Medicare will now provide coverage for the weight-loss drug Wegovy for patients at risk of heart attacks and strokes, the U.S. Centers for Medicare and Medicaid Services (CMS) said on Thursday.
This comes after the U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s Wegovy for use to reduce the risks of life-threatening cardiovascular events in overweight or obese adults.
“CMS has issued guidance to Medicare Part D plans stating that anti-obesity medications that receive FDA approval for an additional medically accepted indication can be considered a Part D drug for that specific use,” a CMS spokesperson stated.
Presently, Medicare prescription drug plans administered by private insurers, known as Part D, do not cover obesity drugs. The CMS said its new guidance will cover such drugs if they receive U.S. approval for a secondary use that Medicare already covers.
However, it stated that FDA-approved drugs intended for treating obesity alone would not be considered as Part D drugs. Medicare is barred from covering weight loss drugs under the Social Security Act.
“If this same drug also receives FDA approval to treat diabetes or reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, then it would be considered a Part D drug for those specific uses only,” the spokesperson said.
The FDA’s approval was based on a double-blinded trial with over 17,600 participants, which found that Wegovy significantly reduced the risk of cardiovascular events by 20 percent compared to placebo.
The trial was a large, double-blind, placebo-controlled study designed to assess the cardiovascular benefits of the drug in overweight and obese patients with preexisting heart disease but not diabetes.
Its findings showed that risk reductions in cardiovascular events were achieved over five years regardless of baseline age, sex, race, ethnicity, body mass index, and level of renal function impairment.
The WHO stated that more than four out of five cardiovascular-related deaths are due to heart attacks and strokes, and one-third of these deaths occur prematurely in people under the age of 70.