TAMPA, Fla.—The American Association of Kidney Patients (AAKP) submitted on Jan. 31 a letter to the Centers for Medicare & Medicaid Services (CMS) on its concerns regarding the outcome of the recent Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).
Click HERE to read the letter.
At the January 19 meeting, MEDCAC reviewed evidence and heard from patient groups, including AAKP, and providers, on the use of erythropoiesis-stimulating agents (ESAs) and their effect on kidney transplant graft survival in patients who have both chronic kidney disease (CKD) and anemia. The Medicare panel said there isn't enough evidence to make any scientific decision on whether the use of ESAs makes kidney transplant patients less likely to reject the organ.
In its letter to CMS, AAKP wrote, “AAKP is very concerned with the CMS deliberations currently underway on ESA’s and we are concerned that if direct patient perspectives are ignored, a Federal decision – such as removing ESA’s from the market or limiting patient access to their use—will have direct and unhealthy implications for those awaiting transplants, those who are currently meaningfully employed and not dependent on taxpayer funded benefits and other patients within the kidney community who suffer from anemia.”
The panel also used information from the Technology Assessment (TA) Program at the Agency for Healthcare Research and Quality (AHRQ) to come to its decision. AAKP argued that the information provided is flawed and out-dated. In its letter, the patient association, “AAKP believes that the document is fundamentally flawed in terms of its ability to adequately inform potential policies or decisions based on the most recent scientific research. We firmly believe that policy-makers who rely on the study in its present form and its outdated information will make poorly reasoned decisions that will impact patients and their access to future care options.”
CMS is working to develop a payment policy for ESA use in kidney patients. 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. In 2006, published studies linked ESAs to an increased risk of heart attacks, heart failure, stroke, blood clots and death. In 2007, the FDA required ESAs to carry a black box warning – recommending they be used at the lowest dose necessary to prevent the need for transfusions.
Patients who suffer from anemia who do not receive an ESA must get a blood transfusion. AAKP’s said there is strong evidence that repeated blood transfusions lead to the development of antibodies that will fight a transplant kidney.
