OBJECTIVES: Multiple sclerosis is a chronic autoimmune disease of the central nervous system, which results in inflammation, axonal transection, and demyelination. The primary objective of this study was to evaluate the budget impact (BI) of the implementation of cladribine tablets as a second line treatment of patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

METHODS: A BI model was prepared to evaluate the economic impact of cladribine tablets for the treatment of RRMS in Bulgaria. For the base case analysis, the model was developed and populated with epidemiologic local data and compares the total budgetary costs of a scenario with cladribine tablets versus a scenario without cladribine tablets. The base case time horizon in the model was 5 years.

RESULTS: Compared to the current second line treatment scenario (alemtuzumab, natalizumab, fingolimod), the inclusion of cladribine tablets in the reimbursement list may yield savings of approximately 3,44 million BGN (Bulgarian Lev) over 5-year time horizon. The sensitivity analysis was consistent with the base case.

CONCLUSIONS: The introduction of cladribine tablets in the Bulgarian NHIF brings significant improvements in the budget impact, with total savings of 3,44 million BGN over the five-year time horizon.