Access to biologics and JAK inhibitors for the treatment of rheumatic diseases in the biosimilars era in Poland: nation-level study.

By reducing treatment costs, biosimilars represents an opportunity for improved accessibility to highly effective drugs. This study aimed to assess access to the biologic antirheumatic drugs (bDMARDs) and janus kinase inhibitors (JAKis) among patients with rheumatic musculoskeletal diseases within a ten year timeframe in Poland. A retrospective analysis using a nationwide public payer database was done. By 2022, 11,102, 6,602 and  4,400 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) were treated with bDMARDs/JAKis, respectively. Peak drug utilization was observed for adalimumab followed by etanercept and tocilizumab. Within the study timeframe, the estimated access to innovative drugs increased to 3.2%, 8.7% and 3.5% from the previous 0.8%, 1.4% and 0.8%, among RA, PsA and axSpA patients, respectively. Affordable TNF inhibitors (TNFis) are still predominant among innovative therapeutics, but a market share decline from 87% to 46% was observed. Respective to less costly TNFis, the increase in the number of patients treated with other bDMARDs/JAKis, was almost doubled within the prespecified timeframe. Overall, the average annual treatment cost per patient decreased by 60%, from the €7,315 to €2,886. Despite the recent safety warnings, JAKis appear to be increasingly utilized. Additional analyses regarding COVID-19 pandemic showed impaired access to intravenous therapies, but not subcutaneous or oral formulations. In Poland, biosimilars-related savings contributed more so to improvement of higher priced innovative drugs availability, rather than less costly TNFis. Data-driven resource allocation and dedicated policy solutions facilitating access to affordable biologics are recommended.