Date of Award

Fall 11-19-2019

Document Type

Thesis

Degree Name

Master of Science (MS)

Department

Pharmaceutical Sciences

First Advisor

Enrique Seoane-Vazquez, PhD

Second Advisor

Rosa Rodriguez-Monguio , PhD

Third Advisor

Lawrence Brown, PharmD, PhD, FAPhA

Fourth Advisor

Jelena Lewis, PharmD, BCACP, Aph

Abstract

INTRODUCTION: Diabetes mellitus is one of the most prevalent and costly chronic diseases in the United States (US). The healthcare and drug cost of diabetes has risen steadily and the increase in patients’ out-of-pocket drug expenditures are associated with a reduction in treatment adherence. The objectives of this study were to assess trends in insulin products prices in the period January 1983-July 2019, and to compare the price, acquisition costs and reimbursement amount of insulins available in the US.

DATA AND METHODS: Data of insulin products marketed in the US during the period January 1983-July 2019 was derived from the FDA databases, the RedBook online, Medicaid.gov, the Department of Veterans Affairs, and the Centers for Medicare & Medicaid Services. Prices were adjusted using the consumer price index (CPI). The compounded average group rate (CAGR) was calculated for each insulin product. Data was analyzed by summary descriptive statistics.

RESULTS: Human insulins had a CPI-adjusted AWP CAGR ranging 4.89%-8.89% from the first AWP effective date to July 2019 and insulin analogues had a CPI-adjusted AWP CAGR ranging 9.5%- 9.75%. The 2 follow-on (biosimilar) insulins; long-acting insulin glargine and rapid-acting insulin lispro experienced a negative adjusted CAGR (-1.20%, -33.70%, respectively). Insulin acquisition cost and reimbursement amounts showed a large variation when compared with the average wholesale (AWP) prices. The wholesale acquisition cost (WAC) was typically set at 83.33% of the AWP. Community pharmacies acquired insulins and analogues at a median of 80.27% of the AWP. Significant reductions in AWP were observed for Medicare Part D (78.80% of the AWP), and Federal Supply Schedule (FSS) /Big4 (25.89%).

CONCLUSION: Manufacturer prices of insulins and analogues increased significantly during the period of 1983- July 2019. There are significant differences in the manufacturer prices, pharmacy acquisition costs and reimbursement rates of insulins and analogues.

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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