Farmacoriflessioni
Registrazione, rimborso e uso appropriato dei farmaci
non sono sinonimi: il caso del palivizumab
Drug registration, reimbursement and proper use are not synonyms: the palivizumab case
Antonio Addis1, Maurizio Bonati2, Federico Marchetti3
1Dipartimento di Epidemiologia, Regione Lazio, Roma
2Laboratorio per la Salute Materno Infantile, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milano
3UOC di Pediatria e Neonatologia, Ospedale di Ravenna, AUSL della Romagna
Ottobre 2016 - pagg. 507 -512
Abstract
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.
Parole chiave
Suggerite dall'AI
Classificazione MeSH
Bibliografia
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Corrispondenza: a.addis@deplazio.it