[The efficiency (cost-effectiveness) of palivizumab as prophylaxis against respiratory syncytial virus infection in premature infants with a gestational age of 32-35 weeks in Spain]. / La eficiencia (coste-efectividad) de palivizumab como profilaxis para la infección por virus respiratorio sincitial en prematuros de 32-35 semanas en España.

OBJECTIVES: To evaluate the efficiency (cost-effectiveness) of palivizumab in preventing severe respiratory syncytial virus (RSV) infection in premature infants with a gestational age of 32-35 weeks (GA 32-35) and two or more risk factors (RF) in Spain. DESIGN: decision tree model using data from the scientific literature and the FLIP I and FLIP II studies (cohort of 326 infants with GA 32-35 and two or more RF who received palivizumab) sponsored by the Spanish Society of Neonatology. Main effectiveness measure: quality-adjusted life years (QALY) gained. PERSPECTIVES: the national health service (NHS), which includes direct costs (administration of palivizumab and hospital admissions), and the societal perspective, which also includes indirect costs (the child's future lost productivity). Discount: 3 % annually for effectiveness and indirect costs. Sensitivity analysis: construction of 37 scenarios modifying variables related to effectiveness and costs. RESULTS: Prophylaxis with palivizumab in premature infants with GA 32-35 and two or more RF produced an incremental cost-effectiveness ratio (ICER) of 13,849 euro/QALY from the NHS perspective, and an ICER of 4,605 euro/QALY from the societal perspective. In the sensitivity analysis, from the NHS perspective the ICER ranged from 5,351 euro/QALY (most favorable scenario) to 23,276 euro/QALY (least favorable scenario). CONCLUSIONS: Palivizumab is a cost-effective therapy as prophylaxis against RSV in infants with GA 32-35 and two or more RF. Its use is efficient from the NHS perspective, since the cost of a QALY, even in the least favorable scenarios, is lower than the threshold of 30,000 Euro/QALY considered socially acceptable in Spain.

La eficiencia (coste-efectividad) de palivizumab como profilaxis para la infección por virus respiratorio sincitial en prematuros de 32-35 semanas en España / The efficiency (cost-effectiveness) of palivizumab as prophylaxis against respiratory syncytial virus infection in premature infants with a gestational age of 32-35 weeks in Spain

Objetivos Evaluar la eficiencia (coste-efectividad) de palivizumab para prevenir la infección grave por virus respiratorio sincitial (VRS) en prematuros de edad gestacional de 32 a 35 semanas (EG 32-35) y dos o más factores de riesgo (FR) en España. Métodos Diseño: modelo de decisión alimentado con datos de la literatura científica y de los estudios FLIP I y FLIP II (cohorte de 326 niños con EG 32-35 y dos o más FR que recibieron palivizumab) promovidos por la Sociedad Española de Neonatología. Medida de efectividad principal: años de vida ajustados por calidad (AVAC) ganados. Perspectivas: la del Sistema Nacional de Salud (SNS), que incluye los costes directos (administración de palivizumab e ingresos hospitalarios), y la perspectiva social, que incluye además los costes indirectos (futura productividad perdida del niño). Descuento: 3 % anual para la efectividad y costes indirectos. Análisis de sensibilidad: construcción de 37 escenarios modificando variables relacionadas con la efectividad y los costes. Resultados La profilaxis con palivizumab en prematuros de EG 32-35 y dos o más FR produce una relación de coste-efectividad incremental (CEI) de 13.849 euros/AVAC con la perspectiva del SNS, y de 4.605 euros/AVAC con la perspectiva social. En el análisis de sensibilidad, con la perspectiva del SNS, el CEI osciló de 5.351 euros/AVAC (escenario más favorable) a 23.276 euros/AVAC (escenario menos favorable). Conclusiones Palivizumab es una terapia coste-efectiva como profilaxis frente a VRS en niños de EG 32-35 y dos o más FR. Su uso es eficiente desde la perspectiva del SNS, al conseguir un AVAC, incluso en los escenarios menos favorables, por debajo del umbral de 30.000 euros/AVAC, considerado en España como socialmente aceptable

Objectives To evaluate the efficiency (cost-effectiveness) of palivizumab in preventing severe respiratory syncytial virus (RSV) infection in premature infants with a gestational age of 32-35 weeks (GA 32-35) and two or more risk factors (RF) in Spain. Methods Design: decision tree model using data from the scientific literature and the FLIP I and FLIP II studies (cohort of 326 infants with GA 32-35 and two or more RF who received palivizumab) sponsored by the Spanish Society of Neonatology. Main effectiveness measure: quality-adjusted life years (QALY) gained. Perspectives: the national health service (NHS), which includes direct costs (administration of palivizumab and hospital admissions), and the societal perspective, which also includes indirect costs (the child's future lost productivity). Discount: 3 % annually for effectiveness and indirect costs. Sensitivity analysis: construction of 37 scenarios modifying variables related to effectiveness and costs. Results Prophylaxis with palivizumab in premature infants with GA 32-35 and two or more RF produced an incremental cost-effectiveness ratio (ICER) of 13,849 euros/QALY from the NHS perspective, and an ICER of 4,605 euros/QALY from the societal perspective. In the sensitivity analysis, from the NHS perspective the ICER ranged from 5,351euros/QALY (most favorable scenario) to 23,276 euros/QALY (least favorable scenario). Conclusions Palivizumab is a cost-effective therapy as prophylaxis against RSV in infants with GA 32-35 and two or more RF. Its use is efficient from the NHS perspective, since the cost of a QALY, even in the least favorable scenarios, is lower than the threshold of 30,000 euros/QALY considered socially acceptable in Spain