The number of patients who will be eligible for Novo Nordisk’s blockbuster GLP-1 under new Medicare Part D plan guidelines will vary depending on how cardiovascular disease is defined, according to researchers.
Providing Part D Medicare coverage for Novo Nordisk’s semaglutide to reduce cardiovascular disease risk in certain patients could cost the U.S. government up to $145 billion annually, according to new research published Tuesday in the Annals of Internal Medicine.
Branded as Ozempic for type 2 diabetes and Wegovy for chronic weight management, semaglutide is a blockbuster GLP-1 receptor agonist that promotes insulin secretion from the pancreas and helps suppress appetite. The Centers for Medicare and Medicaid Services (CMS) covers the therapy for diabetes but has so far not approved its coverage for anti-obesity use.
However, in November 2023, Novo Nordisk unveiled data from the Phase III SELECT study which showed that a 2.4-mg Wegovy dose could significantly reduce the risk of major adverse cardiovascular events by 20% versus placebo. Patients treated with Wegovy also saw a 28% lower risk of heart attack or myocardial infarction.
The findings led the FDA to expand Wegovy’s approval in March 2024, allowing its use to decrease the likelihood of cardiovascular death, heart attack and stroke in overweight and obese adults with cardiovascular disease (CVD). Soon after, CMS announced that it would cover Wegovy for this use, and specifically for patients with body mass index of at least 27 kg/m2. The agency has yet to release its detailed definition of CVD.
In Tuesday’s study, researchers from the Department of Medicine at the Brigham and Women’s Hospital in Boston looked at how many patients would be affected by this change in coverage and its potential impact on Medicare.
Using 2011-2020 data from the National Health and Nutrition Examination Surveys, the researchers found that around 3.6 million adults would be eligible for semaglutide coverage under CMS’ new guidelines. When applying more liberal definitions of CVD, this coverage population could further balloon to 15.2 million adults, according to the study.
If all of these new beneficiaries used semaglutide, annual Medicare expenditure could jump by $34 billion to $145 billion, the researchers found.
Their analysis follows a March 2024 report from the Congressional Budget Office (CBO) which found that at its current cost—ranging from $1,000 to $1,300 for a four-week supply—Medicare will not be able to sustainably cover semaglutide.
At the time, the CBO’s analysts wrote that anti-obesity medications such as semaglutide “would cost the federal government more than it would save from reducing other healthcare spending,” leading to an “overall increase in the deficit over the next 10 years.” Due to the medication’s price and medical value, the CBO also predicted that semaglutide would most likely be selected for Medicare drug price negotiations “within the next few years.”
Wall Street analysts are predicting that Ozempic will be on CMS’ list of 2027 Medicare drug price negotiations, according to reporting last week from Reuters.
