OBJECTIVES:To assess the Bulgarian health-insured patients’ access to medicines for MS, examine the trend in public expenditures for reimbursed medicines for multiple sclerosis (MS) in Bulgaria from 2016 to 2019 and predict the future costs.

METHODS: Data on the cost of reimbursed medicines for MS were collected retrospectively from the National Health Insurance Fund (NHIF) for the period 2016-2019. MS medicines were systematized according to ATC code and INN. Reimbursed pharmacotherapy costs were analyzed per year. The expenditures were extrapolated using TREND function for the next 3-year period 2020-2022. Patients access was assessed through analysis of the available medicines for MS in the Positive Drug List (PDL) and officially published pharmacotherapeutic guidelines.

RESULTS: Most of the approved medicines for MS in the European Union are included in the Bulgarian PDL: interferons (interferon beta 1a, interferon beta 1b, peginterferon beta-1a), selective immunosupressants (teriflunomide, fingolimod, natalizumab, alemtuzumab, ocrelizumab, cladribine), other immunostimulants (glatiramer acetate), other immunosuppressants (dimethyl fumarate). Ocrelizumab and alemtuzumab being fully reimbursed from 2019 and 2018, respectively. The total reimbursed pharmacotherapy cost showed an increasing tendency from € 19 369 695.45 in 2016 to € 22 140 640.21 in 2019, respectively. Interferons (53% in 2016 to 37% in 2019) and immunostimulants (22% to 14%) relative share decreases, while immunosupressants increases (25% to 49%).

CONCLUSIONS: Bulgarian patients access to medicines for MS is ensured through adequate financial measures. The pharmacotherapy cost for MS increased in 2016-2019 as the trend is predicted to be the same for the next 3 years.