OBJECTIVES: To estimate the clinical and economic benefits of using cladribine tablets in patients with RRMS in the institutions of the Public Health System in Mexico.

METHODS: A systematic literature review was conducted in Medline/PubMed, Cochrane Library, and LILACS. Costs and efficacy of cladribine tablets were compared with fingolimod, alemtuzumab, ocrelizumab, natalizumab, and ofatumumab. Cost-minimization analysis (CMA) and budget impact analysis (BIA) were performed from the perspective of public health institutions in Mexico, considering direct medical costs such as drug acquisition, administration, patient monitoring, prophylaxis, and costs associated with loss of response.

RESULTS: Cladribine tablets reduced the annualized relapse rate by 58% in the CLARITY study and by 47% in the CLASSIC-MS study, with a 33% reduction in confirmed disability progression in the CLARITY Extension study. Additionally, 55.8% of patients initially treated with cladribine tablets had not received another DMT in an average of 10.9 years. Long-term use decreased disease activity for over 4 years with a good safety profile. The total treatment cost with cladribine tablets over 10 years was $986,042.61, representing an average savings of 45.15% compared to the other alternatives. The ten-year budget impact was $71,535,994, equivalent to 0.0705% of the medication budget.

CONCLUSIONS: Cladribine tablets are a safe and effective alternative for RRMS, providing significant savings and improving treatment adherence due to simplified administration. This allows public health institutions to offer effective and economical treatments to patients with RRMS.