The weight loss drug Wegovy has recently been given a supplemental cardiovascular indication by the FDA, allowing limited access to certain Medicare beneficiaries who meet specific weight and major cardiovascular risk criteria. While Medicare currently does not cover medications for obesity, this new indication may open the door for coverage by health plans operating in the Medicare Part D program. However, restrictions on coverage may still be put in place, such as requiring patients to try cheaper alternatives first before being able to access Wegovy.
State Medicaid agencies will now be required to include Wegovy on their list of reimbursable drugs, but they can still impose step edits that may require patients to try other options before being able to obtain Wegovy for the cardiovascular indication. Since Wegovy does not fall under one of the six protected drug classes in Medicare, plans do not have to include it on their formulary, making it likely that coverage decisions will be cautious. Additionally, the limited number of beneficiaries eligible for coverage presents another challenge, as the FDA’s decision to add the cardiovascular indication to Wegovy was based on data from a trial involving a very specific population at severe risk for major cardiovascular events.
Despite the modest reduction in cardiovascular events seen in the clinical trial participants taking Wegovy, with an absolute risk reduction of 1.5%, insurers may view the cost-effectiveness of the drug as questionable. There is also concern about patient adherence to obesity medications, as studies have shown that only 40% of patients were persistent with semaglutide-based products after one year, with real-world data showing even lower persistence rates. This may lead insurers to question the long-term effectiveness and cost savings associated with covering Wegovy for at-risk Medicare beneficiaries.
While the addition of a cardiovascular indication to Wegovy may provide access to the drug for certain Medicare beneficiaries, it is expected that coverage by Medicare plans will come with stringent restrictions. Insurers may implement prior authorization protocols and other utilization management tools to ensure that the drug is only used by patients who truly need it. The relatively small reduction in cardiovascular events, coupled with concerns about patient adherence, may lead insurers to closely evaluate the value proposition of covering Wegovy for this specific sub-population at severe risk for major cardiovascular events.
