OBJECTIVES: The objective of this economic analysis was to compare the cost-effectiveness of dimethyl-fumarate vs teriflunomide for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) in the Italian setting. Providing estimation of relapse burden and disability progression at different time points during patients’ life.

METHODS: A Markov model was used to conduct the cost-effectiveness analysis. The model measured health outcomes and costs of RRMS patients treated with either dimethyl-fumarate or teriflunomide. Data from a published mixed treatment comparison were used for efficacy and safety input. Local economic data were used to calculate costs. A supplementary analysis was carried out to assess ICER variability over time from the Italian National Healthcare Service (NHS) and societal perspectives. Further analyses were conducted to compare clinical effectiveness of the alternatives over time, in terms of incidence of relapse, percentage of patients with EDSS (Expanded Disability Status Scale) score <=3 and EDSS score >=6.

RESULTS: In the base-case analysis (lifetime horizon; societal perspective) dimethyl-fumarate was dominant over teriflunomide (6.526 vs 5.953 QALYs; €1.01 M vs €1.03 M, respectively). The most relevant costs savings (for patient) with dimethyl-fumarate regarded relapses (-€5,096), inpatient care (-€5,767), informal care (-€9,603), long-term absence/early retirement (-€14,187). The additional analysis of ICER by time horizon shows that dimethyl-fumarate is cost-effective (i.e. ICER < € 50,000 per QALY gained) at already 6 years and at 15 years in societal or NHS perspectives, respectively. Results favoured dimethyl-fumarate vs teriflunomide also for: cumulative burden of relapses (-0.23 and -1.37 relapses saved per patient at 1 year or 10 years, respectively), proportion of patients with EDSS<=3 (+4.0% at 10 years) and with EDSS>=6 (-4,0% at 10 years).

CONCLUSIONS: Dimethyl-fumarate is cost-effective or dominant (more effective and less costly) vs teriflunomide for the first-line treatment of relapsing-remitting multiple sclerosis in Italian setting.