Coverage, Formulary Restrictions, and Out-of-Pocket Costs for Sodium-Glucose Cotransporter 2 Inhibitors and Glucagon-Like Peptide 1 Receptor Agonists in the Medicare Part D Program

“The Centers for Medicare & Medicaid Services recently announced a voluntary plan to cap out-of-pocket costs associated with insulin products in participating enhanced Part D plans. However, this model will not apply to other high-cost glucose-lowering medications such as sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists. These classes are increasingly used as second-line agents for patients with type 2 diabetes despite only a modest effect on glycemic control (approximately 0.8% to 1%) because of mounting evidence of cardiovascular benefits. We sought to examine contemporary coverage and out-of-pocket costs for beneficiaries filling either an SGLT2 inhibitor or GLP-1 receptor agonist prescription in Medicare Part D.

[..] This cross-sectional study used the 2019 quarter 1 Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files to assess drug coverage, formulary restrictions, median retail prices, and annual out-of-pocket costs associated with commonly used SGLT2 inhibitors and GLP-1 receptor agonists across Part D plans (both stand-alone and Medicare Advantage). [..] we report estimates for only the most commonly dispensed National Drug Code according to Medicaid State Drug Utilization Data for 2019 and that represented the drug label’s recommended maintenance dose. We excluded combination products because they are infrequently used. We calculated the percentage of Part D plans that covered each drug without formulary restrictions, defined as having no prior authorization and no step therapy requirements. We also calculated the median retail price and interquartile range (IQR) for a 30-day supply for each drug.

[..] Excluding ertugliflozin and lixisenatide (which were covered by only 6% and 3% of plans, respectively), coverage without prior authorization and without step therapy requirements ranged from 53.2% (95% CI, 49.1%-57.4%) for canagliflozin to 95.4% (95% CI, 94.3%-96.4%) for empagliflozin. Median retail prices for a 30-day supply ranged from $300 (IQR, $285-$303) for ertugliflozin to $942 (IQR, $931-$969) for liraglutide.

[..] Median estimated annual out-of-pocket costs ranged from $1211 (IQR, $1167-$1221) for ertugliflozin to $2447 (IQR, $2441-$2464) for liraglutide with the standard Part D benefit design. In comparison, median out-of-pocket costs with an algorithm based on plan-specific benefits data were lower, ranging from $1097 (IQR, $932-$1271) for empagliflozin to $2080 (IQR, $1771-$2648) for exenatide.

[..] Medicare beneficiaries not eligible for low-income subsidies or Medicaid potentially face very high out-of-pocket costs for SGLT2 inhibitors and GLP-1 receptor agonists. With the exception of less commonly prescribed drugs such as lixisenatide and ertugliflozin, the average beneficiary covered by a Part D plan could spend at least $1000 annually for 1 SGLT2 inhibitor and greater than $1500 for 1 GLP-1 receptor agonist. Although these products are used less frequently than insulin, these annual out-of-pocket costs are on par with—and in some cases exceed—those associated with insulin,* and may be unaffordable for the hundreds of thousands of older adults with diabetes and elevated cardiovascular risk who may receive clinical benefit from one of these newer agents.

[..] our results may overestimate out-of-pocket costs for these drugs among patients who would have reached catastrophic coverage because of simultaneous use of multiple higher-cost drugs. Some beneficiaries may also be insulated from high out-of-pocket costs through patient assistance programs. Although median retail prices do not include proprietary rebates, they do influence the amounts patients pay as coinsurance.”

*The authors referenced this paper that projected yearly out-of-pocket costs for insulin for Part D beneficiaries in 2019 was $1329.

Full article, Luo J, Feldman R, Rothenberger SD et al. JAMA Network Open 2020.10.15