Medicare formulary restrictions for glucagon-like peptide 1 receptor agonists and sodium glucose cotransporter 2 inhibitors used in type 2 diabetes mellitus: 2019-2023.

Abstract

Glucagon-like peptide 1 receptor agonists (GLP1-RAs) and sodium glucose cotransporter 2 inhibitors (SGLT2is) have proven benefits in patients with type 2 diabetes mellitus related to decreasing cardiovascular events and heart failure hospitalizations as well as preventing the progression of kidney disease. This led the American Diabetes Association (ADA) to update their guidelines in 2022 to recommend GLP1-RAs and SGLT2is as potential first-line options in patients with cardiorenal conditions. Formulary restrictions, such as step therapy and prior authorizations, can limit access to these beneficial medications. To evaluate trends in Medicare formulary restrictions of GLP1-RAs and SGLT2is following the recommendations by the ADA for first-line use. We conducted a retrospective cohort study of Quarter 1 Medicare formulary restrictions on GLP1-RAs and SGLT2is from 2019 to 2023. We analyzed changes in formulary restrictions by year, before and after the ADA first-line recommendations, single vs combination products, and products with and without other indications on a medication level (ie, each unique National Drug Code number on each unique formulary) and formulary level (ie, any prior authorization or step therapy requirements yield formulary restriction). We analyzed 12,212 unique Medicare formularies. GLP1-RAs were 12.5% less likely (relative risk [RR] = 0.87; 95% CI = 0.84-0.91; P < 0.001) and 33.2% less likely (RR = 0.67; 95% CI = 0.60-0.74; P < 0.001) to have restrictions after the ADA guideline changes on a medication and formulary level, respectively. SGLT2is were 87.8% less likely (RR = 0.12; 95% CI = 0.11-0.13; P < 0.001) and 53.0% less likely (RR = 0.47; 95% CI = 0.27-0.80; P = 0.005) to have restrictions after the ADA guideline changes on medication and formulary levels, respectively. Decreasing trends of medications and formularies with restrictions may indicate payers are recognizing GLP1-RAs and SGLT2is as potential first-line agents, aligning with ADA recommendations.