The use of biosimilars of tumor necrosis factor (TNF) inhibitors within Poland’s public payer saved over €243 million from 2013 to 2021, with about 68% of that coming from the rheumatic musculoskeletal diseases alone.
A retrospective budget analysis from Poland found that use of anti-tumor necrosis factor (TNF) biosimilars within the country’s public payer saved over €243 million between 2013 to 2021, with more than half of those savings coming from rheumatic musculoskeletal diseases (RMDs) alone.
The study, published in Annals of the Rheumatic Diseases, sought to provide real-world evidence using a nationwide database to assess the potential cost savings for Poland’s public payer and to compare the efficacy and safety of biosimilars with their reference products.
Several infliximab, etanercept, and adalimumab biosimilars have been approved in the European Union (n = 4, 3, 10, respectively). However, biosimilar uptake and subsequent savings are often held back due to lack of awareness about biosimilars and doubts over bioequivalence between biosimilars and originators among providers and patients in some health care systems and countries new to biosimilars.
Poland has a well-established reimbursement system that stimulates competition through local tenders, where 1 or more products—biosimilars or reference drugs—are selected to be covered by the public health plan. Tender systems are popular in Europe and result in biosimilar price reductions and reference drug repricing. Additionally, the vast majority of health care in Poland is financed by the National Health Fund (NHF), which publishes data on the national-level effect biosimilar market introductions have on payer budgets.
“Our findings illustrate the extent of real-life (in contrast to the expected) patient-level benefits in an [low- and middle-income] country, and demonstrate how a reductive fiscal policy (with stringent reimbursement and restrictive prescription) constricts biologic accessibility,” the authors wrote.
The researchers conducted a retrospective budget impact analysis using final drug prices and data from 12,687 treatment courses for infliximab (n = 2428), etanercept (n = 3613), and adalimumab (n = 6636). The analysis estimated and calculated real-life savings for the public payer over an 8-year period of TNF inhibitor use. The study also included data on the cost of treatment and the changes in the number of patients treated over time.
From the data, researchers calculated the total value for all patients who are reimbursed for TNF inhibitors, which included patients with various conditions such as RMDs (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondylarthritis, juvenile idiopathic arthritis) and inflammatory bowel diseases (Crohn disease, ulcerative colitis, and psoriasis).
The study found the introduction of biosimilar TNF inhibitors in the treatment of rheumatic diseases in Poland led to significant cost savings for the public payer across 2 scenarios. In the first scenario (basic scenario), where it was assumed that there was an increase in the number of patients treated during the biosimilar reimbursement period, the savings amounted to €243.083 million, with €166.711 million attributed to treatment cost reduction in RMDs.
In the second scenario (alternative scenario), where it was assumed that there was no increase in the number of patients treated during the biosimilar reimbursement period, the overall savings were €133.447 million, with €107.175 million attributed to treating RMDs. The treatment of RMDs accounted for over 68% of total savings in the basic scenario and up to 92% in the alternative scenario.
The mean annual cost of treatment decreased significantly, ranging between 75% and 89% in the study frame. However, the savings were not fully reinvested in additional TNF inhibitor treatments, which limited the increase in treatment availability. If all the budget savings resulting from the introduction of biosimilar TNF inhibitors were spent on reimbursement of additional TNF inhibitors, almost 45,000 extra patients with RMDs could have received treatment in 2021.
Regarding limitations, the study may be limited by hypothetical inconsistencies in the data published by the public payer, and the findings may not be generalizable to other countries due to differences in health care systems and policies.
The authors concluded with advice for the NHF, “If no systemic changes towards a patient-centric health care model are undertaken, we can expect only a modest yearly increase in biologic drug access, for which the observed rate of change is still likely driven by low starting drug availability."
Stajszczyk M, Obarska I, Jeka S, Batko B. Budget impact analysis and treatment availability with biosimilar TNF inhibitors in rheumatic diseases in Poland: real-world evidence using a nationwide database. Ann Rheum Dis. 2023;82(9):1171-1180. doi:10.1136/ard-2022-223696