People using assistive technology may not be able to fully access information in these files. For additional assistance, please contact us.

Note: This report is greater than 5 years old. Findings may be used for research purposes but should not be considered current.

This report is from AHRQ's Data Points Publication Series.

Overview

The findings described herein were presented by Thomas MaCurdy, Ph.D., at the Medicare Evidence Development & Coverage Advisory Committee meeting held on March 24, 2010, in Baltimore, Maryland.

Chronic renal disease affects more than 26 million Americans and is the cause of significant morbidity, hospitalization, and mortality. Anemia, a common complication, conveys significant risk for cardiovascular disease, faster progression of renal failure, and decreased quality of life. In fact, most patients with chronic renal disease become anemic. Correction of anemia in such patients is associated with improved outcomes, such as forestalling target organ damage.

Erythropoiesis-stimulating agents (ESAs) are recombinant hematopoietic drugs that stimulate the production of red blood cells. Epoetin alfa received Food and Drug Administration (FDA) approval in 1989, with darbepoetin alfa following in 2001. Thereby, modalities became available for the treatment of anemia in chronic renal failure, chemotherapy-treated cancer, and zidovudine-treated HIV-infected patients. Furthermore, ESAs have allowed the reduction of allogeneic blood transfusions in surgery patients. ESA dosing is individualized to achieve and maintain hemoglobin levels within the range of 10 to 12 grams per dL.5 A number of published studies, beginning in the late 1990s, suggested potential adverse cardiovascular outcomes arising from ESA therapy. Studies amassing over the past decade have led to a number of clinical and policy changes regarding the use of ESAs.

The goal of this Data Points brief was to examine practice trends in the use of ESAs among Medicare beneficiaries with kidney disease (KD) and to relate these trends to the timing of clinical practice and policy events that had the potential to affect ESA use. Secondarily, we examined the use of ESAs in a subpopulation of beneficiaries with KD and cancer.

The work described herein was commissioned for presentation at the March 24, 2010, Medicare Evidence Development & Coverage Advisory Committee meeting to discuss ESAs in anemia related to KD. Additional information on this meeting, including the agenda, presentations, and meeting minutes, can be found at: www.cms.gov/FACA/02_MEDCAC.asp