This week, a research letter published in JAMA gives some insight into how biosimilars of long-acting insulins could impact the cost of insulin therapy for patients with diabetes.
The skyrocketing costs of insulin products are the subject of growing attention, particularly as insulins near their 2020 transition to regulation as biologics. Currently, insulins and a number of other therapies, like hormones, are regulated as drugs and follow-on products, but they will come under regulation as biologics and biosimilars in line with the “Deemed to be a License” provision in section 7002(e) of the Biologics Price Competition and Innovation Act. Once insulins are regulated as biologics, it will be possible for developers to seek interchangeable designations for their subsequent-entry versions, which will allow for pharmacy-level substitution and the potential for cost savings.
This week, a research letter published in JAMA gives some insight into how biosimilars of long-acting insulins could impact the cost of insulin therapy for patients with diabetes. The letter sought to describe changes in reimbursement and market share for long-acting insulins in Medicaid following the approval of Basaglar, a lower-cost follow-on insulin glargine referencing Lantus, as well as the approval of a concentrated insulin glargine, a long-acting insulin degludec, and a combination insulin glargine—lixisenatide.
Using Medicaid data, the researchers examined fee-for-service and managed care reimbursement records for long-acting insulins from the first quarter of 2005 to the second quarter of 2018, and calculated the mean amount reimbursed per 100 IU as well as each product’s market share.
Between 2008 and 2014, the brand-name Lantus accounted for approximately 80% of all reimbursed IUs for long-acting insulin. Insulin determir accounted for the remaining 20%. After new products were introduced, the market share for these 2 drugs decreased to 42% and 14%, respectively. By the first quarter of 2018, the market share for the follow-on insulin glargine, Basaglar, reached 34% for long-acting insulins, and 44% of all IU for insulin glargine.
Reimbursement rates for brand-name Lantus and insulin determir both increased by an average of 13% annually from 2006 to 2014, while Basaglar’s reimbursement rates were 15% to 16% lower than those of Lantus since it launched. Between the fourth quarter of 2016 to the second quarter of 2018, Basaglar generated more than $70 million in savings for Medicaid, or about 4.4% of all insulin glargine expenditures.
“In the long-acting insulin market, new product entry was associated with a halt in increases in reimbursement levels for incumbent products,” write the letter’s authors. “These findings suggest that increased competition in the long-acting insulin market was associated with lower per-milliliter reimbursements in Medicaid, lending support to policies that expedite biosimilar approval and market entry,” they conclude, adding that more savings will be possible with the advent of interchangeable biosimilar insulins.
Reference
Hernandez I, Good CB, Shrank WH. Trends in Medicaid prices, market share, and psending on long-acting insulins, 2006-2018 [published online March 25, 2018]. JAMA. doi: doi:10.1001/jama.2019.2990.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.