The economic impact, healthcare resource utilization, and clinical outcome over 24 months in patients with relapsing-remitting multiple sclerosis treated with dimethyl fumarate in Greece- The Fidelity Study.

BACKGROUND

The review of healthcare costs in multiple sclerosis (MS) has been of increased interest. In this study, we aimed to estimate the economic burden of MS patients, treated with dimethyl fumarate (DMF) in Greece.

RESEARCH DESIGN AND

METHODS

Four hundred and fifty-six participants were followed every 6 months after DMF initiation. Healthcare resource utilization, out-of-pocket expenses, and productivity loss data were recorded. Treatment cost and effectiveness of DMF were compared with those of previous treatments.

RESULTS

From a societal perspective, the total mean biennial burden was 13,113 € per patient, mainly attributed to direct healthcare costs (10,818 €, with medication accounting for almost 96%). From the payer perspective, the cost per patient was estimated at 10,462 €. The main driver of indirect cost was early retirement (87.8%). The treatment cost in the 2 years before the study was ~25% higher than the biennial DMF cost. A total of 43.9% of the patients experienced adverse events, mostly mild/moderate.

CONCLUSIONS

DMF displayed a societal cost mainly driven by medication, disease severity, disease duration and patients' age. There was evidence of beneficial effects on disease activity and quality of life with no new safety signals emerging.

TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (ID: NCT03101735).