Indacaterol/Glycopyrronium versus Salmeterol/Fluticasone in Patients with COPD-A Cost-Effectiveness Analysis in the Czech Republic.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) represents an illness with significant healthcare and societal impacts. Fixed combinations of long-acting beta-agonists (LABA) and inhaled corticosteroids have been used for COPD treatment as the standard of care for many years. A daily dose of indacaterol and glycopyrronium (IND/GLY) at 110/50 µg has recently been gaining attention due to its improved efficacy and tolerability versus the standard of care.The study aims to evaluate the cost-effectiveness of once daily IND/GLY vs. twice daily salmeterol/fluticasone propionate (SFC) at 50/500 µg in COPD patients. METHODS: A microsimulation model in MS Excel was adapted to the Czech setting. Effectiveness data and disease severity stages were obtained from the FLAME study, which is a head-to head trial comparing IND/GLY vs. SFC. Quality of life data were derived from a literature review. Costs (medication, monitoring and complications) were taken from published Czech sources. The incremental cost-effectiveness ratio (ICER) was expressed as cost per quality-adjusted life year (QALY) gained. Costs and outcomes were discounted at 3 %. A lifetime horizon was used for the analysis. Cost-effectiveness was studied from the perspective of a health care system in the Czech Republic. RESULTS: Mean QALYs were higher in the IND/GLY arm (difference 0.167 QALYs). The ICER of IND/GLY compared with SFC was €13,628 per QALY gained. Deterministic sensitivity analyses and probabilistic sensitivity analyses confirmed the base-case result to be robust. CONCLUSIONS: From the perspective of the Czech health care system, managing COPD using IND/GLY is cost-effective in this analysis because the base-case is clearly below the willingness-to-pay threshold in the Czech Republic, which is automatically set at 3 times GDP/capita (approximately €44,000/ QALY). This is the first available economic analysis utilizing FLAME study results in the Central East European (CEE) countries showing IND/ GLY as a highly cost-effective investment into COPD patients.

[Chronic obstructive pulmonary disease--acute bacterial exacerbations]. / Chronická obstrukcní plicní nemoc - akutní bakteriální exacerbace.

COPD (Chronic obstructive pulmonary disease) belongs to leading causes of morbidity and mortality worldwide and results in substantial and everincreasing medical, social and economic burden. The same applies to the Czech Republic as well. To combat the disease the Global Initiative for Obstructive Lung Disease (GOLD) has been founded in collaboration with the World Health Organization (WHO). GOLD guideline was published in April 2001 and its Czech version appeared in November 2001. The prevention and management of acute exacerbations of COPD forms one of the basic chapters of the document. A COPD exacerbation is defined as sustained worsening of the patient's condition compared to the stable state and beyond normal day-to-day variations that is acute in onset and may warrant additional treatment in a patient with known COPD. COPD exacerbations can be triggered by both an acute infection (viral or bacterial) and noninfectious cause (air pollution events, cold weather, interruption of regular treatment). Accurate diagnosis and assessment of the severity of COPD exacrbation, adequate therapy including rational application of antibiotics, accurate indication for hospitalization and timely admission to an intensive care unit decrease the COPD -associated mortality.