OBJECTIVES: The study evaluated the percentage price change since market entry (ME) and drug cost of approved timDMARDs in the United States, assessed price trends per unit dose over the years and investigated factors influencing ME prices.

METHODS: The study collected average wholesale prices (AWP) per unit dose of timDMARDs from ME to the last effective dates from the Red Book and estimated their aggregate percentage increase and the compound annual growth rate (CAGR). The AWPs per unit dose were computed and used to calculate the drug cost of therapy per recommended monthly dose (RMD). Trends in AWPs per unit dose were also graphically evaluated according to their classifications. Furthermore, correlation and linear regression were performed to identify regulatory factors significantly associated with AWPs at ME.

RESULTS: All timDMARDs’ AWP per unit dose increased significantly over time, with adalimumab, certolizumab, etanercept, golimumab, anakinra, and tofacitinib experiencing the highest aggregate percentage increase (106.5%-286.1%). Etanercept had the highest CAGR of 9.9%, followed by golimumab (8.9%), while baricitinib (1.8%) and upadacitinib (1.7%) had the lowest. The drug cost of therapy per RMD for rituximab and golimumab were $20,188.50 and $14,160.50, respectively, compared to sarilumab ($4,337.00) and baricitinib ($3,164.10). Newer timDMARDs entered the market at higher prices compared to previous timDMARDs and caused competitive price increase over the years. However, only application type (P = 0.04) showed a significant association with AWPs at ME despite moderate correlations with the route of administration, orphan designation, classification type, and approval review type.

CONCLUSIONS: The study revealed that timDMARD prices at ME have increased over time, with bDMARDs having the highest CAGR. Newer timDMARDs’ prices may induce an increase in older timDMARDs’ prices. The study highlighted the importance of promoting sponsorship for non-biologics and biosimilars to reduce the financial burden on patients and healthcare payers and promote timDMARD utilization.