Cost of arthropathic diseases therapy with biologicals disease modifying drugs (bDMARs): a 5-year cost analysis at national level.

This study analysed the changes in the reimbursed cost, prices and utilization of biological medicines for a 5-year time horizon, encompassing three major arthropathic diagnoses, rheumatoid arthritis (RA), psoriatic arthropathies (PsA) and ankylosing spondylitis (AS), from the point of view of the third-party payer in Bulgaria. National; population based; macroeconomic; top-down budget analysis was performed based on official data about the number of inhabitants, reimbursed diagnoses and medicines, reimbursed cost, treated patients, and prices of medicines. The utilization of medicines was calculated in DDD per 1000/inh/day. There was an increase of 41% in the number of patients treated with biological medicines. The reimbursement cost of biologicals increased by 21%; however, the per-patient reimbursement costs per diagnosis fell by 40% due to price decreases. Out of 21 reimbursed diagnoses, we saw a significant difference in prevalence (612 SD in 2016 to 1216 SD in 2020; p < 0.05). RA accounted for 2736 patients in 2016, increasing by 131% to 4662 patients in 2020; AS with 1933 patients in 2016 reached 3196 patients by 2020, and PsA with 1128 patients ranked third with a 75% increase. The cost of therapy of RA was the highest, accounting for appr. 15 mill Euro in 2016. The utilization decreased only for 2 INNs (infliximab and rituximab). All INNs experienced a nearly two-fold increase in their utilization: from 0.5244 to 0.9252 DDD/1000inh/day. The cost analysis shows an important place of biologicals for arthropathic diseases therapy; introduction of biosimilars leads to prices and cost decreases. [ABSTRACT FROM AUTHOR]