Study Demonstrates Potential Cost Savings of TNF Inhibitor Biosimilars

A nation-wide Polish analysis of the estimated and real-life direct cost-savings for tumor necrosis factor (TNF) inhibitor biosimilars emphasized the need for transparent criteria for reinvesting savings on both a local and international level, according to research published in Annals of the Rheumatic Diseases.¹

Biologic disease-modifying antirheumatic drugs (bDMARDs), including TNF, are a mainstay treatment modality for several rheumatic musculoskeletal diseases. Although these drugs are considered safe and effective options for the treatment of these conditions, their high price point limits the availability for many patients, particularly for those in lower- and middle-income (LAMI) countries, like Poland, Romania, and Hungary. Therefore, the availability of biosimilars may increase access and generate savings due to on-market competition and the renegotiation of bio-originator drug prices.²

“Both disease activity and bDMARD use are associated with socioeconomic factors, drug affordability, and reimbursement stringency,” wrote Marcin Stajszczyk. MD, PhD, Head of the Department of Rheumatology and Autoimmune Diseases, Silesian Center for Rheumatology, Ustroń, Poland, and colleagues. “Across Europe, considerable disparities in bDMARD access and eligibility are prevalent.”

To examine the impact of the TNF biosimilars on the public payer budget and assess the availability of TNFs, investigators conducted a retrospective budget impact analysis of drug prices using 12,687 treatment courses for adalimumab, etanercept, and infliximab.

Data from an 8-year perspective of TNF therapy was used to determine estimated (a measure based on “pre-biosimilar” prices and “post-biosimilar” volume) and real-life savings for the payer. Additional data on the number of patients treated and treatment cost were collected from the National Health Fund (NHF). The total value for all patients who had their TNF reimbursed was calculated, and included patients with rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, inflammatory bowel diseases, and psoriasis.

Of the 12,687 patients, 6636 received adalimumab, 3613 received etanercept, and 2438 received infliximab. Results revealed from a public payer perspective, the estimated total savings was over €243 million for TNF, with over €166 million ascribed to reductions in treatment costs for rheumatic diseases. The real-life savings were €133 million for TNF, with €107 million attributed to reductions in treatment costs for rheumatic diseases.

The rheumatology section produced between 68% and 92% of total savings across models and the overall decrease in the mean annual cost of treatment was between 75% and 89%.

Overall access to TNF therapy had a slight increase after the introduction of biosimilars, which was consistent across both outcome measures. Investigators estimated a total of approximately 45,000 patients with rheumatic musculoskeletal diseases could have been treated in 2021 if all budget savings were spent on the reimbursement of additional TNF.

Investigators noted a strength of the study was the ability to produce an exact calculation based on the public payer’s data as well as the evaluation of the rheumatology-specific contribution to the total results. However, the analysis may have been limited by the potential inconsistency of data published by the payer. Treatment costs and availability were estimated using 2 different approaches to analyze discrepancies across NHF records. Investigators emphasized the share of rheumatology in total savings will vary across individual countries depending on the number of patients treated for each indication.

“Biosimilar-related reduction in TNF prices mainly led to reduced expenditure within the rheumatic musculoskeletal disease sector of Polish healthcare,” investigators concluded. “Our findings illustrate the extent of real-life (in contrast to the expected) patient-level benefits in a LAMI country and demonstrate how a reductive fiscal policy (with stringent reimbursement and restrictive prescription) constricts biologic accessibility.”

References

1. ^{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 [published online ahead of print, 2023 Jun 16]. Ann Rheum Dis. 2023;ard-2022-223696. doi:10.1136/ard-2022-223696}
2. ^{Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial Spondyloarthritis: 2022 update. Ann Rheum Dis 2023;82:19–34. doi:10.1136/ard-2022-223296}