Five

Ahmed Abrenun

WASHINGTON (Reuters) – Heart disease patients insured by the U.S. Medicare program will be covered for Novo Nordisk’s weight loss drug Wegoby as long as it is prescribed to reduce the risk of heart attack or stroke. The agency overseeing the program announced Thursday.

Medicare prescription drug plans run by private insurance companies (known as Part D) currently cannot cover obesity drugs. But under new guidance, Medicare will pay for such drugs once they receive U.S. approval for covered secondary uses, according to the U.S. Centers for Medicare and Medicaid Services (CMS). That’s what it means.

Based on positive results in 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 without diabetes.

“CMS provides for Medicare Part D plans that anti-obesity drugs that receive FDA approval for additional medically recognized indications can be considered Part D drugs for that specific use. We have issued guidance,” a CMS spokesperson said in an emailed statement.

Analysts predict that the weight-loss drug market could reach at least $100 billion a year by the end of 2010, as production of Wegoby and Eli Lilly’s Zepbound and Munjaro cannot keep up with staggering demand. There is.

Wegoby’s reporting from Medicare makes the drug subject to government price negotiations under President Joe Biden’s Inflation Control Act. CMS said the prices it negotiates apply to drugs that share the same active ingredients, not specific brands.

Novo Nordisk told analysts last year that it had negotiated the price Medicare would pay for its diabetes drug Ozempic, which contains the same active ingredient semaglutide as Wigovy, and said it expected to announce a new price for the drug in 2027. By negotiation.

Medicare is prohibited under the Social Security Act from covering certain drugs, including those used to treat anorexia, weight loss, and weight gain. CMS said in its guidance that the use of weight loss drugs solely for the purpose of treating obesity remains not covered.

A CMS spokesperson said, “Drugs that are FDA-approved solely for chronic weight management are not considered Part D drugs.” “If this same drug was also approved by the FDA to treat diabetes and reduce the risk of serious adverse cardiovascular events in obese or overweight adults with established cardiovascular disease, It would be considered a Part D drug for intended use only,” the spokesperson said.

Approximately 65 million people enroll in Medicare, the U.S. government’s health insurance program for people age 65 and older or with disabilities.

A CMS spokesperson added that state Medicaid programs for low-income people and their families would be required to use Wegovy to prevent heart disease in obese people.

(Reporting by Ahmed Aboulenein; Additional reporting by Patrick Wingrove in New York; Editing by Bill Berkrot)