Medicare Semaglutide Coverage: Millions May Gain Access That Could Cost $145 Billion

Approximately 61% of Medicare-eligible adults had a BMI of 27 or more, making them potentially eligible for semaglutide.

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According to a study published today in Annals of Internal Medicine, expanding Medicare coverage for semaglutide could make millions of older Americans newly eligible for the drug, but with the potential to add up to $145 billion annually to federal health care costs; the decision hinges on how broadly "cardiovascular disease" is defined.¹

Evolving discussions have been happening with the potential expansion of Medicare coverage for semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. Traditionally prescribed for diabetes and weight loss, semaglutide has recently gained attention for its cardiovascular benefits, the authors noted. In March 2024, Medicare announced that Part D plans could cover semaglutide (Wegovy; Novo Nordisk) for patients with elevated body mass index ([BMI]; BMI ≥ 27 kg/m²) and established cardiovascular disease (CVD), regardless of their diabetes status. This decision followed the SELECT trial, demonstrating that semaglutide significantly reduces cardiovascular events in certain patients without diabetes.

More specifically, the SELECT trial revealed that the weight loss drug significantly reduces the risk of major adverse cardiac events (MACE) and heart failure in patients who are overweight or obese with atherosclerotic cardiovascular disease, regardless of heart failure presence or type.² Among over 17,600 participants, semaglutide led to a 28% lower risk of MACE in patients with heart failure and substantial reductions in cardiovascular death and all-cause mortality. The benefits were consistent across different patient factors, positioning semaglutide as a promising treatment option for this high-risk population.

However, Medicare has not clearly defined what constitutes "established CVD," leading to variability in potential patient eligibility; therefore, the new research aimed to estimate the number of Medicare beneficiaries who would become newly eligible for semaglutide under different definitions of established CVD.¹ Additionally, it sought to assess the maximum financial impact on Medicare Part D should these beneficiaries receive coverage for the drug.

Researchers analyzed data from the National Health and Nutrition Examination Survey (NHANES) collected between 2011 and 2020. It included respondents aged 65 and older or those enrolled in Medicare. Interview responses, medication use, clinical examinations, laboratory data, and diabetes diagnoses (patients taking antidiabetic medication or those with glycosylated hemoglobin ≥ 6.5%) were included in the data collected.

Potential Definitions of Established CVD Evaluated:

1. Self-reported diagnosis of myocardial infarction, stroke, coronary artery disease, or angina, closely aligned with the SELECT trial criteria.
2. 10-year atherosclerotic CVD (ASCVD) risk of 7.5% to 19.9%.
3. 10-year ASCVD risk of 20% or more.
4. Any of the above 3 criteria.

The study also compared the sociodemographic characteristics of Medicare beneficiaries who might be newly eligible for semaglutide under these definitions against those previously eligible. Maximum Medicare spending was estimated by multiplying the number of newly eligible beneficiaries by the annual net price of semaglutide, accounting for an average 41% discount from the manufacturer list price in March 2024.

Of 5111 respondents, approximately 61% of Medicare-eligible adults had a BMI of 27 or more, making them potentially eligible for semaglutide. Weighted estimates suggested that 3.6 million people (14.2%) were highly likely to be newly eligible under the most restrictive definition of established CVD. However, more liberal definitions could increase this number to 15.2 million people (60.9%).

The analysis indicated that if all newly eligible beneficiaries received semaglutide, the maximum additional spending by Medicare could range from $34 billion to $145 billion annually. The demographic analysis revealed that the eligibility of Medicare beneficiaries would vary significantly depending on the definition of established CVD, with younger, healthier, and female beneficiaries likely remaining ineligible under more restrictive criteria.

The researchers noted that a narrower definition would limit access to about 1 in 7 Medicare beneficiaries with an elevated BMI, while broader criteria could dramatically expand eligibility. Given the public health benefits of weight control for patients with elevated BMI, the chosen definition could have significant implications.

"Weight control has benefits for patients with elevated BMI, so the definition of established CVD used by Part D plans for coverage of semaglutide could have outsized public health implications," the researchers stated. "Nonetheless, access to semaglutide will also be impacted by patient out-of-pocket costs, formulary placement, drug shortages, and utilization management strategies. For example, if semaglutide is placed on the specialty tier, Part D plans could charge 25% to 33% of the retail drug cost."

Even with a restrictive definition of CVD and low persistent use rates around 30%, as seen among commercially insured users without diabetes, semaglutide could still add more than $10 billion in annual federal spending, making it one of the costliest drugs under Medicare Part D—highlighting the urgent need for policy solutions to manage the budgetary impact as access to semaglutide expands.

Limitations of the analysis were acknowledged, including reliance on self-reported data and the exclusion of Medicare beneficiaries residing in long-term care facilities, who comprise approximately 2% of the population. The study also focuses on maximum budgetary impact rather than a precise spending projection and does not account for potential payment reforms under the Inflation Reduction Act. Additionally, it does not consider contraindications to semaglutide or the possibility of patients with diabetes switching from Ozempic to Wegovy.

References

1. Chaitoff A, Bendicksen L, Feldman WB, Zheutlin AR, Lalani HS. Estimating new eligibility and maximum costs of expanded Medicare coverage of semaglutide for cardiovascular risk prevention. Annals of Internal Medicine. August 26, 2024. doi:10.7326/ANNALS-24-00308

2. Klein H. Patients with heart failure may benefit from weight loss drug. AJMC. August 24, 2024. Accessed August 26, 2024. https://www.ajmc.com/view/patients-with-heart-failure-may-benefit-from-weight-loss-drug