Millions of Medicare Recipients Could Gain Access to Weight-Loss Drug

Millions of overweight or obese patients with heart conditions insured under Medicare could gain access to a popular weight-loss drug, a study has found.

Novo Nordisk's Wegovy, chemically known as semaglutide, was approved by the U.S. Food and Drug Administration last month for lowering the risk of stroke and heart attack in overweight or obese adults who do not have diabetes.

The FDA's approval of the new use for Wegovy potentially opens up access to the drug for a quarter of people on Medicare who are overweight or obese, according to a study published by the Kaiser Family Foundation (KFF), a nonprofit that researches health policy, on Wednesday. Medicare is prohibited by law from covering Wegovy and other drugs for weight loss alone.

The study found that an estimated 7 percent of Medicare beneficiaries, or 3.6 million overall, had established cardiovascular disease and were obese or overweight in 2020, and they could be eligible for coverage of Wegovy for its new indication. Among those patients, 1.9 million also had diabetes, the KFF study said, and may have been already been eligible for Medicare coverage of Wegovy and Novo's widely used diabetes drug, Ozempic.

Both belong to a class of medications called GLP-1 agonists, which were originally developed to treat type 2 diabetes, but are also highly effective weight-loss drugs.

Because Wegovy is a self-administered injectable drug, Medicare coverage would be provided under drug plans administered by private insurers, known as Part D.

The KFF study said that while some Part D plans have announced they will begin covering Wegovy in 2024, broader coverage in 2025 could be more likely.

Many Part D plans might be reluctant to expand coverage now due to the high price of the drug and the large amount of patients eligible for it "since they can't adjust their premiums mid-year to account for higher costs associated with use of this drug," the study said.

How the expanded coverage of Wegovy will impact Medicare spending will also depend on how many Part D plans add coverage for it and the extent to which the plans apply restrictions like prior authorization, how many people who qualify to take the drug use it and the negotiated prices paid by plans, the study said.

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.

"CMS has issued guidance to Medicare Part D plans stating that anti-obesity medications (AOMs) that receive FDA approval for an additional medically accepted indication can be considered a Part D drug for that specific use," a spokesperson for the federal agency told Newsweek last month. "Part D coverage is still not available for AOMs when used for chronic weight management in patients who do not have the additional medically accepted indication, unless provided as a supplemental benefit by the Part D plan."

The agency has been contacted for further comment via email.

The study also noted that not all Medicare patients eligible to take Wegovy are likely to take it, as some could be put off by the out-of-pocket costs—which could be between $325 and $430 monthly, before reaching the $2,000 annual cap—and the potential side effects of the drug.

"There are a number of reasons someone may not want to take Wegovy," Tricia Neuman, a senior vice president and a Medicare policy specialist at KFF, told Newsweek via email.

"Even with Medicare coverage, out-of-pocket costs could be a big barrier, especially for older people with modest incomes. Some might also be worried about potential side effects or hesitant to take the drug in perpetuity to avoid gaining back the weight."

The FDA said the prescribing information for Wegovy contains a warning to health about the risk of thyroid C-cell tumors and that the drug should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called multiple endocrine neoplasia syndrome type 2.

The drug also contains warnings for inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, hypersensitivity reactions, diabetic retinopathy (damage to the retina), increased heart rate and suicidal behavior or thinking.

A spokesperson for Novo Nordisk previously told Newsweek that the company "is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals."

Update 4/24/24 at 10:50 a.m. ET: This article has been updated to add comment from Tricia Neuman.