(82) Utilization, User Characteristics, and Adverse Outcomes of Insulin Glargine Originators and Follow-on Drug in Patients with Diabetes in the US

Publication Number: 1127

Background: Insulin glargine is a long-acting insulin used in patients with type 1 diabetes mellitus [T1DM] or T2DM. The first follow-on insulin glargine was approved in 2015 in the US, and information on its utilization and health outcomes in real-world settings is limited.

Objectives: To describe utilization, user characteristics, and adverse outcomes of the follow-on insulin glargine [follow-on drug] and insulin glargine originators to inform future comparative investigations.

Methods: We conducted a retrospective cohort study and analyzed healthcare claims data from 5 commercial health plans (>18 million person-years) in the Biologics & Biosimilars Collective Intelligence Consortium distributed research network in the US using the US Food and Drug Administration’s Sentinel analytic tools. We identified prevalent users and episodes (consecutive prescriptions, allowing an enrollment gap ≤45 days) of insulin glargine originators (Lantus, Toujeo, Soliqua) [OG] and follow-on drug (Basaglar) [FO] among patients with T1DM [PT1] or patients with T2DM [PT2] from 1/1/2011 up to 2/28/2021. We descriptively examined (without confounder-adjusted statistical comparisons) users’ characteristics in the 183-day baseline period prior to the index date (first recorded dispensing date of each episode) and prespecified adverse outcomes during post-index 183 days.

Results: We identified 508,438 users (5,544,116 episodes) of OG and 63,199 users (341,618 episodes) of FO. Mean ages (years) was similar in the FO and OG groups: 41.9 and 43.1 [PT1]; 61.2 and 61.0 [PT2]. The percentage of women was also similar: 42.1 and 43.3 [PT1]; 47.5 and 45.3 [PT2]. The number of episodes per 1,000 PT1 increased for FO (99 in 2017; 133 in 2020), whereas it decreased for OG (1,050 in 2017; 697 in 2020). Similar patterns were observed in PT2. The two groups (FO and OG) appeared to have similar percentages of episodes with baseline comorbidities of hypertension, diabetic retinopathy, and diabetic neuropathy in both PT1 and PT2. However, Charlson/Elixhauser combined comorbidity score was higher for FO: 0.8 vs 0.5 [PT1]; 1.4 vs 1.0 [PT2]. The percentages of episodes with post-index hyperglycemia, diabetic ketoacidosis [DKA], and hypoglycemia were higher for FO for both PT1 (hyperglycemia: 3.3 vs 1.7; DKA: 3.9 vs 2.5; hypoglycemia: 1.5 vs 1.2) and PT2 (hyperglycemia: 3.9 vs 2.4; DKA: 3.9 vs 2.3; hypoglycemia: 0.8 vs 0.7).

Conclusions: There was an increasing trend over time in the utilization of the follow-on insulin glargine. Further investigations comparing the safety and effectiveness between the follow-on drug and originators are needed.