Presentation (CTI)

OBJECTIVES: Immune checkpoint inhibitors have improved outcomes in advanced cutaneous squamous cell carcinoma and other malignancies; however, treatment-related adverse drug reactions (ADRs) may increase healthcare resource utilization and associated costs. Evidence on the economic implications of cemiplimab-related ADRs in Brazil remains limited. This study evaluated the healthcare resource utilization burden associated with cemiplimab-related ADRs reported in Brazil using real-world pharmacovigilance data.
METHODS: A retrospective descriptive analysis was conducted using publicly available reports from VigiMed between 2018 and 2025. Reports containing “Cemiplimab,” “Cemiplimabe,” or “Cemiplimab rwlc” in the active substance field (WHODrug) were identified. Indicators of healthcare resource utilization included hospitalization or prolonged hospitalization, treatment interruption or discontinuation, serious adverse events, and fatal outcomes. Descriptive analyses were performed to characterize the potential economic burden associated with ADR management.
RESULTS: A total of 52 individual reports comprising 102 cemiplimab-related ADR records were identified. The mean patient age was 69 years, with 47% female patients. Serious ADRs accounted for 49% of reported events. Hospitalization or prolonged hospitalization occurred in 16% of cases, indicating substantial inpatient resource utilization. Additionally, 20% of ADRs resulted in treatment interruption or discontinuation, potentially affecting treatment effectiveness and increasing downstream healthcare costs. Fatal outcomes were reported in 14% of cases. The most frequent serious-event classification was “other medically significant condition” (19%). Overall, the frequency of serious outcomes suggests a considerable resource burden associated with the management of cemiplimab-related ADRs.
CONCLUSIONS: Cemiplimab-related ADRs may generate meaningful healthcare resource utilization in Brazil through hospitalization, prolonged hospitalization, treatment interruption, and severe clinical outcomes. These findings highlight the importance of incorporating real-world safety evidence into economic evaluations, budget impact analyses, and reimbursement decision-making. Strengthening pharmacovigilance systems may improve the estimation of treatment-related resource use and support more informed healthcare resource allocation.