NN&I - May 2010
8 Nephrology News & Issues May 2010www.nephronline.com Mr. Neumann has been editor of Nephrology News & Issues since 1989.FIRST WORDBy Mark E. Neumanninformation for a possible National Coverage Decision (NCD) on ESA use, it was clear that committee chairman Clifford Goodman, senior vice president of the Lewin Group, was looking for some clues. In a question to the panelists, he asked, "Where are the greatest evidence gaps you see if we were to create a National Coverage Decision" for use of ESAs among CKD patients? Recently, the FDA got tougher on the use of ESAs to treat anemia in cancer patients. The agency has required Amgen Inc. to establish a risk management program for the use of Aranesp, based on studies that found that ESAs caused tumors to grow faster and resulted in ear -lier deaths in some cancer patients. The company's APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program requires health care professionals who treat patients with cancer to do the following: Register and maintain enrollment \037 in the ESA APPRISE program Complete a training module on \037 how to use ESAs in cancer patients Discuss the risks, benefits, and \037 approved uses of ESAs with patients before beginning a course of ESA treatment, and document this dis -cussion with the patient. That sounds reasonable and cer -tainly applicable for use of ESAs in any setting. As Dori Schatell argues in our "Viewpoint" section this month (see page 14), patients should be educated on the risks and benefits of ESAs so they can make their own decisions about using them.The debateThe committee made an attempt to line up both advocates and detrac-tors on the ESA question. Several patients testified about what life was like before ESAs (one patient said ane -mia made her feel like "a bag of dirt"). Clinicians spoke about the concern over the impact of using higher doses to achieve hemoglobin targets; oth-ers suggested separating the science to determine if it is the dosage of the drugnot the hemoglobin range that was creating the risk. Nephrologists Fred Finkelstein and J. Michael Lazarus said the improve-ments in quality of life with ESAs are significant. "I practiced nephrology for 20 years before ESAs," Lazarus said. "I cannot fathom going back to those days again." After hearing the testimony, Goodman and the committee said a lack of good clinical trials prevent -ed development of an NCD for now. "There is too great a gap in what we observe in practice" and what we know from clinical trials, he said. "In the long run I don't believe that is tolerable." The key is to find the best possible hemoglobin range, achieved with the lowest possible dose. Let's find some answerssoon.* Cardiovascular Risk Reduction in Early Anemia Treatment with Epoetin Beta ** Correction of Hemoglobin and Outcomes in Renal Insufficiency *** Trial to Reduce Cardiovascular Events with Aranesp Therapy Finding the magic formula for ESA useErythropoiesis-stimulating agents have been called "wonder drugs" since the U.S. Food and Drug Administration approved the first one in the United States more than 20 years ago. Their image has been tarnished recently, as new studies suggest higher doses may cause harm. Federal regulators, phy -sicians, patients, and industry mem- bers gathered in Baltimore on March 24 to debate those concerns.Questions about too much ESA dosing have been raised in the past, although most of that focus has been about the cost to the ESRD pro-gram. Now, results from studies like CREATE,* CHOIR,** and TREAT*** are suggesting that using higher doses of ESAs to raise hemoglobin levels may have serious side effects: stroke and a higher risk of death. It remains unclear why those risks are heightened with higher doses, so it becomes difficult to estimate the dose that is both safe and effective in maintaining a high hemoglobin level. Secondarily, but just as impor -tant, is determining what the ideal hemoglobin range should be for both pre-dialysis and dialysis patients.The key focus of the Medicare Evidence Development & Coverage committee meeting was to evaluate use of ESAs in patients with chron-ic kidney disease. While the panel was not directed by CMS to gather FirstWord_NNI0510_5.indd 8 4/19/10 10:03:45 AM
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