Impact of Safety Concerns and Regulatory Changes on the Usage of Erythropoiesis-Stimulating Agents and RBC Transfusions

Abstract

Purpose. Safety concerns raised in the recent oncology trials with erythropoiesis-stimulating agents (ESAs) have led to regulatory restrictions on their use. We wished to determine the impact of these changes on the use of ESAs and RBC transfusions. Conclusions. Recent ESA safety concerns and regulatory restrictions have significantly decreased ESA use. The lack of a significant impact on transfusions may be related to a lower hemoglobin threshold used to initiate ESAs or treatment of patients less likely to respond. The Oncologist

Changes in the use of erythropoiesis‐stimulating agents (ESAs) and red blood cell transfusion in patients with cancer amidst regulatory and reimbursement changes

“…Henry et al showed that the number of ESA administrations per patient decreased from a mean of 4.6 to 2.9 following the NCD, nearly identical to our results. Previous studies have reported a decrease in mean Hb levels and the proportion of patients with Hb > 10 g/dL at the time of treatment initiation, findings that are in agreement with our oncology EMR database results. However, these previous studies examined that smaller study populations and fewer tumor types had shorter follow‐up periods and generally were less geographically representative .…”

“…Our results are consistent with prior studies showing decreases in ESA use and increases in transfusion use following the ESA label change and subsequent NCD. Henry et al showed that the number of ESA administrations per patient decreased from a mean of 4.6 to 2.9 following the NCD, nearly identical to our results.…”

Trends in anemia management in lung and colon cancer patients in the US Department of Veterans Affairs, 2002–2008

“…The declines in ESA use in the VA echo those found in two other cancer populations, at UCLA and affiliated community practices [14] and at the MD Anderson Comprehensive Cancer Center [11,15]. Hess and colleagues [12] found a 26% reduction in ESA use during chemotherapy among patients in 39 sites across 7 states, much smaller than the 66% (colon) and 77% (lung) drops in unadjusted prevalence of ESA use in our sample (not shown).…”

“…A few single-institution and regional studies suggest that ESA use in cancer care has declined in recent years [11][12][13][14][15], but little is known about ways in which clinical decision making has changed in response to the dissemination of study results and practice guidelines, FDA advisories, product labeling changes, and CMS reimbursement restrictions. We examined ESA treatment in cancer care in the U.S. Department of Veterans Affairs Health Care System (VA), where approximately 40,000 patients are diagnosed with cancer each year nationwide.…”

Trends in Anemia Management in Hemodialysis Patients with Cancer

“…12 Two studies of cancer patients treated at MD Anderson Comprehensive Cancer Center reported decreases in ESA use between 2006 and 2008 of 17% to 5% and 4% to 1%. 11,13 …”