OBJECTIVES: Semaglutide (Ozempic^®) is a GLP-1 receptor agonist approved in 2017 as maintenance treatment for Type 2 diabetes (T2D), though reports indicate an increased usage as treatment for weight loss. The purpose of this study was to investigate off-label usage of semaglutide in the United States.

METHODS: This was a retrospective analysis of the Inovalon MORE² closed claims database of Commercial, Medicare Advantage, and Managed Medicaid beneficiaries. Adult patients were segmented into calendar year-based cohorts for years 2018-2022, which required continuous medical and pharmacy coverage for each year of interest. The prevalence of patients presenting ≥1 prescription for semaglutide with and without a corresponding ICD-10-CM diagnosis code for T2D (on- vs. off-label) was assessed each year, along with provider specialty, and patient characteristics segmented by on- vs. off-label status.

RESULTS: Between 31.3 and 37.2 million patients qualified for each calendar year sample. From 2018-2022, the number of patients treated with semaglutide increased from 19,171 to 359,999, which corresponds to a proportional increase of 1,840%. Off-label usage of semaglutide increased 256% from 2018-2022 (p < 0.001), with 6.2% of patients receiving the treatment off-label in 2018 compared to 22.1% by 2022. A variety of provider specialties were associated with semaglutide prescriptions, including family practitioners, psychiatrists, and sleep medicine specialists. In 2022, compared to patients receiving semaglutide on-label, patients receiving it off-label were younger (45.7 vs. 54.3 years), and more likely to be commercially insured (69.6% vs. 51.5%), female (80.7% vs. 60.1%), and have an obesity diagnosis (64.9% vs. 56.0%; all p <0.05).

CONCLUSIONS: By 2022, over one in five patients prescribed semaglutide were receiving it off-label, with an unexpected mixture of medical specialists associated with this treatment. Given news of a recent semaglutide shortage, payers and providers should take this into consideration and prioritize its availability for T2D patients in need of additional glycemic control.