Cost-effectiveness of cladribine tablets and dimethyl fumarate in the treatment of relapsing remitting multiple sclerosis in Spain

Aim: To analyze the cost-effectiveness of treatment of relapsing remitting multiple sclerosis (RRMS) with cladribine tablets (CladT) and dimethyl fumarate (DMF) from the perspective of the Spanish National Health System (NHS). Methods: A probabilistic Markov model (second-order Monte Carlo simulation) with a 10-year time horizon and annual Markov cycles was performed. Results: CladT was the dominant treatment, with lower costs (-74,741 euro [95% CI: -67,247; -85,661 euro]) and greater effectiveness (0.1920 [95% CI: -0.1659; 0.2173] QALY) per patient, compared with DMF. CladT had a 95.1% probability of being cost-effective and a 94.1% chance of being dominant compared with DMF. Conclusion: CladT is the dominant treatment (lower costs, with more QALYs) compared with DMF in the treatment of RRMS in Spain. Plain language summary What was the aim of this research?To analyze the cost-effectiveness of treatment of relapsing remitting multiple sclerosis (RRMS) with cladribine tablets (CladT) and dimethyl fumarate (DMF) from the perspective of the Spanish National Health System (NHS). How was the research carried out?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. What were the results?CladT was the dominant treatment, with lower costs (-74,741 euro [95% CI: -67,247; -85,661 euro]) and greater effectiveness (0.1920 [95% CI: -0.1659; 0.2173] QALY) per patient, compared with DMF. CladT had a 95.1% probability of being cost-effective for a willingness to pay of 25,000 euro per QALY gained and remained dominant across the scenario analyses tested. In that sense, the scenario analyzed from a societal perspective, including labour costs, CladT was also dominant in 94.1% of the cases. The QALY gain (0.1920) with CladT versus DMF was clinically relevant. What do the results of the study mean?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 these patients.