Access to Innovative Drugs Increases Through Biosimilars Adoption

In a Polish-based study, the savings generated from biosimilars have primarily contributed to enhancing the availability of higher-priced innovative drugs. To optimize resource allocation based on data insights and foster access to affordable biologics, investigators encourage the adoption of dedicated policy solutions, according to research published in Polish Archives of Internal Medicine.¹

Rheumatic musculoskeletal diseases have proven to be a challenge in regard to healthcare and socioeconomic factors. However, the introduction of effective biological drugs has led to a significant reduction of inflammatory symptoms and helped to limit disease progression.²

“In our previous report, we showed that savings associated with access to TNF biosimilars do not result in a meaningful increase in the number of patients using these less costly biologic disease-modifying antirheumatic drugs (bDMARDs),” wrote Marcin Stajszczyk, MD, PhD, Department of Rheumatology and Autoimmune Diseases, Silesian Center for Rheumatology, Orthopedics and Rehabilitation, Ustroń, Poland, and colleagues. “However, it is unknown whether the generated savings increased access to other innovative drugs within the rheumatology sector or had no relevant impact on the biologics and Janus kinase (JAK) availability in rheumatology at all.”

A retrospective analysis using information from a nationwide public payer database was performed to evaluated bDMARDs and JAKs among patients with rheumatic musculoskeletal diseases within a 10-year period in Poland.

In 2022, 11,102 patients with rheumatoid arthritis (RA), 6602 patients with psoriatic arthritis (PsA), and 4400 patients with axial spondyloarthritis (axSpA) received bDMARDs and JAKs.

The most commonly prescribed drug was adalimumab, followed by etanercept and tocilizumab. During the 10-year period, estimated access to innovative drugs increased from .8% to 3.2% in the RA group, 1.4% to 8.7% in the PsA group, and .8% to 3.5% in patients with axSpA. According to results, more affordable TNFs are still predominant among innovative treatments, although a decline in market share was observed (87% to 46%).

Increases in the number of patients treated with other bDMARDs and JAKs almost doubled during the 10-year period. Additionally, average annual treatment costs per patient were shown to reduce by 60%, decreasing from €7315 to €2886. Although JAK inhibitors have received attention for potential safety issues, these drugs have been increasingly utilized in the Polish population.

Additional data related to the COVID-19 pandemic demonstrated limited access to intravenous treatment, although this trend was not seen in subcutaneous or oral formulations.

Investigators noted limitations including potential inaccuracies of the data in the National Health Fund (NHF) records. Additionally, the calculations were predicated on several assumptions, including a static number of patients with rheumatic diseases. However, when assessing count and frequency data, they were unable to determine variation in this population over time. Based on information from the Global Burden of Disease study, small increases in both incidence (8.2%) and prevalence (7.4%) were observed in RA on a global scale between 1990 and 2017. However, as this was a 10-year timeframe, variations in the population level of patients with rheumatic and musculoskeletal diseases were unlikely to significantly change.

“Policy should be driven to enhance the total number of bDMARD users through appropriate incentivizing, with reinvestment into reimbursement of less costly and other innovative agents at least to the same extent,” investigators concluded. “Lessons from Poland can help other countries that are at an earlier stage of biosimilars entrance for effective solutions implementation to take full advantage of their access.”

References

1. ^{Stajszczyk M, Kwiatkowska B, Żuber ZM, Batko B. Access to biologics and JAK inhibitors for the treatment of rheumatic diseases in the biosimilars era in Poland: nation-level study. Pol Arch Intern Med. Published online January 2, 2024. doi:10.20452/pamw.16655}
2. ^{Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Annals of the Rheumatic Diseases. 2023; 82: 3-18.}