Abstract

BackgroundVariation in de-adoption of ineffective or unsafe treatments is not well-understood. We examined de-adoption of erythropoiesis-stimulating agents (ESA) in anemia treatment among patients with chronic kidney disease (CKD) following new clinical evidence of harm and ineffectiveness (the TREAT trial) and the FDA’s revision of its safety warning.MethodWe used a segmented regression approach to estimate changes in use of epoetin alfa (EPO) and darbepoetin alfa (DPO) in the commercial, Medicare Advantage (MA) and Medicare fee-for-service (FFS) populations. We also examined how changes in both trends and levels of use were associated with physicians’ characteristics.ResultsUse of DPO and EPO declined over the study period. There were no consistent changes in DPO trend across insurance groups, but the level of DPO use decreased right after the FDA revision in all groups. The decline in EPO use trend was faster after the TREAT trial for all groups. Nephrologists were largely more responsive to evidence than primary care physicians. Differences by physician’s gender, and age were not consistent across insurance populations and types of ESA.ConclusionsPhysician specialty has a dominant role in prescribing decision, and that specializations with higher use of treatment (nephrologists) were more responsive to new evidence of unsafety and ineffectiveness.

Highlights

  • Variation in de-adoption of ineffective or unsafe treatments is not well-understood

  • There were no consistent changes in darbepoetin alfa (DPO) trend across insurance groups, but the level of DPO use decreased right after the Food and Drug Administration (FDA) revision in all groups

  • The decline in epoetin alfa (EPO) use trend was faster after the to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) trial for all groups

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Summary

Introduction

We examined deadoption of erythropoiesis-stimulating agents (ESA) in anemia treatment among patients with chronic kidney disease (CKD) following new clinical evidence of harm and ineffectiveness (the TREAT trial) and the FDA’s revision of its safety warning. Anemia is common among patients with chronic kidney disease (CKD), and erythropoiesis-stimulating agents (ESA) are commonly used to stimulate bone marrow to produce red blood cells, improving anemia symptoms and preventing the need for blood transfusion [1]. The main types of ESA in the U.S are epoetin alfa (EPO) [1] and darbepoetin alfa (DPO) [3], which mainly differ in how frequently the drug is administered to patients [2]. The use of ESA therapy for anemia in CKD patients is common in many countries – Wong et al [7] estimated that 48% patients with a hemoglobin level < 10 g/dL in the US, 58% in Brazil, 66% in France, and 70% in Germany were prescribed an ESA or iron in the 3

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