NN&I - April 2010
Patient Management 32 Nephrology News & Issues April 2010www.nephronline.com primary consideration in the hemodi -alysis setting because these agents are associated with potential health risks. Several randomized, controlled studies have pointed to an association between ESAs and all-cause and cardiovascular mortality when ESAs are used at high doses in an attempt to reach higher target Hb (e.g., 13 g/dL to 14 g/dL) or Hct (e.g., >42%) levels.30-33 The adverse health risks appear not to be related to the higher Hb/Hct ranges themselves, but to the overuse of ESAs in pursuit of these higher targets. As a result of these studies, there is a warning in the labeling for all ESAs indicating that these agents should be used to achieve a target Hb level between 10 to 12 g/dL, thus placing the lower Hb limit below the KDOQI-recommended Hb of 11 g/dL.9,34-36Although the mechanisms underly-ing ESA-related morbidity are not fully understood, it has been postulated that ESAs, in the presence of iron depletion or marginally sufficient iron, may con-tribute to the development of throm -bocytosis37 and may increase the levels of the proinflammatory cytokine tumor necrosis factor- (TNF-).38 In contrast, patients given IV iron in conjunction with ESAs may have reduced levels of TNF- and lower levels of total peroxide (a marker of free radical concentration), as well as increased levels of the anti-inflammatory cytokine interleukin 4.39Finally, a number of studies in addi-tion to DRIVE have documented signifi -cant cost savings with reduced usage of ESAs.8,23,29,40 These findings take on par -ticular relevance in light of the burgeon-ing costs associated with ESA usage. According to 1996 estimates, ESA use accounted for approximately 25% of the $8.1 billion of annual Medicare hemo-dialysis-related costs in that year.41 The current Medicare payment scheme pro -vides a strong incentive for overuse of ESAs by hemodialysis facilities because ESAs and other drugs are reimbursed separately from the bundled payment for other hemodialysis services.Medicare has taken steps to rein in ESA-associated costs, including reduced reimbursement for patients whose Hct levels exceed 39% over a three-month period. The most far-reaching set of changes, however, comes with a new reimbursement system that will com -bine reimbursement for the dialysis procedure, ESAs, iron, other drugs such as antibiotics and vitamin D analogs, and associated laboratory tests into a single case-mix adjusted bundled com-posite rate. This change is specified in legislation passed by Congress in 2008, and the new bundled reimbursement Figure 3A. Estimated proportion of maintenance hemodialysis patients surviving, stratified by ESA dose and serum ferritin level. Although the differences were small, survival was best in those receiving a low ESA dose (L=\03712.1\327103 units per week), slightly worse in those receiving a medium ESA dose (M = 12.1-27.7\327103 units per week), and worst in those receiving a high ESA dose (H = >27.7\327103 units per week). Reprinted with permission from Pollack, 2009.15 Survival T ime (Days)Median ESA Administered (1000 units/week)Proportion of Patients SurvivingFigure 3A1.00 500ESA H (>27.7) ESA L (\03712.1) ESA M (12.1 - 27.7)1000 1500 .75 .25 .50 0 0 2000 2500 Patient Management_0410_7.indd 32 3/18/10 3:47:25 PM
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