Cost-effectiveness of modified diagnostic strategy to safely rule-out pulmonary embolism in the emergency department: a non-inferiority cluster crossover randomized trial (MODIGLIA-NI).

BACKGROUND: The aim of this trial-based economic evaluation was to assess the incremental costs and cost-effectiveness of the modified diagnostic strategy combining the YEARS rule and age-adjusted D-dimer threshold compared with the control (which used the age-adjusted D-dimer threshold only) for the diagnosis of pulmonary embolism (PE) in the Emergency Department (ED). METHODS: Economic evaluation from a healthcare system perspective alongside a non-inferiority, crossover, and cluster-randomized trial conducted in 16 EDs in France and two in Spain with three months of follow-up. The primary endpoint was the additional cost of a patient without failure of the diagnostic strategy, defined as venous thromboembolism (VTE) diagnosis at 3months after exclusion of PE during the initial ED visit. Mean differences in 3-month failure and costs were estimated using separate generalized linear-regression mixed models, adjusted for strategy type, period, and the interaction between strategy and period as fixed effects and the hospital as a random effect. The incremental cost-effectiveness ratio (ICER) was obtained by dividing the incremental costs by the incremental frequency of VTE. RESULTS: Of the 1,414 included patients, 1,217 (86%) were analyzed in the per-protocol analysis (648 in the intervention group and 623 in the control group). At three months, there were no statistically significant differences in total costs (€-46; 95% CI: €-93 to €0.2), and the failure rate was non inferior in the intervention group (-0.64%, one-sided 97.5% CI: -∞ to 0.21%, non-inferiority margin 1.5%) between groups. The point estimate of the incremental cost-effectiveness ratio (ICER) indicating that each undetected VTE averted in the intervention group is associated with cost savings of €7,142 in comparison with the control group. There was a 93% probability that the intervention was dominant. Similar results were found in the as randomized population. CONCLUSIONS: Given the observed cost decrease of borderline significance, and according to the 95% confidence ellipses, the intervention strategy has a potential to lead to cost savings as a result of a reduction in the use of chest imaging and of the number of undetected VTE averted. Policy-makers should investigate how these monetary benefits can be distributed across stakeholders. CLINICALTRIALS: Trial registration number ClinicalTrials.gov Identifier: NCT04032769; July 25, 2019.

Estimation of the Width of Uncertainty in Care Consumption and Costs When Using Common Data Collection Tools in Economic Evaluations: A Benchmark for Sensitivity Analyses.

OBJECTIVES: This study aimed to evaluate the uncertainty related to the use of common collection tools to assess costs in economic evaluations compared with an exhaustive administrative database. METHODS: A pragmatic study was performed using preexisting cost-effectiveness studies. Patients were probabilistically matched with themselves in the French National Health Data System (Système National des Données de Santé [SNDS]), and all their reimbursed hospital and ambulatory care data during the study were extracted. Outcomes included the ratio of the number of each type of resources consumed using trial data (case report forms for ambulatory care and local hospital data for hospital care) versus the SNDS and the ratio of corresponding costs. Mean ratios and 95% confidence intervals (CIs) were calculated using bootstrapping. The impact of the collection tool on the result of the economic evaluation was calculated with the difference in costs between the 2 treatment arms with both collection methods. RESULTS: Five cost-effectiveness studies were included in the analysis. A total of 397 patients had the SNDS hospital data, and 321 had ambulatory care data. Common collection tools underestimated hospital admissions by 13% (95% CI 8-20), corresponding costs by 5% (95% CI 2-14), and ambulatory acts by 41% (95% CI 33-51), with large variations in costs depending on the study. There was no change in the economic conclusion in any study. CONCLUSIONS: The use of common collection tools underestimates healthcare resource consumption and its associated costs, particularly for ambulatory care. Our results could provide useful evidence-based estimates to inform sensitivity analyses' parameters in future cost-effectiveness analyses.

Cost-effectiveness of stepwise provisional versus systematic dual stenting strategies in patients with distal bifurcation left main stem lesions: economic analysis of the EBC MAIN trial.

BACKGROUND: In patients with distal bifurcation left main stem lesions requiring intervention, the European Bifurcation Club Left Main Coronary Stent Study trial found a non-significant difference in major adverse cardiac events (MACEs, composite of all-cause death, non-fatal myocardial infarction and target lesion revascularisation) favouring the stepwise provisional strategy, compared with the systematic dual stenting. AIMS: To estimate the 1-year cost-effectiveness of stepwise provisional versus systematic dual stenting strategies. METHODS: Costs in France and the UK, and MACE were calculated in both groups to estimate the incremental cost-effectiveness ratio (ICER). Uncertainty was explored by probabilistic bootstrapping. The analysis was conducted from the perspective of the healthcare provider with a time horizon of 1 year. RESULTS: The cost difference between the two groups was €-755 (€5700 in the stepwise provisional group and €6455 in the systematic dual stenting group, p value<0.01) in France and €-647 (€6728 and €7375, respectively, p value=0.08) in the UK. The point estimates for the ICERs found that stepwise provisional strategy was cost saving and improved outcomes with a probabilistic sensitivity analysis confirming dominance with an 80% probability. CONCLUSION: The stepwise provisional strategy at 1 year is dominant compared with the systematic dual stenting strategy on both economic and clinical outcomes.

End-of life medical spending and care pathways in the last 12 months of life: A comprehensive analysis of the national claims database in France.

BACKGROUND: To inform policy makers on efficient provision of end-of-life care, we estimated the 12-month medical expenditures of French decedents in 2015. METHODS: We estimated total medical expenditures by service type and diagnosis category, and analyzed care pathways for breast cancer, dementia, chronic obstructive lung disease. RESULTS: 501,121 individuals died in 2015, 59% of whom were in a hospital at the time of death. The aggregated spending totaled 9% of total health expenditures, a mean of €28,085 per capita, 44% of which was spent during the last 3 months of life. Hospital admissions represented over 70% of total expenditures; 21.3% of the population used hospital palliative care services in their last year of life. Analyses performed on breast cancer, dementia and lung disease found that differences in care pathways markedly influenced spending and were not simply explained by patients characteristics. CONCLUSION: Diagnoses and care trajectories, including repeated hospital stays, are the main drivers of the last year of life expenditures. Our data suggests that early identification of patients requiring palliative care and community-based end-of-life service delivery is feasible and could better support patients, families and caregivers with constant or reduced costs.