic.
Below are the inclusion criteria and baseline characteristics for the participants in the SELECT trial:
- BMI: ≥27
- Age: ≥45
- No history of diabetes
- With established cardiovascular disease (secondary prevention):
- Previous myocardial infarction
- Previous ischemic or hemorrhagic stroke OR
- Symptomatic peripheral arterial disease as evidenced by intermittent claudication with ankle
Starting Wegovy on elderly patients should be approached with caution. The SELECT trial data, with only 38% of participants aged 65 or older, suggests that its efficacy and safety in the Medicare population might not be fully understood. Elderly patients often have a higher risk of experiencing serious complications from muscle wasting. Therefore, before prescribing Wegovy for elderly patients, the potential benefits against the heightened risks should be thoroughly assessed.
Wegovy was previously excluded from Part D benefits due to Centers for Medicare and Medicaid Services (CMS) regulations of weight loss medications. Due to recent changes, CMS will now allow anti-obesity medications to be covered if there are other indications besides weight loss. Premera is currently evaluating the coverage criteria of Wegovy to ensure alignment with CMS guidance.