OBJECTIVES: Semaglutide, is a GLP-1 molecule FDA-approved to treat Type 2 Diabetes(Ozempic), while the same molecule also approved to treat Obesity(Wegovy). Medicare Part D plans may cover Ozempic, but are prohibited from covering Wegovy, creating an obvious demand for off-label prescriptions of Ozempic. Beyond legal prohibitions, allowing off-label prescribing would increase plan costs and generate adverse selection, putting an insurer at a competitive disadvantage. Our study provides early evidence on off-label use of Ozempic in Medicare.

METHODS: Using a 20% sample of Part D patients from 2018-2021. We identify patient’s first fill for Ozempic and determine the likelihood of off-label use based on past and future claims. Our criteria consider both the existence of diagnosis codes for diabetes and prescription fills of non-Semaglutide diabetic medicines. Prescriptions without clear evidence of diabetes were considered possibly off-label. We compared the rate of such fills across patient and plan characteristics.

RESULTS: We identified 138,128 first administrations of Ozempic, 32,408(23.46%) had no previously recorded code for diabetes and 14,973(10.8%) had no previous drug claim for any diabetes medication. 6,760(4.89%) had neither a previous diagnosis claim nor a previous diabetic medication fill. Patients whose first use was identified as ‘possibly off-label’, received a greater amount of Ozempic(9.2MG vs 7.8MG), paid more out-of-pocket $87 vs $77), and more likely to be on Medicare Advantage.

Plan features, including tier, coverage, and utilization management were all similar for on versus off-label patients. Of patients who received Ozempic possibly off-label, 3,122 (46.2% of 6,760 and 2.26% overall) continued to have no diagnosis code or non-Ozempic diabetes diagnosis filled in our observed follow-up.

CONCLUSIONS: Our results present early evidence that there is some off-label use of Ozempic in the Medicare program. However, important caveats about the ability of claims data to examine off-label use, including the comprehensiveness and fidelity of diagnosis codes apply.