Changes in Semaglutide Fills Following Expanded FDA and Medicare Policies

ABSTRACT

Objectives: The glucagon-like peptide-1 receptor agonist (GLP-1 RA) semaglutide has several branded versions, including Wegovy, which was initially approved for chronic weight management. In March 2024, the FDA expanded Wegovy’s indications to include reducing cardiovascular events in patients with overweight or obesity and cardiovascular disease. That same month, Medicare Part D expanded coverage for this indication. Evidence is lacking on how these policy changes have affected the utilization of Wegovy and other semaglutide products.

Study Design: Retrospective analysis of monthly semaglutide fills in the US before and after expanded FDA indications and Medicare coverage.

Methods: IQVIA National Prescription Audit PayerTrak data were used to assess temporal trends in semaglutide utilization by brand and payer between September 2023 and September 2024. Additionally, linear segmented regression was used to identify the number of additional fills associated with the FDA and Medicare policy changes.

Results: Total semaglutide utilization increased during the study period, with Wegovy showing the largest relative increase compared with the prepolicy period (136.4%) among all semaglutide products. The greatest increase in relative utilization by payer was for Wegovy purchased through Medicare Part D (598.1%). Policy implementation was associated with an estimated 592,624 additional Wegovy fills by September 2024.

Conclusions: Expanded FDA indications and Medicare coverage of semaglutide for cardiovascular risk prevention were associated with increased Wegovy utilization, most notably through Medicare Part D. These policies may serve as a template for improving access to semaglutide and other GLP-1 RAs as the clinical indications for these drugs continue to expand.

Am J Manag Care. 2026;32(7):In Press

Takeaway Points

We examined monthly semaglutide fills in the US before and after the expansion of FDA indications and Medicare coverage for cardiovascular risk prevention in patients with overweight or obesity and cardiovascular disease. We found that total semaglutide utilization increased throughout the study period, with the following notable findings:

• Wegovy fills increased 136.4% compared with the prepolicy period.
• Medicare Part D fills for Wegovy increased 598.1% compared with the prepolicy period.
• Policy implementation was associated with 592,624 additional Wegovy fills by September 2024.
• Future research should examine the extent to which Medicare Part D drug plans, including Medicare Advantage, have expanded their formularies to ensure affordable coverage for Wegovy.

More than 70% of US adults have overweight or obesity, conditions that are associated with increased risk of morbidity, including from cardiovascular disease (CVD).¹ Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have emerged as a class of medications with significant weight loss benefits in patients with overweight or obesity.² Among GLP-1 RAs, semaglutide is one of the most effective drugs and can lead to average weight loss of up to 15%.³ Although all semaglutide products have weight-loss benefits, Wegovy is the only one specifically approved for chronic weight management in adults without diabetes.⁴ In March 2024, the FDA approved a new indication for Wegovy to reduce cardiovascular risk in adults with overweight or obesity and CVD based on new clinical trial evidence.^5,6 As a result, Medicare Part D plans—previously prohibited from covering medications indicated solely for weight loss—were permitted to cover Wegovy, potentially expanding access to 1 in 4 Part D beneficiaries with overweight or obesity.⁷ This study measures changes in fills of Wegovy and other semaglutide products after these policies expanded coverage for and access to Wegovy.

METHODS

We analyzed monthly semaglutide prescription fills from September 2023 through September 2024 using IQVIA’s National Prescription Audit PayerTrak, which captures data from 92% of retail pharmacies and 70% of mail-order and long-term care facility pharmacies. Fills were analyzed by brand (Wegovy, Ozempic, Rybelsus) and payer type (cash, commercial insurance, Medicaid, Medicare Part D). Segmented linear regression analysis was used to identify the number of additional fills associated with the expanded FDA indications and Medicare coverage in March 2024, beyond what would have occurred as a continuation of prior trends; this model adjusted for calendar year and compared data from 6 months before and after these policy changes (September 2023 to February 2024 and April to September 2024, respectively). March 2024 was excluded due to midmonth policy implementation. Predicted fills for September 2024 were estimated with and without the policy changes. Statistical analyses were performed in Stata 17.0 (StataCorp LLC), with robust SEs and 2-sided P values less than .05 considered significant. This study was exempted and informed consent was waived because it was not considered human participants research by the University of Southern California Institutional Review Board.

RESULTS

Total semaglutide fills increased throughout the study period (2,381,016 in September 2023 to 3,341,613 in September 2024), primarily driven by growth in Wegovy and Ozempic fills (Figure [A]). Relative to February 2024, the last prepolicy month, the largest increase in fills occurred for Wegovy, rising by 136.4% (367,371 in February 2024 to 868,301 in September 2024). During the same period, Ozempic fills increased 26.3% (1,781,484 to 2,250,443), and Rybelsus fills increased 4.8% (212,746 to 222,868) (Figure [B]). When we evaluated fills specifically purchased through Medicare Part D, there was an absolute increase in Wegovy and Ozempic fills over time (Figure [C]), with the greatest relative increase observed for Wegovy (Figure [D]). Assessing Wegovy fills by payer type revealed increases across all payers except cash (Figure [E]), with Part D fills showing the largest relative increase (598.1%; 4,689 fills in February 2024 to 32,732 fills in September 2024) (Figure [F]).

