AAKP Testifies Before MEDCAC Panel on ESA Use in Kidney Transplant

Tampa, FL; Thursday, January 20, 2011 – On Wednesday, January 19, 2011, the American Association of Kidney Patients (AAKP) testified before the Center for Medicare and Medicaid Services’(CMS) Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) on the impact of erythropoiesis stimulating agents (ESAs) for kidney transplant recipients. CMS called the meeting to review evidence on the use of ESAs that affect kidney transplant graft survival in patients who have both chronic kidney disease (CKD) and anemia.

Medicare currently does not have a national coverage determination for the use of ESAs for anemia in patients who have CKD. ESAs, marketed under the names Epogen, Procrit and Aranesp, are FDA-approved for the treatment of anemia resulting from chronic kidney failure, chemotherapy, certain treatments for HIV and to reduce the number of blood transfusions during and after certain major surgeries. The drugs work by stimulating the bone marrow to produce red blood cells.

Paul T. Conway, a transplant recipient from the Commonwealth of Virginia and Vice President of the AAKP Board of Directors gave the panel a brief history of how ESAs came to replace blood transfusions – and the benefits of ESAs over a blood transfusions for patients hopeful of receiving a kidney transplant. “Blood transfusions are not harmless. They can spread viruses such as hepatitis C and B. But, more relevant in the transplant patient, they cause an immunization-type reaction that induces a set of antibodies that will fight the new kidney transplant.” Conway went on to say, “As an informed patient and as an American taxpayer, it is important to me that our health care system continues to allow me the opportunity to choose optimal care in consultation with my doctor, particularly when that choice is cost effective. It is much less expensive over the years to sustain a patient with a kidney transplant than with dialysis. The data is compelling that blood transfusions sensitize patients to form high PRA levels, and take them out of the loop for a successful transplant. It is therefore important that the American health system continue to deploy strategies that will minimize blood transfusions.”

The panel also heard from AAKP’s Stephen Z. Fadem, MD, FACP, a member of the AAKP Board of Directors and AAKP Medical Advisory Board. Dr. Fadem spoke of an AAKP survey which demonstrated patients who receive a kidney transplant have the highest level of patient satisfaction. He went on to say, “In order to achieve that I want to maximize all conditions that allow them this chance, and likewise minimize challenges. It is convincingly observed that blood transfusions sensitize patients to form high levels of cytotoxic antibodies, diminishing their opportunity for a successful transplant. Perhaps, equipoise obviates the ability to ever study this further – but in the interim it appears in the kidney patient’s best interest to avoid a blood transfusion.”

Several studies have shown increased risk of cardiovascular problems associated with the long term use of ESAs in certain patients, the most notable being the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT), which was published in 2009. The FDA requires all ESAs to be prescribed under a risk evaluation and mitigation strategy (REMS) to help ensure proper use of ESAs on patients who need them.

To read the entire prepared statements of Paul Conway and Dr. Stephen Fadem to the CMS MEDCAC panel, please visit the AAKP web site, Public Comments & Correspondence Section. For more information about the American Association of Kidney Patients visit www.aakp.org or call 1-800-749-2257.

 

AAKP is the voluntary, patient organization, which for more than 35 years, has been dedicated to improving the lives of fellow kidney patients and their families by helping them deal with the physical, emotional and social impact of kidney disease. The programs offered by AAKP inform and inspire patients and their families to better understand their condition, adjust more readily to their circumstances, and assume more normal, productive lives in their communities.