OBJECTIVES: To estimate the cost-effectiveness of delayed-release dimethyl fumarate compared with glatiramer acetate and fingolimod in treatment of relapsing-remitting multiple sclerosis (RRMS) in the US.

METHODS: A cohort Markov model tracking patients through EDSS health states (cycle time 1 year) was developed in Excel to estimate the discounted (at 3 percent) cost and quality-adjusted life-years (QALYs) with treatment with delayed-release dimethyl fumarate compared with glatiramer acetate or fingolimod in RRMS. Patients were assumed to stop DMT when their EDSS reached 7.

Population characteristics matched those in the delayed-release dimethyl fumarate phase 3 clinical trials. Untreated transition rates between the EDSS health states and annualized relapse rates were estimated using data from the placebo arms of the phase 3 clinical trials. The impact of each DMT on disease progression and annualized relapse rates was estimated using a mixed-treatment comparison analysis of clinical trial data.

Costs included drug acquisition, administration, monitoring and adverse event costs as well as other costs in each EDSS health state. Utility by EDSS health state and disutility associated with adverse events were also included. One-way sensitivity analyses were performed changing input parameter values and model assumptions.

RESULTS: Over a 10-year time horizon, compared with glatiramer acetate and fingolimod, delayed-release dimethyl fumarate increased QALYs by 0.205 and 0.156 QALYs, respectively and was less costly by $8,094 and $30,522, respectively. Thus, delayed-release dimethyl fumarate was dominant (had lower costs and higher QALYs gained) compared to glatiramer acetate and fingolimod. Sensitivity analyses showed that delayed-release dimethyl fumarate was less costly and more effective than glatiramer acetate and fingolimod for most of the input parameter values and assumptions tested.

CONCLUSIONS: Delayed-release dimethyl fumarate, a new oral drug indicated for RRMS, is a cost-effective treatment when compared to glatiramer acetate and fingolimod. Sensitivity analyses support the robustness of the model results.