Cost-Effectiveness of a Host-Response Point-of-Care Assay for Early Sepsis Diagnosis in UK Emergency Departments.

Abstract

Background: Early recognition of sepsis in emergency departments (EDs) improves outcomes and reduces healthcare resource use. However, current clinical practice (CCP), largely based on the National Early Warning Score 2 (NEWS2) and clinical judgement, has limited diagnostic sensitivity at presentation. Consequently, some patients with early sepsis are not promptly identified, resulting in delayed treatment, disease progression, and increased use of high-cost care. Rapid point-of-care host-response diagnostics may complement clinical assessment by identifying patients at risk who do not initially meet conventional clinical thresholds.

Objective: To estimate the cost-effectiveness of adding a rapid LPS-induced TNF-α release point-of-care assay (TARA) to current clinical practice, compared with procalcitonin (PCT) plus CCP and CCP alone, from the UK National Health Service (NHS) and Personal Social Services perspective, in line with NICE reference case methods.

Methods: A decision-analytic model simulated diagnostic classification, timing of sepsis recognition (early, delayed, late), initiation of antibiotic treatment, hospital admission (general ward or intensive care unit [ICU]), discharge, and readmission among adults presenting to UK EDs with suspected sepsis without shock. Model inputs included diagnostic accuracy, clinical outcomes, health-related quality of life, and costs derived from published literature and UK-relevant sources. The base-case time horizon was lifetime, to fully capture the QALY consequences of prevented deaths and long-term sequelae (ESRD, amputation); a 6-month scenario analysis was also conducted. Deterministic and probabilistic sensitivity analyses assessed parameter uncertainty.

Results: In the deterministic base-case analysis, TARA plus CCP was associated with lower total costs and higher quality-adjusted life-years (QALYs) compared with both comparator strategies. Cost savings were approximately £370 per patient versus PCT plus CCP and £1,822 per patient versus CCP alone, with incremental QALY gains of 0.0834 and 0.0836, respectively. In the probabilistic analysis, mean cost savings were £391 versus PCT plus CCP and £1,835 versus CCP alone. Benefits were driven primarily by reductions in false-negative diagnoses, leading to earlier treatment, lower ICU use, and reduced downstream hospital costs.

Conclusions: Integrating a rapid host-response point-of-care assay into ED sepsis pathways in the UK was associated with lower total costs (savings of approximately £370 per patient versus PCT plus CCP and £1,822 per patient versus CCP alone) and marginally higher quality-adjusted life-years (QALY gains of 0.0834 and 0.0836, respectively), driven by reductions in missed diagnoses and downstream use of high-cost care.