As Congress considers widening Medicare’s coverage of the burgeoning class of weight loss medications, a new study says further expansion of eligible patients into new indications could cost a pretty penny.
Researchers from Brigham and Women’s Hospital in Boston calculated that expanding the number of eligible Medicare Part D patients who could receive Novo Nordisk’s Wegovy to include those at risk of cardiovascular events could cost as much as $145 billion per year. That’s if the federal program adopted the most liberal criteria — an unlikely scenario — which would include patients with elevated body mass index and either a history of previous cardiovascular events or whose risk of atherosclerotic cardiovascular disease (ASCVD) is greater than or equal to 7.5%.
If Medicare includes the likely eligible population, which would not include patients with an ASCVD risk greater than or equal to 7.5%, then the total maximum annual cost would be roughly $34 billion. The study published Monday was based on survey responses from patients who were 65 or older or who had self-reported Medicare coverage.
Novo won FDA approval in March to expand Wegovy’s use to prevent heart disease after the company’s late-stage SELECT trial found that the drug spurred a 20% reduction in cardiovascular events. Medicare said then that it would cover the drug for patients with both elevated weight and a history of heart disease.
The potential financial burden that Medicare faces as obesity and weight loss medications proliferate has been the center of discussions on Capitol Hill as lawmakers consider legislating a solution. A 2003 law prohibited Medicare Part D from covering drugs used for weight loss, but the Treat and Reduce Obesity Act, introduced by Rep. Brad Wenstrup (R-OH), is looking to change that.
The House Ways and Means Committee advanced a truncated version of the bill back in late June that limited Medicare coverage to newly-enrolled patients who previously had their weight loss medication covered for at least a year prior. An earlier version of the bill had sought to include a wider group of prospective patients. The Congressional Budget Office said in March that at their current cost, widening access to GLP-1 drugs would cost the government more than it would save. Industry stakeholders have argued for wider access by pointing to the potential reduction in more severe (and more costly) diseases if older patients can treat their obesity.
Studying Wegovy in teens
On the other end of the age spectrum, Novo Nordisk is looking to reinforce Wegovy’s use in adolescents with a newly-launched trial.
A posting in the US clinical trials registry outlines a soon-to-start trial testing semaglutide as a weight loss treatment for kids 12 to 15 years old. The trial is set to begin in the middle of September and will test a weekly semaglutide treatment for “a minimum of three years.” Wegovy is already approved for children 12 and older, but the study will look at how many kids report a drop in BMI below the obesity threshold and how many taper off the medication, among other endpoints.
The Phase 4 research study aims to recruit 500 kids and lists dozens of sites across North America and Europe. The primary completion date is more than four years out, slated for mid-November 2028.
A spokesperson for Novo Nordisk did not immediately respond to a request for comment on the trial plans.