OBJECTIVES: Delayed-release dimethyl fumarate (also known as gastro-resistant dimethyl fumarate, DMF) is an oral disease-modifying therapy used for the treatment of relapsing-remitting multiple sclerosis (RRMS). Aim of this economic analysis was to evaluate the cost effectiveness of DMF compared with teriflunomide in first-line treatment of RRMS in Italy, adopting both National Healthcare Service (NHS) and societal perspectives.

METHODS: Cost-effectiveness analysis (CEA) was developed through a Markov model with lifetime horizon. Outcomes were measured in terms of life years (LYs), quality-adjusted life years (QALYs), lifetime costs and incremental cost-effectiveness ratio (ICER). Efficacy of treatments, expressed as reduction of disability progression and relapse rate, were derived from an elaboration of a mixed treatment comparison. Utilities were retrieved from DMF clinical trials and MS survey. Relapses, adverse events, progression to secondary progressive MS were associated with disutilities. Both direct and indirect costs were captured. Unit costs were based on current Italian prices, tariffs, published literature. An annual 3.5% discount rate was applied to costs and outcomes. One-way deterministic and probabilistic sensitivity analyses were conducted, a cost-effectiveness acceptability curve was generated.

RESULTS: DMF was more efficacious than teriflunomide for both LYs (19.63 vs. 19.55) and QALYs (6.53 vs. 5.95). From NHS perspective, total costs per patient treated with DMF (€ 348,216) were slightly higher than with teriflunomide (€ 336,896). Resulting ICER was € 19,741 per QALY gained, significantly below the Italian willingness-to-pay threshold (€ 50,000 per QALY). From societal perspective, total costs per patient treated with DMF (€ 1.01 M) were lower than with teriflunomide (€ 1.03 M). DMF was dominant because more effective in terms of QALYs and less costly. Both sensitivity analyses confirmed robustness and reliability of base-case results.

CONCLUSIONS: Results of this CEA confirm that DMF may be an optimal first-line treatment for RRMS in both Italian NHS and societal perspectives.