Cost-Effectiveness of Blinatumomab for Pediatric High-Risk Relapsed Acute Lymphoblastic Leukemia in Brazil: An Economic Evaluation Using Real-World Data.
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OBJECTIVES: To evaluate the cost-effectiveness of blinatumomab compared with consolidation chemotherapy in pediatric patients with high-risk relapsed B-cell acute lymphoblastic leukemia from the perspective of the Brazilian Unified Health System. METHODS: A partitioned survival model with 3 health states (event-free survival, postevent survival, and death) was developed over a lifetime horizon. Parametric survival models were fitted to clinical trial data from Locatelli et al, and treatment effects were incorporated using hazard ratios under the proportional hazards assumption. Real-world data from a retrospective cohort of pediatric patients treated at a tertiary public hospital were used to inform cost inputs, resource utilization, and dosing assumptions. Health-state utility values were obtained from published literature. Costs and outcomes were discounted at an annual rate of 5%. Parameter uncertainty was assessed through deterministic and probabilistic sensitivity analyses (5000 Monte Carlo simulations). RESULTS: Blinatumomab was associated with higher costs and improved outcomes compared with consolidation chemotherapy. Patients treated with blinatumomab achieved 11.73 life-years and 9.96 quality-adjusted life-years (QALYs), compared with 8.36 life-years and 6.74 QALYs with chemotherapy, resulting in incremental gains of 3.37 life-years and 3.22 QALYs. The incremental cost was R$ 340 490.07, yielding an incremental cost-effectiveness ratio of R$ 101 035.63 per life-year gained and an incremental cost-utility ratio of R$ 105 742.26 per QALY gained. Sensitivity analyses confirmed the robustness of these findings, with most probabilistic simulations falling below the willingness-to-pay threshold. CONCLUSIONS: Blinatumomab is associated with improved clinical outcomes and represents a cost-effective alternative to consolidation chemotherapy for pediatric patients with high-risk relapsed B-cell ALL within the Brazilian Unified Health System under commonly referenced willingness-to-pay thresholds.