When calculating the number of additional fills associated with the policy change, beyond expected levels based on prior trends, Wegovy experienced a significant increase, whereas Ozempic and Rybelsus did not (Table). Compared with expected values based on prior trends, Wegovy fills increased by an additional 592,624 (95% CI, 464,446-720,803; P < .001) fills by September 2024. Wegovy fills also significantly increased for all payer types following the policy changes (Table). Relative to February 2024, the greatest percentage increase in predicted fills was observed for Wegovy fills purchased through Medicare Part D (640.8%), followed by Medicaid (239.9%), commercial insurance (137.6%), and cash (49.7%).

DISCUSSION

This analysis reveals a significant increase in total and Medicare Part D prescriptions for Wegovy after the FDA added a new indication for adults with overweight or obesity and CVD and Medicare Part D started to cover Wegovy in accordance with this indication. There was no comparable increase in other semaglutide products unaffected by the policy changes. Furthermore, Wegovy fills increased across all insurance types following the policy changes, with the greatest relative increase observed for fills purchased through Medicare Part D. These results suggest that removing coverage restrictions plays a critical role in improving access to semaglutide.

This finding is particularly important given evidence of the therapeutic benefit of GLP-1 RAs across an expanding list of chronic conditions, including obstructive sleep apnea, knee osteoarthritis, chronic kidney disease, and metabolic dysfunction–associated steatohepatitis.^8-11 As these high-cost medications become increasingly more common in the management of chronic diseases associated with overweight and obesity, ensuring access to semaglutide and other GLP-1 RAs will be important.

Despite increased Medicare Part D fills for Wegovy, utilization among eligible beneficiaries remains low. Six months after Part D plans began covering Wegovy (September 2024), only 32,732 prescriptions were filled, representing less than 1% of the estimated 3.6 million eligible beneficiaries.⁷ Potential explanations include exclusion of Wegovy from both stand-alone prescription plans for traditional Medicare and Medicare Advantage drug plans,¹² high co-payments or coinsurance,¹³ and limited provider awareness of the new policies.

Limitations

Study limitations include a lack of individual-level data, such as prescribing indications and co-payment amounts. Future research should investigate the extent to which Medicare Part D plans under both traditional Medicare and Medicare Advantage have expanded their formularies to include Wegovy, and how differences in prescribing and cost sharing influence uptake.

CONCLUSIONS

Wegovy utilization increased after the expanded FDA indications and Medicare coverage for cardiovascular risk prevention in adults with overweight or obesity and CVD. Given the prior Medicare prohibition on coverage for drugs used solely for chronic weight management, these new federal policies may act as a template for increasing access to semaglutide and other GLP-1 RAs as the number of clinical indications for these drugs continues to grow.

Author Affiliations: Schaeffer Center for Health Policy & Economics (CS, JAR, RM, DG, DMQ), Sol Price School of Public Policy (JAR, DG), and Program on Medicines and Public Health, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences (JAR, DMQ), University of Southern California, Los Angeles, CA; Department of Population Health Sciences, University of Wisconsin (RM), Madison, WI.

Source of Funding: There was no direct funding for this project. Dr Myerson is supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (grant 1R01DK141885-01).

Author Disclosures: Dr Goldman reports receiving grants from Alexion, American Heart Association, Amgen, BioMarin, Blue Cross Blue Shield of Arizona, Blue Cross Blue Shield of Massachusetts, BrightFocus, Bristol Myers Squibb, California Hospital Association, Cedars-Sinai Health System, Charles Koch Foundation, CommonSpirit Health, Edwards Lifesciences, Gates Ventures, Genentech, Gilead Sciences, Incyte, Johnson & Johnson, Lilly, National Institute on Aging, National Institute of Diabetes and Digestive and Kidney Diseases, Novartis, Pfizer, RA Capital, and Roche; receiving personal fees from Edwards Lifesciences and GRAIL; and being cofounder of EntityRisk and receiving equity for this role. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (CS, JAR, DMQ); acquisition of data (DMQ); analysis and interpretation of data (CS, JAR, RM, DMQ); drafting of the manuscript (CS, JAR, RM, DG, DMQ); critical revision of the manuscript for important intellectual content (CS, JAR, RM, DG, DMQ); statistical analysis (CS); obtaining funding (DMQ, DG); and supervision (DMQ).

Address Correspondence to: Dima Mazen Qato, PharmD, PhD, MPH, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, 1540 Alcazar St #236, Los Angeles, CA 90089. Email: qato@usc.edu.

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