Biosimilar Tocilizumab Shows Cost-Effectiveness Advantage in Spanish RA Population

A recent pharmacoeconomic analysis has found that subcutaneous biosimilar tocilizumab offers a cost-effective and cost-saving option for individuals with moderate to severe rheumatoid arthritis (RA) in Spain compared with commonly used biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs).

Biosimilar tocilizumab proves to be a cost-effective treatment for rheumatoid arthritis in Spain, enhancing access to advanced therapies. | Image credit: IHERPHOTO - stock.adobe.com

RA is the most prevalent chronic inflammatory rheumatic condition, with an estimated prevalence of 0.82% among adults in Spain, disproportionately affecting women aged 40 to 59 years—an age group typically in active employment.² Advances in biologic therapies have dramatically improved disease outcomes, but their high costs have limited widespread adoption. The introduction of biosimilars, which maintain the same benefit-risk profile at reduced prices, has prompted the need for updated cost-effectiveness assessments. Tocilizumab, an IL-6 receptor inhibitor, has been approved for RA in the European Union since 2009, and the launch of its biosimilar version created an opportunity to reexamine treatment value within Spain’s national health system.

Investigators developed a Markov model simulating a lifetime horizon with 3-month cycles. The model considered 5 health states: remission, low disease activity, moderate disease activity, high disease activity, and death. Effectiveness data were derived from a systematic literature review, including meta-analyses, network meta-analyses, and clinical trials. Transition probabilities between health states were estimated from published data, while pharmacologic costs were sourced from Spain’s BotPlus database and regional tariffs.

The baseline patient population reflected real-world Spanish demographics: individuals with RA had a mean age of 52.7 years, 80.6% were women, and the mean disease duration was 7.45 years. Quality-adjusted life-year (QALY) utilities were assigned based on disease activity, and a 3% discount rate was applied to costs and outcomes.

The analysis showed that lifetime treatment with biosimilar tocilizumab resulted in the lowest total cost per patient (€183,741), compared with €184,317 for infliximab and €201,972 for certolizumab, the most expensive comparator. In terms of effectiveness, QALYs ranged from 13.53 for rituximab to 13.74 for upadacitinib, with biosimilar tocilizumab yielding 13.73—on par with reference tocilizumab and sarilumab. The percentage of patients achieving remission was highest with upadacitinib (12.67%), followed closely by tocilizumab (12.61%) and sarilumab (12.58%). Incremental cost-effectiveness ratio analyses demonstrated that biosimilar tocilizumab was either dominant (less costly and more effective) or cost-effective across all comparisons. Sensitivity analyses further reinforced the robustness of the findings, with biosimilar tocilizumab maintaining a 100% probability of being cost-effective at Spain’s willingness-to-pay thresholds of €22,000 and €30,000 per QALY.

By providing equal clinical benefit at a lower cost, biosimilar tocilizumab has the potential to expand access to advanced RA therapy. The study authors emphasized, “What is more important about the introduction of biosimilars is that [the] efficacy of the treatment remains stable while costs are drastically reduced, entailing great benefits for the healthcare system and improving its efficiency.”

The study authors acknowledged several limitations. Assumptions were made regarding the distribution of patients across disease activity states, and long-term treatment effects were extrapolated beyond the duration of clinical trial data. Pricing was based on ex-factory costs rather than final reimbursed prices, which may have introduced uncertainty. Additionally, while the analysis was specific to Spain, external generalizability may be limited.

The evaluation concluded that biosimilar tocilizumab represents the most cost-effective and, in many cases, cost-saving option for treating moderate to severe RA in Spain. These findings may support broader biosimilar adoption as a strategy to balance clinical outcomes with economic sustainability in managed care.

References

1. Pérez-Ruiz F, Crespo-Diz C, Schoenenberger-Arnaiz JA, et al. Cost-effectiveness analysis of subcutaneous biosimilar tocilizumab in patients with rheumatoid arthritis in Spain. Farm Hosp. 2025;49(5):278-285. doi:10.1016/j.farma.2024.11.004

2. Silva-Fernández L, Macía-Villa C, Seoane-Mato D, et al. The prevalence of rheumatoid arthritis in Spain. Sci Rep. 2020;10(1):21551. doi:10.1038/s41598-020-76511-6