Date of Award

2017

Document Type

Open Access Dissertation

Department

College of Pharmacy

Sub-Department

Pharmaceutical Sciences

First Advisor

Kevin Lu

Abstract

Background: Erythropoiesis-stimulating agents (ESAs) are biological drugs used to stimulate the production of red blood cells. ESAs are commonly prescribed for cancer patients with chemotherapy-induced anemia and chronic kidney disease (CKD) patients with low levels of hemoglobin. Due to the increasing safety concerns, Centers for Medicare and Medicaid Services (CMS) issued a Medicare reimbursement policy change for ESAs in cancer patients to regulate the utilization of ESAs. For chemotherapy-induced anemia, when patients had solid tumors, multiple myeloma, lymphoma, or lymphocytic leukemia, ESA treatment is reimbursable by CMS only when the hemoglobin level is < 10g/dL.

Objectives: The objectives of this study were to (1) examine the utilization of ESAs and blood transfusions in cancer patients with chemotherapy-induced anemia before and after the implementation of Medicare reimbursement policy; (2) examine the impact of Medicare reimbursement policy change on the risks of myocardial infarction (MI), stroke, and venous thromboembolism (VTE) in incident users of ESAs with chemotherapy-induced anemia; and (3) examine the impact of Medicare reimbursement policy change on anemia-related and total medical costs in incident users of ESAs with chemotherapy-induced anemia.

Methods: This study used the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database. A repeated cross-sectional design was used in Aim 1 and a retrospective incident user cohort design was used in Aim 2 and 3. The treatment group of the study was composed of Medicare beneficiaries with cancer and the control group of the study was composed of Medicare beneficiaries with CKD. In Aim 1, an interrupted time series design with a control group was used to examine the impact of Medicare reimbursement policy change on the utilization of ESAs and blood transfusions. In Aim 2, a logistic regression model was used to examine the impact of Medicare reimbursement policy change on the risks of MI, stroke, and VTE associated with ESAs. In Aim 3, a difference-in-difference design was used to examine the impact of Medicare reimbursement policy change on anemia-related and total medical costs associated with ESAs.

Results: After the implementation of Medicare reimbursement policy, the level in the monthly utilization of ESAs was reduced by 2.13% (P < .0001) but the trend in the monthly utilization of ESAs remained stable (P = .1366). After the implementation of Medicare reimbursement policy, the level in the monthly utilization of blood transfusions was increased by 0.10% (P = .0186) but the trend in the monthly utilization of blood transfusions remained stable (P = .0524). In the adjusted logistic regression analysis, we found that the implementation of Medicare reimbursement policy was not associated with the future development of MI (OR: 1.01; 95% CI: 0.74-1.39), stroke (OR: 0.99; 95% CI: 0.84-1.15), and VTE (OR: 0.93; 95% CI: 0.84-1.03). In the adjusted generalized linear regression analysis, we found that the implementation of Medicare reimbursement policy was associated with a 11.20% (P = .0113) reduction in anemia-related costs (a 9.83% reduction in Medicare payment (P = .0310) and a 18.40% reduction in patient cost-sharing (P < .0001)), and a 11.96% (P = .0001) reduction in total medical costs (a 11.59% reduction in Medicare payment (P = .0003) and a 13.58% reduction in patient cost-sharing (P < .0001)).

Conclusion: Medicare reimbursement policy had a one-time only effect on the utilization of ESAs and blood transfusions (a relative 50% reduction in the monthly utilization of ESAs and a relative 10% increase in the monthly utilization of blood transfusions). Medicare reimbursement policy change had no impact on the risks of MI, stroke, and VTE associated with ESAs in cancer patients with chemotherapy-induced anemia. Medicare reimbursement policy change had an impact on the anemia-related and total medical costs associated with ESAs in cancer patients with chemotherapy-induced anemia (a 10% reduction in either anemia-related or total medical costs).

Rights

© 2017, Minghui Li

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