Semaglutide May Become Medicare Part D’s Most Expensive Drug

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Only 14% of the 3.6 million Medicare beneficiaries with high body mass index and established cardiovascular disease may qualify for semaglutide approval, according to the results of a new study from researchers at Brigham and Women’s Hospital at Harvard Medical School. If this happens, Medicare spending could be an additional $34 to $145 billion annually, the study shows. Results were published today at the Annals of Internal Medicine.

In March 2024, Medicare announced it would allow Part D plans to cover semaglutide for individuals with a BMI of 27 or higher with cardiovascular disease, regardless of whether they have diabetes. This is because of the results of the SELECT trial, where semaglutide was associated with a 20% reduction in cardiovascular symptoms in obese individuals. However, Medicare only defines established cardiovascular disease as having had a heart attack, stroke or peripheral artery disease, which leaves lingering questions about coverage.

“When established cardiovascular disease is narrowly defined, only 1 in 7 Medicare beneficiaries with elevated BMI are likely to be eligible to receive semaglutide, but costs to Medicare could still exceed $10 billion per year,” lead author Alexander Chaitoff, M.D., MPH, from the Center for Healthcare Delivery Sciences in the Division of Pharmacoepidemiology at BWH said in a news release published today. “In this conservative coverage scenario, that means most beneficiaries with elevated BMI and cardiovascular risk would remain ineligible for semaglutide, yet the medication could still potentially become one of the costliest drugs to Medicare.”

To identify which beneficiaries would potentially be covered, researchers analyzed data from the National Health and Nutrition Examination Survey from 2011 to 2020, focusing on patients 65 and older or those with self-reported Medicare enrollment.

A broader definition of cardiovascular disease was defined using the following criteria:

1). A self-reported, physician diagnosed report of heart attack, stroke, coronary artery disease or chest pain.

2). 10-year atherosclerotic risk of 7.5% or more, but less than 20%.

3). 10-year atherosclerotic risk of 20% or more.

The maximum potential cost was found by calculating the annual net price of semaglutide and multiplying it by the number of newly eligible beneficiaries.

Access to semaglutide will also be impacted by patient out-of-pocket cost, formulary placement and drug shortages, the study reads.

“For example, if semaglutide is placed on the specialty tier, Part D plans could charge 25% to 33% of the retail drug cost,” Chaitoff writes in the study. “Thus, near-term policy solutions are needed to control budgetary impacts as semaglutide access expands.”