Budget impact analysis and treatment availability with biosimilar TNF inhibitors in rheumatic diseases in Poland: real-world evidence using a nationwide database

Abstract

ObjectivesAlthough several years have passed since biologic disease modifying antirheumatic drugs were introduced to the market, considerable disparities in access still remain. Tumour necrosis factor inhibitors (TNFi) have proven to be highly effective and safe for treating patients with rheumatic musculoskeletal diseases (RMDs). The emergence of biosimilars is promising for cost reduction and more equitable, widespread access.MethodsA retrospective budget impact analysis based on final drug prices was conducted using 12 687 treatment courses for infliximab, etanercept and adalimumab. Estimated and real-life savings for public payer were calculated from an 8-year perspective of TNFi use. Data on the treatment cost and on the evolution in the number of patients treated was provided.ResultsFrom a public payer perspective, the estimated total savings amount to over €243 million for TNFi, with over €166 million attributed to treatment cost reduction in RMDs. Real-life savings were calculated as €133 million and €107 million, respectively. The rheumatology sector generated between 68% and 92% of total savings across models, depending on the adopted scenario. The overall decrease in mean annual cost of treatment ranged between 75% and 89% in the study frame. If all budget savings were spent on reimbursement of additional TNFi, a hypothetical total of almost 45 000 patients with RMDs could be treated in 2021.ConclusionsThis is the first nation-level analysis that shows estimated and real-life direct cost-savings for TNFi biosimilars. Transparent criteria for reinvesting savings should be developed on both a local and an international levels.

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

“…The average annual treatment cost with ADA, ETN, or INF in 2021 amounted to 746 EUR, 1963 EUR, and 1159 EUR per patient, respectively. 12 If we considered a scenario in which all these savings were reinvested into the least costly TNFis, more than 3 times more patients could have received treatment.…”

“…14, 15 Despite good assimilation of biosimilars in Poland, access to biologic treatment in rheumatology, but also for other indications, 16 is not satisfactory. In our previous report, 12 we showed that savings associated with access to TNF inhibitor (TNFi) biosimilars did not result in a meaningful increase in the number of patients using these less costly bDMARDs. However, it is unknown whether the generated savings increased access to other innovative drugs within the rheumatology sector whAT's NEw?…”

“…The analysis period covered market availability of INF (from 2014), ETN (from 2016), and ADA (from 2019) biosimilars with evaluation of savings for the public payer in Poland based on the previously described methodology. 12 Data on the total number of patients and the number of patients with RA, PsA, and axSpA (including ankylosing spondylitis [AS] and nonradiographic axial spondyloarthritis [nr -axSpA]) using bDMARDs or JAKis, as well as relevant cost analyses included the years from 2013 to 2022. Detailed treatment analysis for individual drugs was performed between 2016 and 2022.…”

“…To a certain degree, this may be driven by local policy regarding savings reinvestment and resource allocation. 12 Recently, a paradigm shift can be observed regarding the market price of several bDMARDs due to a competition between originators and biosimilar agents. Countries with high market penetration of biosimilars (policy driven) may achieve substantial improvements in drug access through price competition and structured savings reinvestment.…”

“…Total payer expenses covering reimbursement of all therapies, for all indications, are shown for individual years. Real -life savings for the public payer, as described in a previous study, 12 were calculated based on the total annual drug budget during the biosimilar market competition era. Savings of the public payer were calculated for the years 2019-2022 and compared with 2018, when the expenditure reached its peak value.…”