Biosimilar Tocilizumab Cost-Effective for Treatment of Rheumatoid Arthritis in Spain

Biosimilar tocilizumab (RoActemra; TCZ) improved outcomes of patients with rheumatoid arthritis (RA) living in Spain and saved health care costs compared with other treatments, suggesting a promising avenue for enhancing patient care and optimizing resource allocation, according to a study published in Farmacia Hospitalaria.1

Patients diagnosed with RA experience high economic and humanistic burdens based on increased costs for the appropriate management of the disease and the associated morbidity. In Spain, about 5% of the total burden of rheumatic diseases are a result of RA. The prevalence of RA is increasing while mortality is decreasing, mainly in high-income countries where better management of disease control is practiced.

The development of biological disease modifying anti-rheumatic drugs (bDMARDs) altered the treatment paradigm 20 years ago, leading to improvements in disease control, less steroid consumption, and the attainment of a better overall quality of life. Disease effect and its progression are largely impacted by the bDMARDs. 

The European Commission approved TCZ for the treatment of moderate-to-severe RA in 2009 under Roche manufacturing.2 TCZ is noted as the first interleukin-6 receptor and inhibits monoclonal antibodies. The drug is indicated to be combined with methotrexate among patients with RA who responded inadequately or were intolerant to bDMARDs or tumor necrosis factor-α antagonists.

The current biosimilar therapeutic alternatives for RA management include abatacept, adalimumab, baricitinib, certolizumab, etanercept, golimumab, infliximab, rituximab, sarilumab, tofacitinib, upadacitinib, and TCZ.1 The study aimed to develop a cost-effectiveness analysis of subcutaneous biosimilar TCZ for the treatment of RA compared with the most common alternatives in Spain through a health care lens.

The systemic literature review included 13 studies that demonstrated efficacy, meta-analyses, and a series of clinical trials for alternative treatments. The Disease Activity Score 28 (DAS28) had thresholds for each of the 4 health status categories: remission (DAS28 < 2.6); low disease activity (2.6 ≤ DAS28 ≤ 3.2); moderate disease activity (3.2 < DAS28 ≤ 5.1); and high disease activity (DAS28 > 5.1).

After 52 weeks of treatment, better performance was recognized after TCZ, upadacitinib, certolizumab, and filgotinib use. Patients with moderate-high disease activity status at 52 weeks were treated with rituximab, golimumab, and etanercept.

Higher levels of remission status were found among patients taking upadacitinib (12.67%), TCZ (12.61%), and sarilumab (12.58%). The quality-adjusted life years (QALYs) were 13.73 for both TCZ and sarilumab while upadacitinib obtained 13.74 values. Biosimilar TCZ had the lowest total cost per patient (€183,741), followed by infliximab (€184,317). Certolizumab displayed the highest cost per patient (€201,972) compared with biosimilar TCZ and infliximab.

The incremental cost-effectiveness ratio for patients in remission health status or QALY showed the biosimilar TCZ was either dominant or cost-effective compared with the alternative drugs. The most influential factors in variability of the results were the probability of transition from remission to low disease activity health status, long-term costs of biosimilar TCZ, and probability of transition from low to moderate disease activity health status.

Across all scenarios, biosimilar TCZ was the most cost-effective treatment option. There was a 100% chance biosimilar TCZ was cost-effective when compared with the other treatment options for both the €30,000 and the €22,000 thresholds that Spain uses often.

The ex-factory prices are used in this analysis because final reimbursed prices are not publicly available, which could have impacted the results. Biosimilars should be utilized earlier in the treatment setting to leverage all potential benefits. Reports in Spain have found increased biosimilar adoption would allow additional patients to be treated by redirection of savings, improved health care resource allocation, and better patient 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. Farmacia Hospitalaria. Published online December 1, 2024. doi:10.1016/j.farma.2024.11.004
2. Nataloni R. Tocilizumab approved for rheumatoid arthritis in Europe. Medscape. January 23, 2009. Accessed January 14, 2025. https://www.medscape.com/viewarticle/587253