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.
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.