OBJECTIVES: To analyse the cost-utility of treatment of relapsing remitting multiple sclerosis (RRMS) with cladribine tablets (CladT) and dimethyl fumarate (DMF) from the societal perspective 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. Data on progression, relapses, adherence, treatment continuation, utilities (quality-adjusted life years [QALYs]) and costs were obtained from the literature and official records. Univariate sensitivity analyses were performed (modifying time horizon, cost of treatment continuation and drugs purchase prices) to investigate the impact of varying values of key parameters.

RESULTS: With a 94.1% probability, CladT was dominant over DMF, with lower costs (-81,637 € [95% CI -77,452; -88,549 €]) and greater effectiveness (0.1399 [95% CI - 0.2379; 0.2067] QALY) per patient. Indirect costs, related to losses in productivity, were lower in the CladT arm due to a slower disability progression. In fact, at the end of the 10-year horizon, the % of patients in the health state 4, with higher indirect costs, was 18,2% and 30,2% with CladT and DMF respectively. Patterns of results were consistent in the sensitivity analyses. The difference of 0.1399 QALYs in favour of CladT was clinically relevant which means beneficial to the patient. In the absence of troublesome side effects and excessive cost, this result would recommend a change in the patient's management.

CONCLUSIONS: Management of RRMS patient leads to substantial economic burden on the society, with losses of work productivity that can be up to 61% of the cost of the disease. This analysis shows the dominance of CladT over DMF, suggesting that an earlier use of CladT could be an efficient management strategy that contributes to the sustainability of the National Health System.