P4A050: Glucagon Fills and Costs Among Children and Adolescents with Type 1 Diabetes, 2011-2021

Background: Compared to adults, children with diabetes are particularly susceptible to hypoglycemia due to variable eating patterns, fluctuations in activity levels, and difficulty detecting and communicating symptoms of hypoglycemia. Glucagon is a safe and effective treatment for severe hypoglycemia, and all patients at elevated risk for severe hypoglycemia should have easy access to glucagon. Historically, glucagon has been available as lyophilized powder that required reconstitution and injection. However, in 2019, the Food and Drug Administration granted pediatric approval for multiple easier-to-administer glucagon formulations, including intranasal, autoinjector, and pre-filled syringe products. This study characterizes trends in glucagon fill rates, costs, and disparities, and it assesses the impact of new, easier-to-administer formulations.

Methods: We conducted a retrospective cohort analysis using the OptumLabs® Data Warehouse claims database. We identified privately-insured children with Type 1 diabetes using Healthcare Effectiveness Data and Information Set claims-based definitions of diabetes. Data from 2011-2021 were included. Sociodemographic and clinical factors were collected over a one-year baseline period immediately preceding cohort entry. Glucagon fill rates and costs (total, out-of-pocket, health plan; standardized to 2021) were calculated per 1000 person-years. Cox regression was used to assess independent associations between clinical/sociodemographic factors and glucagon fills.

Results: We identified 13,267 children with Type 1 diabetes (mean age 12.3 [SD, 3.7] years, 47.7% female, 76.4% non-Hispanic White). Overall, 70.0% filled at least one prescription for glucagon during mean 2.81 [SD, 2.62] years of observation. Intranasal glucagon experienced rapid uptake, accounting for half of all glucagon fills in the first quarter of 2021, but there was no change in overall glucagon fill rates between 2011-2021. Family income was positively associated with glucagon fills in a stepwise fashion (HR 1.41 [95% CI 1.29-1.54] for annual household income ≥$200,000 vs. <$40,000), while Black race was negatively associated with fills (HR 0.78 [95% CI 0.71-0.85] as compared to White race. Total per-unit cost of glucagon increased from $154 in Q1 2011 to a maximum of $304 in Q3 2017 (+97%) before declining slightly to $280 in Q1 2021. Annual mean out-of-pocket costs ranged from $21-$68 (IQR $29-44) and showed no temporal trend.

Conclusion: Nearly 40% of children and adolescents with diabetes may lack access to unexpired glucagon, a potentially life-saving emergency treatment for hypoglycemia. Easier-to-administer formulations are increasingly common but have not improved overall fill rates. Concerningly, there are significant disparities among low-income, Black, and Hispanic patients, even within a universally insured cohort. Barriers to prescribing and obtaining glucagon need to be identified and addressed as health systems, clinicians, schools, and caregivers work together to ensure children have reliable access to this critical medication.