The Centers for Medicare and Medicaid Services said it has informed insurers that provide Medicare Part D drug plans that they could cover the medication after the FDA expanded the approval this month.
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"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," CMS said in a statement.
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Medicare is not allowed by law to cover drugs for chronic weight management, although Congress is facing pressure to change that. But if the same medication also receives FDA approval to reduce the risk of heart attacks, strokes and other major adverse cardiovascular events, it could be added to Part D formularies for people with established heart disease, the agency said.
Insurers may use prior authorization - or advance approval - to ensure that Wegovy is being used for a medically accepted indication, CMS said. The FDA approval applies to adults with cardiovascular disease and who are either obese or overweight.
The Wall Street Journal first reported the CMS guidance.
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Wegovy is one of four wildly popular - and super expensive - medications called GLP-1 receptor agonists. Two of them, Novo Nordisk's Ozempic and Eli Lilly's Mounjaro, are approved to treat people with diabetes. They are more likely to be covered by Medicare Part D plans and by commercial insurers for diabetes patients.
But Wegovy and Eli Lilly's Zepbound were approved only as anti-obesity drugs, until the FDA's recent expanded approval for Wegovy. So they are much less likely to be covered by insurers in commercial plans and were covered by only a few state Medicaid programs.
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CMS also said that states would be required to cover Wegovy in their Medicaid plans to prevent cardiovascular disease in people with obesity but could also take steps to control usage, such as requiring patients to try other medications or treatments first.
Though the drugmakers provide some discounts for all four medications, their high list prices put them out of reach for many Americans. Wegovy costs $1,349 for a four-week supply, while Zepound is priced at $1,060. The list price for Ozempic is $969 for a four-week supply, and Mounjaro costs $1,069.
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The FDA approval was based on a 17,000-patient study that showed that people taking Wegovy had a 20% lower risk of a cardiac event than those taking a placebo.
"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," Dr. John Sharretts, director of the FDA's Division of Diabetes, Lipid Disorders, and Obesity, said in a news release.
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Although coverage of Wegovy and similar drugs could reduce other health care spending, these medications at their current prices would probably still cost the federal government more than they would save, according to a Congressional Budget Office analysis released Wednesday. Some of the cost would be borne by Medicare enrollees through higher premiums and out-of-pocket costs.
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