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Biosimilar Competition May Fail to Lower Out-of-Pocket Costs for Patients

Despite hopes for lower out-of-pocket (OOP) costs with biosimilar competition, research published in JAMA Network finds that patient spending on biologic drugs remained the same, indicating the need for policy interventions to ensure affordability.

The US spends over $500 billion on prescription drugs annually, driven by high-cost biologics that require special physician administration. Biosimilars, which offer similar effectiveness at lower prices, have generated substantial savings and are projected to save billions more in the coming years. While biosimilar competition may reduce overall health care costs, it is unclear if individual patients using biologics will see a significant decrease in OOP expenses.

Data for this study was obtained from the Optum Clinformatics Data Mart, an administrative health claims database of insured individuals, with approval from the Massachusetts General Brigham Institutional Review Board. The cohort study focused on outpatient medical claims for biologics with FDA-approved biosimilar versions available before January 2021. Patients included in the study were adults under 65 years old with commercial insurance plans; inpatient claims were excluded from the analysis. The primary outcome measured was patient OOP costs for biologics and biosimilars.

Two analyses assessed the association between biosimilar competition and OOP costs. Trends in annual OOP costs were evaluated for up to 4 years before and after the availability of biosimilars. Additionally, a comparison was made between OOP spending per claim for reference biologics and biosimilar versions. Statistical analysis involved logistic regression and generalized linear regression models adjusted for patient and clinical characteristics. Sensitivity analyses were performed to assess the robustness of the findings.

A study analyzed 7 biologics facing new biosimilar competition between November 2013 and July 2019. These drugs treat various conditions such as cancers, hematologic disorders, and inflammatory diseases. The study identified 1.7 million claims from over 190 000 individuals who used these biologics from 2009 to 2022. Trends in OOP costs showed an increase in patients with nonzero OOP costs and higher mean costs after biosimilars entered the market.

The analysis focused on 1.3 million claims from over 145 000 individuals occurring before and after biosimilar competition began. They found that the percentage of patients with nonzero OOP spending increased over time. OOP spending varied by drug, with some biologics showing lower costs after biosimilar entry. In a comparison of biosimilars vs reference biologics, biosimilar claims were more likely to have nonzero OOP costs, but the mean costs were lower than reference biologics in most cases.

“Findings of this cohort study suggest that biosimilar competition was not consistently associated with lower OOP costs for commercially insured outpatients, highlighting the need for targeted policy interventions to ensure that the savings generated from biosimilar competition translate into increased affordability for patients who need biologics,” researchers said. 

Reference
Feng K, Russo M, Maini L, Kesselheim AS, Rome BN. Patient out-of-pocket costs for biologic drugs after biosimilar competition. JAMA Health Forum. 2024;5(3):e235429. doi:10.1001/jamahealthforum.2023.5429