Impact of Increased Use of Single-Inhaler Triple Therapies on COPD Exacerbation Rates, Mortality, and Total Costs: PROMETHEUS France.

Background: COPD is the seventh-leading cause of death in France. The randomized controlled trials ETHOS (NCT02465567) and IMPACT (NCT02164513) have demonstrated a reduction in exacerbations (primary endpoint) and suggest a decrease in mortality (secondary endpoint) with single-inhaler triple therapy (SITT)-containing a long-acting beta-2 agonist, long-acting anticholinergics, and an inhaled corticosteroid-in patients with COPD. No study has evaluated the potential impact of increased SITT use in France. Objective: To evaluate the impact of increased SITT use in COPD on exacerbations, mortality, and medical costs in France. Methods: A stochastic model was constructed using GOLD therapeutic recommendations and literature data on patient characteristics, prevalence, incidence, treatment distribution, COPD severity and treatment changes, mortality, and exacerbations to model the French COPD population. Two scenarios were studied: Status Quo (no increase in SITT use) and Increased SITT, using the GOLD stage and exacerbation history to initiate SITT treatment in modeled patients, considering the annual probabilities of transitioning from one GOLD stage to another over a 10-year period. Results: Increased SITT use compared to the Status Quo over a 10-year period could reduce severe and moderate exacerbations by 8.0% and 9.2%, respectively, all-cause mortality by 8.5%, and medical costs by 875 million euros (excluding additional SITT costs), and extend the life of patients by 0.6 years per patient with COPD. Conclusion: The model shows that increased SITT use in France, in line with recent recommendations, could be associated with a reduction in exacerbation rates, mortality, and costs in patients with COPD.