Ozempic, a relatively new anti-diabetes drug, has been in the headlines because of widespread shortages that are making it difficult for patients who use the drug to manage diabetes to access it. Some news articles suggest that off-label use for weight loss has been a factor associated with increased demand. The active ingredient in Ozempic is semaglutide, which helps regulate insulin production and blood sugar, but can also have the side-effect of significant weight loss. Wegovy, a drug with the same active ingredient as Ozempic but clinically indicated to treat obesity, was introduced in 2021. Following its introduction, demand for Wegovy skyrocketed, causing shortages shortly after the drug became available and leading providers to prescribe Ozempic off-label when patients are unable to get Wegovy.
To examine this reported trend in off-label use of Ozempic, we used HCCI data to look at how many Ozempic users in our data had a diabetes diagnosis and how this has changed over the period in which Ozempic has been available.
The Share of Ozempic Users with a Diabetes Diagnosis Declined by 16% from 2018 to 2021
We examined the percentage of new Ozempic users who had a diabetes or prediabetes diagnosis within one year prior to their first fill of Ozempic and found that this share has been decreasing since 2018, when it first became available. In 2018, 92% of new Ozempic users had evidence of a diabetes diagnosis; by 2021, this share had fallen to 77% of new Ozempic users.
Over the same period, the percentage of new Ozempic users in the HCCI data who had an obesity diagnosis without a diabetes or prediabetes diagnosis increased from about 4% in 2018 to 13% in 2021.
Early Data Hints that Costs to Patients May Play a Role in Off-Label Use
In addition to the lack of availability of Wegovy, individuals seeking medication for weight loss may turn to off-label use of Ozempic due to differences in the cost of the two drugs. Our data show that in 2021, the year Wegovy first became available, patients paid, on average, $213 out-of-pocket for a 30-day supply of Wegovy, compared to $51 dollars for Ozempic – over 4 times higher. We cannot account for coupons and other patient assistance that patients may receive to offset these out-of-pocket costs, however these programs are often limited in terms of monetary coverage or number of covered fills, leaving patients responsible for the full out-of-pocket amount after the coupon program ends. Given that these medications require long-term use, high out-of-pocket costs are likely to be a substantial financial burden for many people.
Our data show that, over time, an increasing percentage of Ozempic users do not have a diabetes diagnosis, suggesting increased off-label use. A number of factors, including drug shortages, coverage and benefit design, pricing, and celebrity promotion may play a role in this shift. The data presented here are from 2021, but current news points to ongoing issues of shortages and rising costs of these drugs for patients, calling for ongoing efforts to ensure appropriate and adequate access.
Our cohort includes beneficiaries who were continuously enrolled in an ESI plan for at least 1 year prior to and including the month of their first Ozempic prescription fill. For this cohort, we pulled all inpatient, outpatient, and physician claims to look for claims with a diabetes, pre-diabetes or obesity diagnosis in any diagnostic position. We counted those with diabetes as anyone with at least 1 claim with a diabetes or prediabetes diagnosis and counted those with obesity as anyone with at least 1 claim with an obesity diagnosis. This methodology has been used in prior research to identify on-label and off-label use of prescriptions.
To confirm that changes in diagnoses were not driven by decrease in general health care utilization in 2020-2021 due to the COVID-19 pandemic, we also checked the percentage of our cohort that had any medical claim in those years. The percentage decreased by less than 1% from 2019 to 2020 and 2021, so we do not believe that the general decrease in use of health care services during the pandemic explains the phenomena we observed in the data.
We calculated average out-of-pocket prices of 30-day supply fills for prescriptions of Ozempic and Wegovy products listed in the 2021 RxNorm file using claims data from the Health Care Cost Institute.
The average out-of-pocket price calculation was derived by summing the total out-of-pocket amounts on all drug claims, then dividing the sum by the sum of total days supplied. This gave us a unit out-of-pocket price per 1 day supply, which we multiplied by 30 to get the out-of-pocket price per 30-day supply. Note that out-of-pocket amounts for prescription drugs reflect negotiated discounts from wholesale or list prices but do not account for manufacturer rebates, coupons or other discount programs provided through separate transactions.