Abstract
To estimate the prevalence of MS, RRMS and SPMS patients and to evaluate their pharmaco-utilization and healthcare costs in a real-world setting. Observational retrospective study based on administrative databases of Italian Entities. Patients were identified as MS if between 01/01/2010-31/12/2017 they had ≥1 MS diagnoses (ICD-9-CM:340) and/or exemption code (046) and/or ≥1 disease-modifying therapies (DMTs). MS patients were recognized as SPMS by presence of ≥2 hospitalizations with diagnosis of at least one symptom related to MS progression or by ≥2 subsequent drug prescriptions to treat symptoms of MS progression. RRMS cohort comprised MS patients excluding SPMS cohort. During 12-months after first DMT, switch (presence of a different DMT) and treatment interruption (no DMT during last trimester) were evaluated, as well as treatment mix. Costs included drugs, hospitalizations, outpatient services. MS prevalence was estimated of 131.6/100,000 inhabitants; RRMS 114.7/100,000, SPMS 16.9/100,000. 3,516 MS patients (mean age 44.1±13.1, 34.3% male) were included: 3,051 (mean age 43.1±13.1, 33.4% male) with RRMS, 465 (mean age 51.1±10.7, 40.4% male) with SPMS. Proportion of patients treated within 3-months after inclusion was 48.3%(MS), 50.3%(RRMS) and 33.8%(SPMS); in all available period post-inclusion was 57.4%(MS), 59.8%(RRMS), 40.5%(SPMS); in all available period post-inclusion and 1-year pre-inclusion was 64.5%(MS), 66.8%(RRMS), 47.8%(SPMS). DMT switch was observed in 8.0% of MS, 8.2% of RRMS and 5.9% of SPMS cohorts; 14.1%(MS), 12.8%(RRMS) and 27.1%(SPMS) of patients stopped their treatment. Interferons (IFN β-1A and IFN β-1B) were the most prescribed DMT: 54.6%(MS), 56.6%(RRMS) and 33.9%(SPMS). Mean annual cost per treated patient was €11,025(MS), €10,784(RRMS), €13,544(SPMS). Administrative database analysis allowed to identify MS, RRMS and SPMS patients, highlighting the major prevalence of RRMS compared to SPMS. SPMS patients recorded the highest treatment interruption rate and cost per patient, thus showing the greater burden versus RRMS. Costs are affected by the most frequently prescribed type of DMT.
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