No Adverse Outcomes Following Bundling
Action taken to mitigate risks associated with ESA use and changes in payment policy did not result in a relative increase in death or major cardiovascular events.
Two studies published in 2016 showed that the risks of adverse cardiovascular events and death among dialysis patients did not increase after the January 1, 2011 debut of the federal government's prospective payment system for dialysis care (“bundling”) and, about 6 months later, revision of FDA drug labeling for erythropoiesis-stimulating agents (ESAs).
The modified drug labels for epoetin alfa and darbepoetin alfa advised against the use of ESAs in patients with end-stage renal disease and hemoglobin levels of 11 g/dL or higher.
In a study of 69,718 incident hemodialysis (HD) patients aged 66 years or older, Cunlin Wang, MD, PhD, of the FDA's Center for Drug Evaluation and Research in Silver Spring, Maryland, and colleagues found that, compared with patients who started HD before bundling, those who started HD after bundling had similar risks for major adverse cardiovascular events (MACE), death, venous thromboembolism (VTE), and hospitalization for congestive heart failure and a significant 23% lower risk of stroke. The researchers published their findings in JAMA Internal Medicine (2016;176:1818-1825).
In the other study, Glenn M. Chertow, MD, of Stanford University in Palo Alto, California, and colleagues also found that bundling and the FDA ESA label changes did not result in a relative increase in MACE or death.
The investigators examined data from annual cohorts of dialysis patients from 2005 to 2012. Observed rates of all-cause mortality, cardiovascular mortality, and myocardial infarction in 2011 and 2012 were consistent with expected rates, Dr. Chertow's group reported in the Journal of the American Society of Nephrology (2016;27:3129-3131). Results showed lower-than-expected observed rates of stroke, venous thromboembolic disease, and heart failure in 2012. In addition, during 2012, observed rates of stroke, VTE, and heart failure were lower than expected.
“This initial evidence suggests that action taken to mitigate risks associated with ESA use and changes in payment policy did not result in a relative increase in death or major cardiovascular events and may reflect improvements in stroke, VTE, and heart failure,” Dr. Chertow and his colleagues concluded.