Payer Controls Limiting Semglee Uptake Despite Patient Demand

Despite competition from an interchangeable biosimilar and an unbranded generic, branded insulin glargine (Lantus) has kept a hold of not only a majority of total market volume (78%) but also new drug starts (54%), according to a new report from the Biosimilars Council. Using data analyzed by IQVIA, the report tracks the adoption trend of biosimilar insulin by comparing Semglee, an interchangeable biosimilar, and its unbranded version with the reference product.

Since it launched in 2021, Semglee has seen modest uptake, with Medicare market share growing from only 3% to 6%. Semglee’s wholesale acquisition cost for the standard pack size and 30-day supply is not much lower than Lantus’ ($269 vs $292). The unbranded insulin glargine has a wholesale acquisition cost (WAC) of $99.

However, Sanofi, the maker of Lantus, will reduce the price 78% starting January 2024. In March 2023, Sanofi followed announcements from Novo Nordisk and Eli Lilly that it would significantly reduce the list price of its insulin product. In addition to the 78% price cut, the company will establish a $35 cap on out-of-pocket costs for patients with commercial insurance.

In the commercial space, Semglee has seen more success with 24% of new-to-brand (NBRx) starts; however, this is below the peak of 35% in early 2022. In comparison, unbranded biosimilar insulin glargine has market share ranging from 27% of NBRx in the commercial space to 52% of NBRx in managed Medicaid. The unbranded product’s uptake has been slow but consistent over the past 5 quarters, according to the data in the report.

“Demand (new patient written share) for unbranded Insulin Glargine has increased dramatically in the past year,” according to the report. “Insulin Glargine’s new written share increased from 25% to 49% from Q1-2022 to Q1-2023.”

Payer controls are limiting shares of NBRx. In the first quarter of 2023, only one-third of patients on Medicare who were prescribed Semglee actually received it. Less than one-fifth of patients on Medicare received unbranded insulin glargine when they were prescribed it. The analysis found that Semglee was not covered by 38% of Medicare payers and unbranded insulin glargine was not covered by 44%.

In addition, 2% of Medicare payers required prior authorization or step therapy for Semglee and 1% required them for unbranded insulin glargine.

In the commercial space, only 55% of patients prescribed Semglee received it and only 19% of unbranded insulin glargine prescriptions were filled. Semglee was not covered by 18% of commercial payers, and 3% required prior authorization/step therapy. Unbranded insulin glargine was not covered by 53% of commercial payers and 7% required prior authorization/step therapy.

The report concluded that lack of payer coverage is limiting biosimilar adoption with an estimate that Semglee would have achieved 17% NBRx market share in the commercial space, and unbranded insulin glargine would have achieved 49% with parity access.

“Biosimilar insulins are achieving greater market share, but persistent barriers, like rebate-driven formulary placement, restrict patient access to these lower-cost treatments,” Craig Burton, executive director of the Biosimilars Council, said in a statement. “The evidence is clear that biosimilar competition lowers drug prices for patients, so we should promote, not impede, greater competition in the insulin market and other biosimilar markets. Congress must act to eliminate the anti-competitive barriers hindering biosimilar access.”

Semglee was the first biosimilar offered through the pharmacy benefit in the United States, and in November 2022, IQVIA reported that the experience with Semglee could predict how the market would react to the introduction of adalimumab (Humira) biosimilars. The first adalimumab biosimilar launched January 31, 2023, and an additional 7 biosimilars launched in the first week of July.

Until the interchangeable version of Semglee launched, uptake for the biosimilar was slow for the first 10 months, and Lantus maintained 99% market share through November 2021, according to the IQVIA report from 2022.