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Medicare will cover the weight-loss drug semaglutide (Wegovy) under its Part D drug program for patients with overweight or obesity who have preexisting heart disease and need the drug to prevent heart attacks or strokes, the Centers for Medicare & Medicaid Services (CMS) said Thursday.

"CMS is committed to ensuring that people have access to treatments and treatment options that improve health outcomes," an agency spokesperson told 乌鸦传媒 in an email. "With the recent change in the FDA approved use for Wegovy (semaglutide), current Medicare Part D and Medicaid coverage rules apply."

The agency told Part D plans, which are run by private insurers, that anti-obesity drugs like semaglutide "that receive FDA approval for an additional medically accepted indication can be considered a Part D drug for that specific use. For example, a drug that receives FDA approval for chronic weight management alone would not be considered a Part D drug. [But] 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 decision to add a drug to a Part D plan formulary can be made any time during the contract year, CMS noted. Other anti-obesity drugs that don't have an additional approved indication cannot be covered by Part D plans "unless provided as a supplemental benefit by the Part D plan," the spokesperson said.

Medicaid plans also will now be required to cover semaglutide for this same group of patients; however, states can still require patients to undergo step therapy with other drugs, or prior authorization, before they can access semaglutide for this indication. (The GLP-1 receptor agonist is already covered by Medicare and Medicaid for type 2 diabetes, which is marketed under the brand name Ozempic for its injectable formulation and Rybelsus for its oral form.)

The FDA announced on March 8 that it had approved the additional indication for semaglutide in adults with cardiovascular disease and either obesity or overweight. The drug should be used in conjunction with a reduced calorie diet and increased physical activity, according to the FDA.

It represented the first weight-loss medication to also gain approval for preventing life-threatening cardiovascular events in this patient population, according to John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity at FDA's Center for Drug Evaluation and Research.

"This patient population has a higher risk of cardiovascular death, heart attack, and stroke," he said in a statement. "Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health."

Underpinning the approval was the 17,600-patient SELECT trial, which included patients with overweight and obesity (with or without diabetes) as well as pre-existing cardiovascular disease. The phase III study showed that semaglutide significantly reduced the composite of cardiovascular death, heart attack, and stroke by 20% (HR 0.80, 95% CI 0.72-0.90). In the 3-year study, where both groups received standard-of-care medical treatment, these major adverse cardiac events occurred in 6.5% of patients on semaglutide and 8% of those on placebo.

FDA noted that the GLP-1 receptor agonist should not be used with other agents in the class, or with other semaglutide-containing products.

Wegovy was first approved in June 2021 for chronic weight management in adults with obesity (BMI of 30 or greater) or for adults with overweight (BMI 27 or greater) with at least one weight-related condition. This indication was later expanded to include children with obesity ages 12 and up.

Consistent with the GLP-1 agonist class, common side effects with semaglutide include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with diabetes, flatulence, and gastroesophageal reflux disease.

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