Cost effectiveness of palivizumab in Spain: an analysis using observational data
Tóm tắt
To assess the cost effectiveness of palivizumab for prevention of severe respiratory syncytial virus (RSV) disease in high-risk infants in Spain, incorporating country-specific observational hospitalisation data. An existing decision tree model, designed using data from a large international clinical trial of palivizumab versus no prophylaxis, was updated to include Spanish observational hospitalisation data. The analysis was performed for preterm children born at or before 32 weeks gestational age, who are at high risk of developing severe RSV disease requiring hospitalisation. Data sources included published literature, official price/tariff lists and national population statistics. The primary perspective of the study was that of the Spanish National Health Service in 2006. The base-case analysis included the direct medical costs associated with palivizumab prophylaxis and hospital care for RSV infections. Use of palivizumab produces an undiscounted incremental cost-effectiveness ratio (ICER) of €6,142 per quality-adjusted life-year (QALY), and a discounted ICER of €12,814/QALY. Palivizumab provides a cost-effective method of prophylaxis against severe RSV disease requiring hospitalisation among preterm infants in Spain.
Tài liệu tham khảo
Simoes, E.A.: Respiratory syncytial virus infection. Lancet 354(9181), 847–852 (1999)
Canfield, S.D., Simoes, E.A.: Prevention of respiratory syncytial virus (RSV) infection: RSV immune globulin intravenous and palivizumab. Pediatr. Ann. 28(8), 507–514 (1999)
Clark, S., Beresford, M., Subhedar, N., Shaw, N.: Respiratory syncytial virus infection in high risk infants and the potential impact of prophylaxis in a United Kingdom cohort. Arch. Dis. Child. 83, 313–316 (2000)
Groothuis, J.R., Simoes, E.A., Levin, M.J., et al.: Prophylactic administration of respiratory syncytial virus immune globulin to high-risk infants and young children. The Respiratory Syncytial Virus Immune Globulin Study Group. N. Engl. J. Med. 329, 1524–1530 (1993)
The PREVENT Study Group: Reduction of RSV hospitalisation among preterm infants and infants with bronchopulmonary dysplasia using respiratory syncytial virus immune globulin prophylaxis. Pediatrics 99, 93–99 (1997)
The IMpact Study Group: Palivizumab, a humanised respiratory syncytial virus monoclonal antibody, reduces hospitalisation from respiratory syncytial virus infection in high risk infants. Pediatrics 102, 531–537 (1998)
Carbonell Estrany, X., Quero Jimenez, J.: Comité de Estándares de la Sociedad Española de Neonatología, y Junta Directiva de la Sociedad Española de Neonatología. Recomendaciones para la prevención de la infección por virus respiratorio sincitial. An Esp Pediatr 52(4), 372–374 (2000)
Sigurs, N., Bjarnason, R., Sigurbergsson, F., Kjellman, B.: Respiratory syncytial virus bronchiolitis in infancy is an important risk factor for asthma and allergy at age 7. Am. J. Respir. Crit. Care Med. 161(5), 1501–1507 (2000)
Sampalis, J.S.: Morbidity and mortality after RSV-associated hospitalisations among premature Canadian infants. J. Pediatr. 143(5 Suppl), S150–S156 (2003)
Joffe, S., Ray, G.T., Escobar, G.J., Black, S.B., Lieu, T.A.: Cost-effectiveness of respiratory syncytial virus prophylaxis among preterm infants. Pediatrics 104(3 Pt 1), 419–427 (1999)
The European Medicines Agency: http://www.emea.eu.int/index/indexh1.htm, accessed December 2007
Feltes, T.F., Cabalka, A.K., Meissner, H.C., et al.: Cardiac Synagis Study Group. Palivizumab prophylaxis reduces hospitalisation due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J. Pediatr. 143, 532–540 (2003)
Bont, L., van Aalderen, W., Kimpen, J.: Long term consequences of respiratory syncytial virus (RSV) bronchiolitis. Paediatr. Respir. Rev. 1, 221–227 (2000)
