OBJECTIVES to assess the cost-effectiveness of incorporating cladribine tablets as first line therapy compared to alternative disease-modifying drugs (DMD) in the treatment of patients with high disease activity relapsing-remitting multiple sclerosis, from the social security perspective in Argentina.

METHODS A Markov model provided by Merck and developed by PAREXEL Access Consulting was adapted. It included 11 health states; 10 represented the Kurtzke’s Expanded Disability Status Scale (EDSS) states and one aditional state representing all-cause mortality. Alemtuzumab, dimethyl fumarate, fingolimod, natalizumab and ocrelizumab were incorporated as DMD comparators. Quality- adjusted life- years was used as health outcome. The clinical and epidemiological parameters were obtained through comprehensive bibliographic searches and the consensus of a group of expert neurologists using the modified Delphi technique. The costs were expressed in United States dollars (USD), 2018. For the base case a discount rate of 5% and a life time horizont were considered.

RESULTS Cladribine tablets resulted in a less expensive and more effective strategy compared to dimethyl fumarate, fingolimod, natalizumab and ocrelizumab. Compared to alemtuzumab, cladribine was less expensive (USD 740,055 versus 749,225) although slightly less effective (8.95 versus 9,005 QALYs). The results of the net health benefit indicate that cladribine is cost-effective in relation to all comparators at a threshold of 1 Gross Domestic Product (GDP) per capita of 2018 per QALY gained, with a net incremental health benefit (in QALYs) with respect to alemtuzumab of 0.63. Both deterministic and probabilistic sensitivity analysis showed robust results.

CONCLUSIONS Cladribine tablets is a cost-efective therapy compared to other available DMD for the treatment of high disease activity relapsing-remitting multiple sclerosis from the social security perspective in Argentina.