In a significant development, Medicare may extend coverage for Novo Nordisk A/S’s NVO weight-loss drug Wegovy (semaglutide) to certain members with a history of heart disease.
The Centers for Medicare and Medicaid Services (CMS) revealed that Medicare Part D drug-benefit plans, overseen by private insurers, could potentially cover anti-obesity medications under specific circumstances.
Earlier this month, the FDA approved Wegovy for expanded use in obesity and cardiovascular disease management.
In August 2023, Novo Nordisk released the headline results from the SELECT cardiovascular outcomes trial, better than the 15-17% expected by investors and analysts.
The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 20% for people treated with semaglutide 2.4 mg compared to placebo.
The eligibility criteria further stipulate a body-mass index above a certain threshold.
Novo Nordisk released the headline results from the FLOW kidney outcomes trial earlier this month.
The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in kidney disease progression and cardiovascular and kidney death of 24% for people treated with semaglutide 1.0 mg compared to placebo.
Wall Street Journal noted the agency’s guidance maintains coverage for drugs like Ozempic and Mounjaro, which contain similar ingredients to Wegovy and Zepbound but are approved for treating Type 2 diabetes rather than weight loss.
Many Part D plans already cover these diabetes drugs. CMS permits Part D plans to implement prior authorization for anti-obesity medications to ensure compliance with federal regulations regarding their medically accepted use.
Also, Germany’s health ministry refuted claims made by the head of the drugs regulator, BfArM, suggesting a potential ban on exporting large volumes of Novo Nordisk’s diabetes drug Ozempic, with semaglutide as a key ingredient.
Despite efforts to alleviate the scarcity, the launch of Wegovy in Germany and the introduction of a competitor, Mounjaro, by Eli Lilly And Co LLY, have not diminished the demand for Ozempic, Reuters noted.
The situation has prompted discussions within BfArM about potential interventions, including an export ban if other strategies like regulating off-label use prove ineffective.
The agency has been grappling with Ozempic shortages for about a year, acknowledging the unpredictability of availability.
Price Action: NVO shares are up 0.51% at $131.03 on the last check Thursday.
Image Via Shutterstock
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
