Rivista di formazione e aggiornamento professionale del pediatra e del medico di base, fondata nel 1982. In collaborazione con l'Associazione Culturale Pediatri.
Login Abbonamenti Pubblicazioni Carrello Registrazione Perché registrarsi? Contatti

Farmacoriflessioni

Esiti neonatali e criteri di rimborso per il palivizumab

Neonatal outcomes and criteria for reimbursement of palivizumab

Antonio Addis, Valeria Belleudi, Francesco Trotta, Luigi Pinnarelli, Marina Davoli

Dipartimento di Epidemiologia della Regione Lazio, ASL Roma 1, Roma

Dicembre 2018 - pagg. 636 -640

Abstract
In 2016 the Italian Medicines Agency (AIFA) decided to limit the coverage of the prophylaxis with palivizumab following the American Academy of Pediatrics guidelines. In 2017 as a consequence of the strong debate that involved scientific societies, patients' associations and governing authorities, AIFA took a step back on its decision and restored the initial criteria. The present study assessed the impact of such governing measures on hospitalisations for respiratory syncytial virus (RSV) and the concomitant number of prescriptions of palivizumab for children aged < 2. During the considered four weeks (2014-2018) in the Lazio region 7,042 hospitalisations for respiratory viruses were observed in children aged < 2, of which 35.2% (no. = 2,476) for RSV. Following 2016-AIFA restrictions a decrease in the number of hospitalisations for RVS from 6.3 / 1,000 (95% CI from 6.0 to 6.7) to 5.5 / 1,000 (CI 95% from 5.0 to 5.9) was observed. In the same period the number of prescriptions of palivizumab concomitantly decreased by 48% (a saving of 750,000 euro for the National Health System). Therefore, the implementation of the new criteria for the reimbursement of palivizumab did not reflect an increase in the hospitalisation rate for RVS for children aged < 2, despite a significant decrease in the number of prescriptions of palivizumab.
Contenuto riservato

Per leggere l'articolo completo è necessario effettuare il login.

Non sei ancora registrato? Registrati

Bibliografia

1. Bont L, Checchia PA, Fauroux B, et al. Defining the Epidemiology and burden of severe respiratory syncytial virus infection among infants and children in Western Countries. Infect Dis Ther 2016;5(3):271-98. 2. Hall CB, Weinberg GA, Blumkin AK, et al. Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age. Pediatrics 2013;132(2);e341-8. 3. Frassanito A, Nicolai A, Nenna R, et al. Acute viral respiratory tract infections and wheezing at follow-up in children < 3 years. Eur Respir J 2015;46(Suppl 59):PA1319. 4. Ferrara M, Cangiano G, Papasso S, et al. Bronchiolitis: a 9 years epidemic seasons analysis. Eur Respir J 2014;44(Suppl 58): P1258. 5. Zuccotti G, Dilillo D, Zappa A, et al. Epidemiological and clinical features of respiratory viral infections in hospitalized children during the circulation of influenza virus A(H1N1) 2009. Influenza Other Respir Viruses 2011;5 (6):e528-34. 6. Corsello G, Di Carlo P, Salsa L, et al. Respiratory syncytial virus infection in a Sicilian pediatric population: risk factors, epidemiology, and severity. Allergy Asthma Proc 2008;29(2): 205-10. 7. Medici MC, Arcangeletti MC, Rossi GA, et al.; Osservatorio VRS Study Group. Four year incidence of respiratory syncytial virus infection in infants and young children referred to emergency departments for lower respiratory tract diseases in Italy: the “Osservatorio VRS” Study (2000-2004). New Microbiol 2006;29(1): 35-43. 8. Lanari M, Giovannini M, Giuffré L, et al.; Investigators R.A.DA.R. Study Group. Prevalence of respiratory syncytial virus infection in Italian infants hospitalized for acute lower respiratory tract infections, and association between respiratory syncytial virus infection risk factors and disease severity. Pediatr Pulmonol 2002;33(6):458-65. 9. Hall CB, Weinberg GA, Blumkin AK, et al. Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age. Pediatrics 2013;132(2):e341-8. 10. Impact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics 1998;102(3 Pt 1):531-7. 11. American Academy of Pediatrics, Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 2014;134(2):e620-38. 12. Robinson JL, Le Saux N; Canadian Paediatric Society, Infectious Diseases and Immunization Committee. Preventing hospitalizations for respiratory syncytial virus infection. Paediatr Child Health 2015;20(6):321-33. 13. Grindeland CJ, Mauriello CT, Leedahl DD, Richter LM, Meyer AC. Association between updated guideline-based palivizumab administration and hospitalizations for respiratory syncytial virus infections. Pediatr Infect Dis J 2016;35(7):728-32 14. Rajah B, Sánchez PJ, Garcia-Maurino C, Leber A, Ramilo O, Mejias A. Impact of the updated guidance for palivizumab prophylaxis against respiratory syncytial virus Infection: a single Center experience. J Pediatr 2017;181: 183-188.e1. 15. Farber HJ, Buckwold FJ, Lachman B, et al. Observed effectiveness of palivizumab for 29-36-week gestation infants. Pediatrics 2016; 138(2). 16. Buckley BC, Roylance D, Mitchell MP, Patel SM, Cannon HE, Dunn JD. Description of the outcomes of prior authorization of palivizumab for prevention of respiratory syncytial virus infection in a managed care organization. J Manag Care Pharm 2010;16(1):15-22. 17. Newby B, Sorokan T. Respiratory syncytial virus infection rates with limited use of palivizumab for infants born at 29 to 31+6/7 weeks gestational age. Can J Hosp Pharm 2017;70(1):13-8. 18. Resch B, Bramreiter VS, Kurath-Koller S, Freidl T, Urlesberger B. Respiratory syncytial virus associated hospitalizations in preterm infants of 29 to 32 weeks gestational age using a risk score tool for palivizumab prophylaxis. Eur J Clin Microbiol Infect Dis 2017;36(6): 1057-62. 19. Capizzi A, Silvestri M, Orsi A, Cutrera R, Rossi GA, Sacco O. The impact of the recent AAP changes in palivizumab authorization on RSV-induced bronchiolitis severity and incidence. Ital J Pediatr 2017;43(1):71. 20. Friedman DM, Domachowske JB, Wong PC, et al. Perceived risk of severe respiratory syncytial virus disease and immunoprophylaxis use among US pediatric specialists. Clin Pediatr (Phila) 2016;55(8):724-37. 21. Pignotti MS, Carmela Leo M, Pugi A, et al.; Palivizumab Consensus Group. Consensus conference on the appropriateness of palivizumab prophylaxis in respiratory syncytial virus disease. Pediatr Pulmonol 2016;51(10):1088-96. 22. Bollani L, Baraldi E, Chirico G, et al. Revised recommendations concerning palivizumab prophylaxis for respiratory syncytial virus (RSV). Ital J Pediatr 2015;41:97. 23. Addis A, Marchetti F, Bonati M. Registrazione, rimborso e uso appropriato dei farmaci non sono sinonimi: il caso del palivizumab. Medico e Bambino 2016;35(8):507-12. 24. Belleudi V, Trotta F, Pinnarelli L, Davoli M, Addis A. Neonatal outcomes following new reimbursement limitations on palivizumab in Italy. Arch Dis Child 2018;103:1163-7.

Corrispondenza: a.addis@deplazio.it