OBJECTIVES: To determine the budgetary impact of the incorporation of cladribine tablets as a first-line disease modifying drug (DMD) in recurrent high disease activity remitting multiple sclerosis from the perspective of social security in Argentina.

METHODS: A budget impact model provided by Merck and developed by PAREXEL Access consulting was adapted for a hypothetical healthcare payer with a population of 1,000,000 subjects covered at five years. The model included four main components: 1) the estimation of the eligible population, 2) the DMD market share (cladribine, alemtuzumab, dimethyl fumarate, fingolimod, natalizumab and ocrelizumab), 3) the costs related to the acquisition, administration and monitoring of DMD; and 4) costs associated with relapse, management of adverse events and rescue therapy. The clinical and epidemiological parameters of the model were obtained through comprehensive bibliographic searches and a modified Delphi technique, which included local neurologists. The costs were expressed in United States dollars (USD), 2018.

RESULTS: The net budgetary impact of the incorporation of cladribine for the treatment of high disease activity remitting multiple sclerosis implied a net saving for the healthcare payer of USD 346,352 accumulated over five years. This represented a saving of 2.3% in relation to the total budget for the management of high disease activity remitting multiple sclerosis, considering a scenario of partial displacement of the indication of alemtuzumab by cladribine. In additional scenarios, which assumed the total displacement of alemtuzumab by cladribine and the non-displacement between drugs, the accumulated net savings for the healthcare payer ranged between 1.1% and 3.8%, respectively.

CONCLUSIONS: The incorporation of cladribine tablets for the treatment of patients with high disease activity remitting multiple sclerosis is associated with a net accumulated saving in the budget of a social security financier of Argentina.