A landmark shift in the American medical landscape is underway as millions of Medicare beneficiaries suffering from obesity and heart conditions may soon have access to a highly effective weight-loss drug, according to a recent study. This development is a result of the U.S. Food and Drug Administration’s (FDA) approval of Novo Nordisk’s Wegovy for reducing stroke and heart attack risk in overweight or obese adults without diabetes.
The FDA’s green light potentially paves the way for approximately a quarter of Medicare beneficiaries who are overweight or obese to avail of this weight-loss medication. Notably, Medicare regulations currently prohibit the coverage of drugs solely for weight loss.
The study, published by the Kaiser Family Foundation (KFF), estimates that about 7% of Medicare beneficiaries, or 3.6 million individuals, had documented cardiovascular disease and were obese or overweight in 2020. These individuals could potentially qualify for Wegovy coverage under its new usage indication.
Among the beneficiaries eligible for Wegovy coverage, approximately 1.9 million also suffer from diabetes. These patients may have already been eligible for Medicare coverage of Wegovy and Novo’s widely used diabetes drug, Ozempic.
Wegovy and Ozempic belong to a category of medications known as GLP-1 agonists. Originally developed to treat type 2 diabetes, these drugs have also proven to be highly effective in promoting weight loss.
As Wegovy is a self-administered injectable drug, Medicare coverage would be provided under drug plans managed by private insurers, also known as Part D plans.
The KFF study suggests that while some Part D plans have announced that they will commence Wegovy coverage in 2024, more widespread coverage could be more likely in 2025.
Part D plans may be hesitant to extend coverage due to the high cost of the medication and the significant number of patients eligible for it.
The influence of expanded Wegovy coverage on Medicare spending will depend on several variables. These include the number of Part D plans that add coverage for Wegovy, any restrictions applied by the plans (such as prior authorization), the number of patients that qualify and use the drug, and the prices negotiated by the plans.
The U.S. Centers for Medicare and Medicaid Services (CMS) issued a memo last month indicating that Part D plans can cover Wegovy now that it has an indication that is not excluded from Medicare coverage.
The study also noted that not all Medicare patients eligible to take Wegovy are likely to do so. Factors that could deter usage include out-of-pocket costs—which could range from $325 to $430 monthly before reaching the $2,000 annual cap—and potential side effects of the drug.
The FDA highlighted that Wegovy’s prescribing information comes with a warning about the risk of thyroid C-cell tumors. The drug is not recommended for patients with a personal or family history of medullary thyroid carcinoma or those with a rare condition known as multiple endocrine neoplasia syndrome type 2.
A spokesperson for Novo Nordisk previously stated that the company is continuously reviewing data from ongoing clinical trials and real-world use of its products and collaborating closely with authorities to ensure patient safety and adequate information for healthcare professionals.
