The American Association of Kidney Patients (AAKP) and Renal Physicians Association (RPA) contacted members of Congress to express our mutual concerns regarding the impact of policy decisions made by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) affecting use of Erythropoiesis Stimulating Agents (ESAs). ESAs are used to treat anemia in adults with end stage renal disease (ESRD). Our organizations believe that the June 2011 FDA label change for ESAs, combined with the subsequent decision later that month by CMS to retire the lower hemoglobin measure as part of the 2012 ESRD Quality Incentive Program (QIP), have already had a substantively negative impact overall on the health of the nation’s ESRD patients and if the current policy prevails, their health will continue to deteriorate further.
Specifically, there is now data from the United States Renal Data System (USRDS) indicating a significant increase in the number of ESRD patients receiving blood transfusions since the time of the policy revisions, and we believe that the FDA label change and CMS decision to retire the lower hemoglobin measure were the catalysts for this increase.
AAKP and RPA share the FDA’s concerns regarding patient safety associated with ESA prescriptions that result in high hemoglobin (Hb) levels or very high ESA doses. Accordingly, we recognize that the studies raising substantial unease about the safety of ESAs when they are used to raise Hb concentrations to the normal or near normal Hb range of 13 grams or greater per deciliter (Gm/dL) for extended periods must be heeded. With the condition that a target Hb should not be targeted to 13 or higher, AAKP and RPA believe that nephrologists and patients should be free to determine for each individual patient the best use of ESAs. It is our opinion that individuals’ quality of life, as measured by patient reported outcome measures, should be used in determining individual prescriptions, and that more research is needed before arbitrary policy decisions are made regarding the goals of anemia treatment.
Acknowledging those points, it is also our belief that as a result of other policy changes affecting ESA use, most nephrologists had already been reducing doses for ESAs at or around Hb 11 g/dL, which would address the thrust of the FDA labeling to minimize the risks shown at higher Hb levels. AAKP and RPA are now concerned that the label change and ensuing CMS policy revision has caused the policy pendulum to swing too far in the opposite direction, with the potential harm of causing persistent, severe, or transfusion-dependent anemia in patients at lower hemoglobin levels.
In fact, in May of 2012 the United States Renal Data System released data indicating that in a corresponding month comparison over the first nine months of 2010 and 2011, the percentage of patients receiving blood transfusions increased between 9 and 22 percent. This is significant because blood transfusions given to patients awaiting transplantation may reduce the likelihood that these patients will ever receive transplanted kidneys, as transfusions often produce sensitization that reduces the possible donor matches for transplantation. Patients with sensitization have longer waiting times pre-transplant (negatively affecting organ transplant survival), and lower graft survival post-transplant. It is therefore critically important to prevent avoidable blood transfusions whenever possible.
Transplantation offers patients with kidney failure the best quality of life when compared with lifelong dialysis treatment. AAKP and RPA are concerned that an overly restrictive ESA policy revision that does not account for the need to minimize the use of transfusions will have an unintended and unnecessarily detrimental impact on transplant recipient waiting lists and organ survival. Fortunately, since ESAs became widely available in 1989, blood transfusions in outpatient hemodialysis patients have significantly decreased. We urge Congress to support policies that preserve this advancement in kidney care.
AAKP and RPA urge members of Congress to contact FDA to direct it to revisit its ESA relabeling decision, and to contact CMS and direct the Agency to seriously reconsider its decision to retire the lower hemoglobin measure in the ESRD QIP program.