Análisis económico del tratamiento ambulatorio intermitente con levosimendán de la insuficiencia cardiaca avanzada en España / Economic analysis of intermittent intravenous outpatient treatment with levosimendan in advanced heart failure in Spain

INTRODUCCIÓN Y OBJETIVOS: La insuficiencia cardiaca (IC) avanzada conlleva altas tasas de hospitalización y mortalidad. El estudio LION-HEART fue un ensayo clínico aleatorizado y controlado con placebo que evaluó la eficacia y la seguridad de la administración intravenosa de dosis intermitentes de levosimendán en pacientes ambulatorios con IC avanzada. El objetivo del presente estudio es realizar un análisis de costes para determinar si la menor tasa de hospitalizaciones por IC observada en pacientes tratados con levosimendán en el estudio LION-HEART puede generar ahorros para el Sistema Nacional de Salud, en comparación con la opción de no tratar a los pacientes con IC avanzada. MÉTODOS: Se realizó un modelo económico que incluyó las tasas de hospitalización por IC del estudio LION-HEART y los costes de hospitalización por IC y de adquisición y administración intravenosa de levosimendán. El horizonte temporal del análisis fue de 12 meses. Se realizaron 2 análisis, uno determinístico y otro probabilístico (simulación de Monte Carlo de segundo orden). RESULTADOS: Según el análisis determinístico, el ahorro total por cada paciente tratado con levosimendán ascendería a -698,48 euros. En el análisis probabilístico, el ahorro por paciente tratado con levosimendán sería de -849,94 (IC95%, 133,12 a -2.255,31) euros. La probabilidad de que se produzcan ahorros con levosimendán en comparación con la opción de no tratar sería del 94,8%. CONCLUSIONES: El tratamiento ambulatorio intermitente con levosimendán puede generar ahorros para el Sistema Nacional de Salud, en comparación con la opción de no tratar a los pacientes con IC avanzada

INTRODUCTION AND OBJECTIVES: Advanced heart failure (HF) leads to high hospitalization and mortality rates. The LION-HEART study was a randomized, placebo-controlled clinical trial that evaluated the safety and efficacy of intravenous administration of intermittent doses of levosimendan in outpatients with advanced HF. The aim of the present study was to perform a cost analysis to determine whether the lower rate of hospitalizations for HF, observed in patients treated with levosimendan in the LION-HEART study, can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF. METHODS: An economic model was used that included IC hospitalization rates from the LION-HEART study, the costs of hospitalization due to HF and those of the acquisition and intravenous administration of levosimendan. The time horizon of the analysis was 12 months. Two analyses were carried out, one deterministic and the other probabilistic (second-order Monte Carlo simulation). RESULTS: In the deterministic analysis, the total saving for each patient treated with levosimendan would amount to−€698.48. In the probabilistic analysis, the saving per patient treated with levosimendan would be−€849.94 (95%CI, €133.12 to−€2,255.31). The probability of savings with levosimendan compared with the no treatment option would be 94.8%. CONCLUSIONS: Intermittent ambulatory treatment with levosimendan can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF

Economic analysis of intermittent intravenous outpatient treatment with levosimendan in advanced heart failure in Spain.

INTRODUCTION AND OBJECTIVES: Advanced heart failure (HF) leads to high hospitalization and mortality rates. The LION-HEART study was a randomized, placebo-controlled clinical trial that evaluated the safety and efficacy of intravenous administration of intermittent doses of levosimendan in outpatients with advanced HF. The aim of the present study was to perform a cost analysis to determine whether the lower rate of hospitalizations for HF, observed in patients treated with levosimendan in the LION-HEART study, can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF. METHODS: An economic model was used that included IC hospitalization rates from the LION-HEART study, the costs of hospitalization due to HF and those of the acquisition and intravenous administration of levosimendan. The time horizon of the analysis was 12 months. Two analyses were carried out, one deterministic and the other probabilistic (second-order Monte Carlo simulation). RESULTS: In the deterministic analysis, the total saving for each patient treated with levosimendan would amount to-€698.48. In the probabilistic analysis, the saving per patient treated with levosimendan would be-€849.94 (95%CI, €133.12 to-€2,255.31). The probability of savings with levosimendan compared with the no treatment option would be 94.8%. CONCLUSIONS: Intermittent ambulatory treatment with levosimendan can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF.

Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery.

OBJECTIVE: In the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial, no differences in clinical outcomes were observed between levosimendan and placebo in a broad population of patients undergoing cardiac surgery. In previous studies, the benefits of levosimendan were most clearly evident in patients undergoing isolated coronary artery bypass grafting (CABG) surgery. In a prespecified analysis of LEVO-CTS, we compared treatment-related outcomes and costs across types of cardiac surgical procedures. METHODS: Overall, 563 (66.4%) patients underwent isolated CABG, 97 (11.4%) isolated valve, and 188 (22.2%) combined CABG/valve surgery. Outcomes included the co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs. RESULTS: The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%). Ninety-day mortality was lower with levosimendan in isolated CABG (2.1% vs 7.9%; hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.11-0.64), but not significantly different in valve (8.3% vs 2.0%; HR, 4.10; 95% CI, 0.46-36.72) or combined procedures (10.4% vs 7.6%; HR, 1.39; 95% CI, 0.53-3.64; interaction P = .011). LCOS (12.0% vs 22.1%; odds ratio, 0.48; 95% CI, 0.30-0.76; interaction P = .118) was significantly lower in levosimendan-treated patients undergoing isolated CABG. Excluding study drug costs, median and mean 30-day costs were $53,707 and $65,852 for levosimendan and $54,636 and $67,122 for placebo, with a 30-day mean difference (levosimendan - placebo) of -$1270 (bootstrap 95% CI, -$8722 to $6165). CONCLUSIONS: Levosimendan was associated with lower 90-day mortality and LCOS in patients undergoing isolated CABG, but not in those undergoing isolated valve or combined CABG/valve procedures.