OBJECTIVES: To analyse the cost-effectiveness of treatment of relapsing remitting multiple sclerosis (RRMS) with cladribine tablets (CladT) and dimethyl fumarate (DMF) from the perspective of the National Health System (NHS) in Spain.

METHODS: A probabilistic Markov model (second-order Monte Carlo simulation) with a 10-year time horizon and annual Markov cycles was performed, based on a model developed by the Canadian Agency for Drugs and Technologies in Health (CADTH). Data on progression, relapses, treatment adherence, treatment continuation and utilities (quality-adjusted life years [QALYs]) were obtained from the medical literature. Univariate sensitivity analyses (modifying time horizon, cost of treatment continuation, and CladT and DMF purchase prices) were performed to confirm and provide robustness to the results.

RESULTS: CladT was the dominant treatment, with lower costs (-74,741 € [95% CI -67,247; -85,661 €]) and greater effectiveness (0.1920 [95% CI -0.1659; 0.2173] QALY) per patient, compared to DMF. CladT had a 95.1% probability of being cost-effective for a willingness to pay of €25,000 per QALY gained, and remained dominant across the scenario analyses tested. In that sense, the scenario analysed from a societal perspective, including labour costs, CladT was also dominant in 94.1% of the analyses. Both, the effect of CladT on disability progression derived from the indirect treatment comparison along with the savings in costs due to the CladT posology had a significant influence on the results. The QALY gain (0.1920) with CladT vs DMF was clinically relevant.

CONCLUSIONS: CladT is the dominant treatment (lower costs, with more QALYs) compared with DMF in the treatment of RRMS in Spain. These results serve as an important piece of evidence for policymakers, budget holders, and health advisers in decision-making when choosing among different treatment options for patients with RRMS.