| Summary: | Giorgio L Colombo,1,2 Sergio Di Matteo,2 Marta Vinci,3 Claudia Gatti,4 Maria Paola Pascali,5 Mario De Gennaro,6 Elena Macrellino,7 Giovanni Mosiello,5 Tiziana Redaelli,7 Francesca Schioppa,7 Cristina Dieci8 1University of Pavia, Department of Drug Sciences, School of Pharmacy, Pavia, Italy; 2S.A.V.E. Studi Analisi Valutazioni Economiche, Milan, Italy; 3Associazione Walter Vinci Onlus, Milan, Italy; 4Centro Spina Bifida, Azienda Ospedaliera di Parma, Parma, Italy; 5Centro Spina Bifida, Ospedale Pediatrico Bambino Gesù, Rome, Italy; 6Ospedale Pediatrico Bambino Gesù, O.C. di Urodinamica, Rome, Italy; 7Centro Spina Bifida, Ospedale Niguarda Milan, Italy; 8ASBI Associazione Spina Bifida Italia, Piacenza, Italy Introduction: Spina bifida (SB) is a congenital malformation of the spinal cord, nerves, and adjacent covering structures, with different levels of severity and functional disability. The economic cost of spina bifida and its prevention using folic acid have never been estimated in Italy. This study was conducted to define the cost of illness of SB in Italy. Methods: A retrospective multicenter observational study on the social cost of patients with SB was carried out in three SB centers in Italy. Cost data were collected relating to the 12 months preceding the enrollment time (T0), and subsequently 3 months after the T0 time (±20 days) through a case report form designed to collect the relevant information on the costs incurred during the period considered. The data for all patients were analyzed through multivariate analysis on the main parameters. Results: We enrolled 128 patients equally divided between males and females, with a mean age of 13 years (minimum, 0; maximum, 29). Diagnosis was mostly postnatal, with 64 cases diagnosed at birth and 33 cases diagnosed subsequently. The lesion severity levels, as defined in the inclusion criteria, were walking (52 patients); walking with simple orthoses (33 patients); walking with complex orthoses (16 patients); and nonwalking, (25 patients). The anatomic type identified is open SB in most cases (84 patients), followed by closed SB (37 patients) and SB occulta (3 patients). The most significant cost per year was for assistive devices, for a total of 4307.00 €, followed by hospitalization (907.00 €), examinations (592.00 €), and drug therapy (328.00 €). Cost breakdown by age range shows that the highest costs are incurred in the 0–4 age range. The highest cost was for cases of open SB (12,103.00 €). The cost/degree of severity ratio showed that the highest cost was for nonwalking patients (14,323.00 €), followed by patients walking with complex orthoses (13,799.00 €). Conclusion: The data from this study show that the mean total cost for a patient with SB was 11,351.00 € per year. Based on data provided by the Italian Institute of Health, we can estimate a total annual social cost of about 60 million Euros per year for SB in Italy. Cost of illness was correlated with age and degree of severity of SB. Keywords: spina bifida, cost of illness, pharmacoeconomics, cost analysis
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