December 20, 2010

Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services,
Office of Clinical Standards and Quality, Coverage and Analysis Group
C1–09–06
7500 Security Boulevard, Baltimore, MD 21244

Dear Ms. Ellis,

Dialysis Patient Citizens (DPC) would like to thank you for again providing us with the opportunity to submit comments in advance of the second Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting to discuss the use of erythropoiesis stimulating agents (ESAs) to manage anemia in patients who have chronic kidney disease (CKD).  DPC is America’s largest dialysis patient organization with over 22,000 members.  On a wide variety of issues we seek to ensure the patients’ point of view is heard by decision makers.  With the evidence for the use of ESAs in patients with kidney disease being discussed again by the second advisory panel at the upcoming January 19 MEDCAC meeting, we would like to ensure the following areas important to patients with CKD are considered prior to further policy changes on coverage for ESAs:

Quality of Life
As you are aware anemia is a serious condition that causes fatigue, weakness and increased risk of hospitalization and death.  In most cases, the administration of synthetic replacements for the hormone erythropoietin can help manage patients’ anemia and restore their energy. With appropriate anemia management, patients require less medical attention and hospitalization, fewer transfusions and are better able to lead productive, quality lives.  ESAs have made a positive difference in the lives of patients with kidney disease by not only helping them avoid blood transfusions, but also by allowing patients to achieve closer to normal hemoglobin levels – providing patients with the energy needed to work, volunteer and care for their families, which are essential to having a good quality of life.  Other quality of life indicators such as sexual function, cognitive function and capacity to exercise have also shown improvement with treatment of anemia.  As is the case in the administration of most therapies, treatment for anemia should be considered when patients’ health and quality of life are at risk and this decision should be made by patients in consultation with their doctors. Initiation of treatment should not be based solely on avoidance of a blood transfusion or on lab test results, but should also consider the symptoms patients are experiencing at a particular hemoglobin level. 

Transfusions and Transplantation
We are concerned about the line of questioning that will be posed to committee members and panelists at the January 19 MEDCAC meeting.  Patients know from experience that antibody levels in those who have received blood transfusions are scrutinized prior to a decision being made on whether or not the patient can receive a kidney transplant.  However, we feel this line of questioning is narrow in its focus.  While a kidney transplant is widely accepted as the best form of treatment for individuals with kidney failure it excludes over 80 percent of dialysis patients who are not currently on the transplant list and the many who may never be eligible for a kidney transplant.  Continuous improvements in the quality of care and quality of life for individuals on dialysis need to be a focus for CMS.  With continued advancements in treatments and medications for dialysis patients there is potential for patients to live long quality lives, but reimbursement policies need to be aligned to allow for these improvements.  

Patient and Physician Relationship
We appreciate that CMS shares with DPC the goal to ensure quality care for beneficiaries with CKD.  An essential component to quality care is that it be patient-centered, which is defined by the Institute of Medicine as “respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.”  Physicians in consultation with their patients should have the autonomy to prescribe the most appropriate medications to treat their patients.  DPC believes financial factors should not influence physicians’ decisions to recommend the most optimal course of therapy, and we advocate for a coverage policy that does not provide incentives for physicians to under or overprescribe ESAs. Physicians should discuss with their patients all the risk factors associated with using ESAs to treat anemia in kidney patients, as well as the risks of forgoing ESA therapy, so patients can make well-informed decisions.

Cardiovascular Complications
Cardiovascular complications are the leading cause of death for dialysis patients.  Studies have also shown that both CKD and anemia are related to increased death due to heart failure and early hospital readmission in patients with CKD.  New studies on the use of ESAs in CKD patients not yet on dialysis have also indicated an increase in cardiovascular deaths due to stroke, which is what sparked the FDA black box label in 2007.  Current medical evidence may suggest risks associated with the use of ESAs; however, there are also serious risks associated with forgoing ESA therapy, including the many risks of blood transfusions.  Patients should be advised of the risks on both sides, but ultimately these decisions need to be made by patients after consultation with their physicians.

CKD and ESRD
Studies that spurred the FDA to create a black box label for the use of ESAs in patients with kidney disease were conducted on patients with CKD in stages 1-4.  However, the warning label was also applied to the dosing of patients with CKD stage 5 and those on dialysis.  Patients not on dialysis and those on dialysis have differing needs and should be treated accordingly.  Patients on dialysis have progressed to the end-stage of CKD and as a result often have other medical conditions and complications not seen in patients in the earlier stages of CKD.  Further research on the treatment of anemia and safe hemoglobin levels should be conducted to discover if the same risk factors in treating anemia in pre-dialysis patients apply to patients on dialysis as well.

Conclusion
Since 1989 ESAs have provided kidney patients with a therapy that has led to improvements in their health and quality of life.  While the risks of improper use of ESAs should not be ignored, it is important that reimbursement policies do not infringe upon the ability of patients and physicians together weighing the risks and benefits of treatment options. 

On behalf of our members and Board of Directors, I thank you for the opportunity to provide the patient perspective on the use of ESAs to manage anemia in kidney patients. 

Sincerely,
 

Tonya L. Saffer
Interim Executive Director