Financial Toxicity Associated with Biological Medicines: A Scoping Review.

Financial toxicity, defined as the economic burden experienced by patients due to medication and other healthcare costs and their consequences, such as material, psychosocial and behavioral effects, represents a significant concern for individuals receiving biological medicines. This scoping review synthesizes current evidence on financial toxicity connected to biological therapies and proposes policy interventions to mitigate its impact, while identifying key research gaps. A comprehensive literature search was conducted across databases Scopus, Medline, Web of Science, CINAHL, and EMB Reviews. The initial set of articles was screened in accordance with the PRISMA framework using Covidence software. After title/abstract and full-text screening, 24 studies were included in the final analysis. Data were synthesized guided by Witte's framework of financial toxicity, which distinguishes between objective financial burden (direct and indirect treatment costs) and subjective financial distress (material, psychosocial and behavioral effects). Findings indicate that high out-of-pocket expenses are the primary driver of financial toxicity among patients using biological medicines. These costs are often exacerbated by indirect expenses such as lost income, as well as insurance-related barriers including high co-payments. Although several studies acknowledged the subjective financial distress related to financial toxicity, this dimension was underreported, with few studies incorporating patient-reported outcomes or validated quality-of-life measures. This review reinforces the multifaceted nature of financial toxicity in the context of biological therapies and highlights the urgent need for support systems that address both economic and psychosocial challenges faced by patients. Future research should prioritize strategies to improve access to treatment while minimizing the financial burden.