Date of Award

Spring 5-2024

Document Type

Dissertation

Degree Name

Doctor of Philosophy (PhD)

Department

Pharmaceutical Sciences

First Advisor

Enrique Seoane-Vazquez, PhD

Second Advisor

Lawrence Brown, PharmD, PhD, FAPhA

Third Advisor

Rosa Rodriguez-Monguio, PhD, MS

Fourth Advisor

Marc L. Fleming, PhD, MPH, FAPhA

Abstract

Introduction: RA treatment has been revolutionized by the development and approval of biologic disease-modifying antirheumatic drugs (bDMARDs). However, the approval status, utilization, and high cost of bDMARDs pose challenges in RA management.

Objectives: This dissertation evaluated the association between the utilization of bDMARDs and the sociodemographic characteristics of the RA patient population. It also identified the FDA approval status of bDMARDs and assessed the annual cost of bDMARDs used in RA treatment, evaluated the factors explaining annual cost at market entry.

Methods: In the retrospective analysis of Medical Expenditure Panel Survey (MEPS) data from 2010-2021, the population includes RA patients diagnosed using International Classification of Disease (ICD-9 and ICD-10). We used descriptive statistics, chi-square test, and logistic regression. Regulatory information and wholesale acquisition cost (WAC) for bDMARDs were extracted from the FDA and Micromedex. The bDMARD annual treatment cost was estimated using WAC prices at market entry and the FDA recommended dose. We standardized costs to evaluate trends within each group.

Results: We found that 5.2% of RA patients used bDMARDs from 2010-2021 in the MEPS sample. bDMARDs utilization was significantly associated with age, insurance coverage, and education level. While younger patients with private insurance and higher education were more likely to use bDMARDs therapy, factors such as sex, race, marital status, and employment status do not significantly influence treatment choices.

As of December 31, 2023, the FDA had approved ten bDMARDs for RA treatment in US, five of which were in the TNFi classification, and authorized 19 biosimilars for five bDMARDs. After standardization, the trend revealed a significant increase in the costs of TNFi bDMARDs and a substantial decrease following FDA authorization of biosimilars for infliximab, rituximab, and adalimumab. The annual cost at market entry was significantly positively correlated with FDA approval dates and TNFi classification.

Conclusions: The multifaceted nature of biologic therapy in RA management emphasizes the importance of comprehensively understanding the interplay between approvals, utilization, and cost to enhance treatment outcomes and healthcare delivery. Therefore, addressing these factors is important to ensure that all individuals with RA can benefit from these transformative therapies.

Creative Commons License

Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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