OBJECTIVES. To assess the epidemiology and economic burden of RRMS and SPMS in Italy, by using real-world data.

METHODS. Observational study based on secondary-use data from administrative databases of 3 Italian Local Health Units and 2 Regions. Patients were included in the study from 01/01/2010 to 31/12/2017 by ≥1 MS diagnosis code (ICD-9-CM code 340 and/or active exemption code 046) and/or ≥1 disease-modifying therapies (DMT). In the cohort, SPMS patients were identified by presence of ≥2 symptoms of MS progression or ≥2 drug prescriptions to treat these symptoms. MS patients not fulfilling SPMS criteria were included in the RRMS cohort. Mean annual healthcare costs (drugs, hospitalizations, outpatient services) were reported during follow-up stratified by treatment/untreatment condition. We also assessed costs of first and second-line DMTs during treatment course.

RESULTS. 9,543 MS patients (mean age 47.8±14.9, 34.6% male) were included in the study; 8,397 with RRMS (mean age 47.1±15.1, 34.1% male) and 1,146 with SPMS (mean age 53.1±11.2, 38.4% male). Estimated prevalence of MS was 141.6/100,000 inhabitants, of RRMS 124.4/100,000 and of SPMS 17.2/100,000. Mean annual cost per untreated and treated patient during follow-up was respectively: €3,638.21 and €11,795.69 (MS as a whole), €3,183.21 and €11,486.46 (RRMS), €6,317.42 and €15,511.76 (SPMS). Looking at DMTs during all available follow-up period, the mean length of treatment was 25.7 months for first-line and 24.5 for second-line, with a mean cost of €20,274.40 for first-line and €26,381.31 for second-line.

CONCLUSIONS. The study provided an updated epidemiologic analysis of MS, RRMS and SPMS in clinical practice setting in Italy. The prevalence reported was in line with the published literature. Mean annual costs tend to increase among SPMS patients compared to RRMS ones. The costs of first- and second-line DMTs were main drivers of the economic burden of MS.