Sigurs, N., Bjarnason, R., Sigurbergsson, F., Kjellman, B., Bjorksten, B.: Asthma and immunoglobulin E antibodies after respiratory syncytial virus bronchiolitis: a prospective cohort study with matched controls. Pediatrics 95, 500–505 (1995)
Simoes, E.A.F., Carbonell-Estrany, X., Kimpen, J., Rieger, C.H.L., Morris, D.D., Pollack, P.F., Groothuis, J.R.: Palavizumab use decreases risk of recurrent wheezing in preterm children. Eur. Respir. J. 24(Suppl 48), 212s (2004)
Nuijten, M.J., Wittenberg, W., Lebmeier, M.: Cost effectiveness of palivizumab for respiratory syncytial virus prophylaxis in high-risk children: a UK analysis. Pharmacoeconomics 25(1), 55–71 (2007)
Lázaro y de Mercado, P., Figueras Aloy, J., Domenech Martinez, E., et al.: 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. An Pediatr (Barc) 65(4), 316–324 (2006)
Pedraz, C., Carbonell-Estrany, X., Figueras-Aloy, J., Quero, J., IRIS Study Group: Effect of palivizumab prophylaxis in decreasing respiratory syncytial virus hospitalisations in premature infants. Pediatr. Infect. Dis. J. 22(9), 823–827 (2003)
Nuijten, M.J.C.: Data management in modelling studies: the selection of data sources. Pharmacoeconomics 3(3), 305–316 (1998)
Pinto-Prades, J.L., Ortún-Rubio, V., Puig-Junoy, J.: El análisis coste-efectividad en sanidad. Aten Primaria 27, 275–278 (2001)
Simpson, S., Burls, A.: A systematic review of the effectiveness and cost-effectiveness of palivizumab (Synagis®) in the prevention of respiratory syncytial virus (RSV) infection in infants at high risk of infection. A West Midlands Development and Evaluation Service Report Department of Public Health & Epidemiology. University of Birmingham Edgbaston, Birmingham B15 2TT. ISBN No. 0704423219 Copyright, West Midlands Health Technology Assessment Group Department of Public Health and Epidemiology. University of Birmingham (2001)
Instituto Nacional de Estadística (INE).: Datos demográficos básicos, esperanza de vida al nacimiento. Disponible en: http://www.ine.es/(consultado en septiembre de 2005)
Greenough, A., Alexander, J., Burgess, S., et al.: Health care utilisation of prematurely born, preschool children related to hospitalisation for RSV infection. Arch. Dis. Child. 89, 673–678 (2004)
Personal communication with Dr P Lázaro y de Mercado: Técnicas Avanzadas de Invetigatión en Servicios de Salud, April 2007
Retribuciones del personal sanitario.: Generalitat de Valencia. Available at http://www.dival.es. (Accessed August 2005)
Carbonell-Estrany, X., Quero, J., Bustos, G., Cotero, A., Domenech, E., Figueras-Aloy, J., Fraga, J.M., Garcia, L.G., Garcia-Alix, A., Del Rio, M.G., Krauel, X., Sastre, J.B., Narbona, E., Roques, V., Hernandez, S.S., Zapatero, M.: Rehospitalisation because of respiratory syncytial virus infection in premature infants younger than 33 weeks of gestation: a prospective study. IRIS Study Group. Pediatr. Infect. Dis. J. 19(7), 592–597 (2000)
Orden 234/2005, de 23 de febrero, del Consejero de Sanidad y Consumo, por la que sefijan los precios públicos por la prestación de los servicios y actividades de naturaleza sanitaria de la Red de Centros de la Comunidad de Madrid. Boletín Oficial de la Comunidad de Madrid (BOCM) núm. 56, 8 de Marzo de, 2005
Bont, L., Aalderen, W.M., Kimpen, J.L.: Long-term consequences of respiratory syncytial virus (RSV) bronchiolitis. Paediatr. Respir. Rev. 1(3), 221–227 (2000)
Greenough, A., Cox, S., Alexander, J., et al.: Health care utilisation of infants with chronic lung disease, related to hospitalisation for RSV infection. Arch. Dis. Child. 85(6), 463–468 (2004)
Instituto Nacional de Estadística (INE).: Contabilidad Regional de España. Available at http://ine.es. (Consulted in January 2006)
Laufer, F.: Thresholds in cost-effectiveness analysis—more of the story. Value Health 8(1), 86–87 (2005)