Neonatal outcomes following new reimbursement limitations on palivizumab in Italy

Objective To evaluate the impact of new reimbursement decisions for palivizumab treatment on respiratory syncytial virus (RSV) hospitalisations and the concomitant number of palivizumab prescriptions for infants aged Design We compared the RSV hospitalisation rates in infants before and after implementation of new limitations during three RSV seasons 2014–2017. Setting Population aged Patients Out of 70 323 infants, 5895 (8.4%) premature babies (gestational age (GA) Intervention In 2016, AIFA, following the American Academy of Pediatrics guidelines, decided to limit coverage of palivizumab prophylaxis (GA ≤29 weeks). Main outcomes measures Trend of hospitalisations by months and rate of RSV before-after new restrictions were analysed. Palivizumab prescriptions and costs for National Health Service (NHS) were considered. Results In a population of 284 902 aged Conclusions Implementation of the new palivizumab reimbursement criteria was not associated with an increase in the RSV hospitalisation rate for children aged