New FDA Approval Opens Door for Medicare Coverage of Wegovy for Certain Senior Citizens and Beneficiaries with Heart Disease
The US Food and Drug Administration (FDA) has approved an application from Danish pharmaceutical company Novo Nordisk to expand the label of their medication Wegovy to include cardiovascular benefits. This approval paves the way for Medicare coverage for certain senior citizens and other beneficiaries with a history of heart disease who require this medication.
The Centers for Medicare and Medicaid Services (CMS) has informed insurers that provide Medicare Part D drug plans of this development. According to CMS, if an anti-obesity medication (AOM) receives FDA approval for an additional medically accepted indication, it can be considered a Part D drug for that specific use. This means that Wegovy may now be covered under Medicare Part D plans for individuals with established heart disease who need it to help manage their weight and reduce the risk of major adverse cardiovascular events.
Wegovy is one of four GLP-1 receptor agonists, which have gained immense popularity in recent years due to their efficacy in weight loss. Two of these medications, Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, are primarily used to treat diabetes patients. However, Wegovy and Eli Lilly’s Zepbound were approved only as anti-obesity drugs, making their coverage less likely in commercial insurance plans. This approval expansion could potentially change that.
CMS also announced that states would be required to cover Wegovy in their Medicaid plans to prevent cardiovascular disease in people with obesity. However, states may also take steps to control usage, such as requiring patients to try other medications or treatments first.
Despite discounts provided by drugmakers, the high list prices of these medications make them unaffordable for many Americans. Wegovy costs $1,349 for a four-week supply, while Zepbound is priced at $1,060. The list prices for Ozempic and Mounjaro are $969 and $1,069 per four weeks, respectively.
The FDA’s approval was based on a 17,000-patient study that demonstrated people taking Wegovy had a 20% lower risk of cardiac events compared to those on placebo. Dr. John Sharretts, director of the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, stated in a news release that “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.”
Although the coverage of Wegovy and similar drugs could potentially reduce healthcare spending, these medications at their current prices would likely still cost the federal government more than they would save. Some of the costs would be borne by Medicare enrollees through higher premiums and out-of-pocket costs.
