Epidemiological data on primary progressive multiple sclerosis (PPMS) are scarce. This study was aimed to evaluate the burden of PPMS in Italy with healthcare resources utilisation and costs for Italian National Health System (INHS). A 2-year cross-sectional analysis of real-world data collected in the ARCO database, covering > 10 million Italian inhabitants, was performed. From a cohort of patients affected by MS in 2014, those supposedly affected by PPMS were defined by the concurrent matching of absence of disease-modifying treatments and use of rehabilitation services. Any other drug prescriptions, outpatient services and hospitalisations were analysed in 2015 for each subject. The average annual cost per patient was provided both for each expenditure item and by integrating these. Of 13,253,591 inhabitants, 18,453 resulted affected by MS (prevalence 139 × 100,000). Of these, 1849 agreed with additional criteria to identify PPMS (10% of MS population). The 26.8% of these experienced at least one admission in 1 year, 97.3% used at least one outpatient service and 94.3% received at least one reimbursed drug. In the perspective of INHS, PPMS generated an average annual cost of € 3783 per person: 49% for hospitalisations, 28% for outpatient services and 23% for drugs. This study provides a reliable estimation of the PPMS burden in Italy, in terms of healthcare utilisation and direct costs. These findings could be useful to estimate the changes in health expenditure following the incoming of new drugs to treat PPMS with increase of pharmaceutical cost and potential decrease of rehabilitation and hospitalisation costs.
Keywords: Administrative databases; Burden of disease; Italy; Primary progressive multiple sclerosis; Real-world evidence.