Assessing the Value of Biosimilars: A Cost-Effectiveness Approach for Managed Care Organizations

Abstract

Biologic medications are essential for treating chronic diseases but come with high costs, prompting interest in biosimilars as more affordable alternatives. Biosimilars are highly similar to FDA-approved biologics in terms of safety and efficacy, though not identical. Managed Care Organizations (MCOs), especially those contracted by Medicaid in New York, play a key role in formulary management and cost containment. Despite over 600 approved biologics, only approximately 69 biosimilars are available, and their adoption varies widely. This study evaluates cost and clinical outcomes across three disease states—Rheumatoid Arthritis (RA), Crohn’s Disease (CD), and Type 1 Diabetes Mellitus (DM)—using biologic-biosimilar pairs: Adalimumab (Cyltezo), Infliximab (Avsola), and Insulin Glargine (Semglee). We aim to understand pricing discrepancies and the lag in biosimilar uptake within MCO formularies through cost-effectiveness analysis. Findings will inform whether clinical equivalence translates into formulary preference and support efficient resource allocation while maintaining patient access and treatment outcomes. A formulary review identified high-cost biologics with FDA-approved biosimilars used in managed care. RA, CD, and T1DM were selected based on prevalence and cost impact. Biologics included Humira, Remicade, and Lantus, with biosimilars Cyltezo, Avsola, and Semglee. Selection was based on FDA approval, formulary access, and clinical relevance. Efficacy and safety were confirmed through trial review and real-world data. Cost-effectiveness was assessed using ICER, calculated from annual treatment costs and clinical outcomes, with a $50,000 willingness-to-pay threshold. Biosimilars demonstrated strong cost-effectiveness compared to their reference biologics. Cyltezo showed better clinical response than Humira (69% vs 64.5%) at a much lower annual cost ($6600 vs $107,992.82), yielding an ICER of –$2.25 million. Avsola was also more effective than Remicade (68.1% vs 59.1%) and significantly cheaper ($24,000 vs $50,500), with an ICER of –$297,752.81. Semglee and Lantus had equivalent outcomes, but Semglee cost less ($1775.76 vs $4896), supporting a cost-minimization approach. Despite favorable outcomes, biosimilars were often placed on equal or higher formulary tiers than reference biologics due to rebate contracts, limited interchangeability, and provider hesitancy. Biosimilars offer equal or better clinical outcomes at much lower costs in RA, CD, and T1DM. Cyltezo and Avsola were dominant in both efficacy and cost, yet their formulary placement remains inconsistent due to rebate-driven incentives, provider hesitancy, and administrative barriers. To improve adoption, MCOs and PBMs should prioritize value-based formulary decisions, enhance transparency, and support provider and patient education. Pharmacists can help lead biosimilar use through counseling and substitution protocols. Greater alignment between clinical evidence and formulary practices can lower costs, improve access, and promote sustainable care.