Drug registration, reimbursement and proper use are not synonyms: the palivizumab case

Key words: Respiratory syncytial virus, Palivizumab, Clinical trials, International guidelines

Respiratory syncytial virus (RSV) is a common reason for hospitalization of infants. Data from clinical trials showed that palivizumab reduced RSV hospitalization rates for premature infants. However, according to different sources of information such as the Summary of Product Characteristics, (SPC) national and international guidelines (e.g., recommendations from Società Italiana di Neonatologia or from American Academy of Pediatrics), as to the criteria to be followed for reimbursements at national (Italian Medicine Agency’s limitations) and regional level (recommendations from Regional Health Service), prescribers might find several discrepancies regarding the characteristics of subpopulations that may benefit from this treatment. Different indications have been analysed taking into account the most recent available evidence regarding the efficacy and safety of the palivizumab. Furthermore, over the years, the collected epidemiological data regarding the risk of RSV hospitalization have helped to define the paediatric patients for whom the drug produces the best benefits.