2024-03-21 20:23:14
Heart patients insured by the U.S. Medicare program will be covered by Wegovy, Novo Nordisk’s weight-loss drug, provided it is prescribed to reduce their risk of heart attacks and strokes, the agency that oversees said Thursday the program.
Drug plans administered by private insurers, known as “Part D,” currently cannot cover obesity medications. However, under the new guidelines, these drugs will be reimbursed if approved by the United States for secondary use covered by Medicare, the US Centers for Medicare and Medicaid Services (CMS) said.
Based on positive results from a large clinical trial, the FDA approved Wegovy earlier this month to reduce the risk of stroke and heart attack in overweight or obese adults who do not have diabetes.
“CMS has issued guidance to Medicare Part D plans indicating that anti-obesity drugs that receive FDA approval for an accepted additional medical indication may be considered a Part D drug for that specific use” , a CMS spokesperson said in an emailed statement.
Analysts have forecast that the market for weight-loss drugs could reach at least $100 billion a year by the end of the decade, with production from Wegovy and Eli Lilly’s Zepbound and Mounjaro not able to meet growing demand.
A Novo spokesperson said the company is encouraged by the guidance, but that additional efforts are needed because Medicare still does not cover obesity medications intended for chronic weight management.
Medicare’s takeover of Wegovy paves the way for price negotiations with the government under President Joe Biden’s Inflation Reduction Act. CMS said negotiated prices would apply to drugs that share the same active ingredient rather than specific brands.
Last year, Novo Nordisk told analysts that it expected Medicare to negotiate the price it will pay for the diabetes drug Ozempic, which contains the same active ingredient as Wegovy, semaglutide, and issue new drug prices in 2027. She added that she expected Wegovy to be affected by the negotiations.
The Social Security Act prohibits Medicare from covering certain medications, including those used to treat anorexia, weight loss, and weight gain. CMS indicated in its guidelines that weight loss medications still cannot be supported when used solely to treat obesity.
“A drug that receives FDA approval for chronic weight management would not be considered a Part D drug,” the CMS spokesperson said. “If this same drug is also approved by the FDA to treat diabetes or reduce the risk of major cardiovascular events in adults with established cardiovascular disease and obesity or overweight, then it would be considered a drug of Part D for these specific uses only,” the spokesperson said.
About 65 million people are enrolled in Medicare, the U.S. government’s health insurance program for people age 65 and older or people with disabilities.
State Medicaid programs for low-income individuals and families would be required to cover Wegovy when it is used to prevent heart disease in people with obesity, the CMS spokesperson added.
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