Conference Posters Highlight Real-world Trends of Biosimilars, Reclassified Biologics

Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting examined the real-world patterns of biosimilar utilization and the impact of products that have been reclassified as biologics on Medicaid spending.

Real-world Patters of Oncology Biosimilars¹

Use of biosimilars was found to result in significant cost savings without requiring increased utilization other health care resources, suggesting that they are an ideal alternative to a reference, according to researchers at Intermountain Healthcare and SelectHealth.

Biosimilars offer patients and payers access to lower-cost alternatives to expensive reference products, and more research is needed to show the full financial and clinical impacts of increasing biosimilar utilization.

The researchers collected data on patient claims from SelectHealth, Medicaid, and commercial medial and pharmacy claims for bevacizumab, trastuzumab, and rituximab products between July 1, 2013 and September 21, 2021. In total, 1830 patients had claims for a reference product (Avastin, Herceptin, Rituxan, respectively) and 414 patients had claims for a biosimilar.

Two rituximab biosimilars (Truxima and Ruxience), 3 trastuzumab biosimilars (Ontruzant, Trazimera, and Kanjinti), and 2 bevacizumab biosimilars (Mvasi, Zirabev) were included in the analysis.

Biosimilars for the 3 molecules were found to be statistically significantly cheaper per claim, with cost per claim amounting to approximately $1056 less compared to claims for the reference products. The authors said that this could results in significant cost savings per year for patients and payers.

When claims were divided by the number of patients per product, there were no significant differences observed in supportive care claims between them, suggesting that further investigation into the supportive care space is needed.

Impact of Reclassified Biologic Products on Medicaid Spending²

Although the BPCIA’s follow-on pathways were effective at promoting follow-on competition among long-acting insulins, millions more in savings for Medicaid could have been provided if biologic reclassification was done in 2010 instead of 2020.

Furthermore, if reclassification occurred in 2010, development time, drug patents, and other barriers would likely have delayed competitive biosimilars from entering the market. However, the products may have been able to enter the market before 2021.

The BPCIA is the regulatory work that established the approval pathway for biologics and biosimilars. In 2020, some products, such as insulins, growth hormones, digestive enzymes, that were approved by the FDA using new drug applications were reclassified as biologics as a way to increase competition.

To understand the current level of market competition, the researchers collected data from the Medicaid State Drug Utilization Data between 1991 and 2021 for all reclassified drugs. Afterwards, they estimated the cost of the 10-year preparation period for long-acting insulin products, essentially providing another 10 years of exclusivity for the reference product (Lantus).

The estimated difference in gross reimbursement from 2010 and 2020 was found to be about $4.5 million in missed savings for Medicaid.

The investigators said that the ultimate impact of the BPCIA is still unknown and the introduction of Semglee (insulin glargine), the first biosimilar to receive interchangeability status in the United States, showed promise for additional insulin competition and future interchangeable biologic products.

Semglee entered the market in late 2020 and was automatically priced lower than Lantus and Basaglar. The authors theorized that net costs for insulin glargine could be further reduces as more competitive products like Semglee enter the market.

“Continuing this analysis in 5-10 years will reveal the actual impact of any additional competitors on the reimbursement levels for insulins, growth hormones, enzymes, and other biologic classes,” the investigators said.

Reference

1. Matlock AS, Koch C, Beal A. Real world healthcare costs, utilization, and treatment patterns of biosimilar oncology medication. Presented at: Academy of Managed Care Pharmacy 2022 Annual Meeting; March 29-April 1; Chicago, IL. Poster C15.
2. Carlson EL, Schondelmeyer SW. Estimating the impact of reclassified biologic products under the Biologics Price Competition and Innovation Act on Medicaid spending. Presented at: Academy of Managed Care Pharmacy 2022 Annual Meeting; March 29-April 1; Chicago, IL. Poster U41.