February 22, 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 providing us with the opportunity to provide comments in advance of the 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).  With over 22,000 members DPC is America’s largest dialysis patient organization.  On a wide variety of issues we seek to ensure the patients’ point of view is heard by decision makers.  As the evidence for the use of ESAs in patients with kidney disease is discussed at the upcoming March 24th 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 once a patient’s symptoms become severe enough to impact their health and quality of life.  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.  

Additionally, treatment of anemia should be ongoing, and reductions in dosage need to be gradual in order to keep patients from “riding the anemia rollercoaster.”  If ESA administration is completely cut off once a patient reaches a specific hemoglobin target they run the risk of crashing and possibly requiring even more ESAs to boost their hemoglobin back up to optimal levels.  Patients can feel the slightest difference in their hemoglobin levels.  To avoid this dangerous and physically taxing scenario doses should be gradually titrated down until the patient’s hemoglobin is within a safe range, but at a point where the patient still benefits from an improved quality of life.

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.  Patients should be advised of the risks on both sides, but ultimately these decisions need to be made by physicians 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 are two very different groups and should be treated accordingly.  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.

Transplantation
Transplant centers have different requirements patients must meet in order to be considered for the kidney transplant waiting list; however, anemia management and the avoidance of transfusions is widely looked at as a determining factor.  Any changes to coverage and reimbursement of ESAs could impact a patient’s anemia and their ability to get on the kidney transplant list.

Racial Disparities
CMS has noted data shows that African American patients often require higher doses of ESAs to achieve the same target hemoglobin as white patients.  Placing restrictive limitations on the units of ESAs Medicare will cover per month could increase disparities in care.  Coverage decisions must protect all patients and consider this variability in order to avoid disparities in outcomes.  

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.

ESAs in the New PPS
DPC believes the new prospective payment system for ESRD treatment together with a robust quality incentive program has the potential to remove perceived financial incentives and improve patient outcomes related to proper management of anemia.  However, if the cost of providing the proper dosing for patients to maintain a hemoglobin level between 10g/dl and 12g/dl is not accounted for in the new payment system, there could be severe consequences to patients of their anemia being under treated. Additionally, the proposed PPS released by CMS on September 16, 2009 poses the risk of an increase in patients with hemoglobin levels below 10g/dl.  Therefore, DPC suggested that only a quality measure that puts a check on underutilization is necessary since bundling the medication into the composite rate already checks overutilization. This would keep intact the proposed goal of maintaining the majority of patients’ hemoglobin levels between 10g/dl and 12g/dl.  

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 these risks are weighed against the benefits before making coverage determinations that could risk patients’ health and quality of life.  We also look forward to further research on anemia management for dialysis patients separate from those in stages 1-4 of CKD to assess the risks associated with a hemoglobin target beyond12 g/dl.  We feel it is important to point out a hemoglobin level of 12g/dl is still classified as being anemic.  Before any further changes to coverage of ESAs is implemented, we request a monitoring system be developed that would track not only patient outcomes, but allow for patients to directly provide input to CMS on their quality of life.
 
DPC looks forward to continued advances in the treatment of anemia and particularly towards ways to safely bring patients to a target hemoglobin that is as close to their normal range as possible.

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,

 
Chad Lennox
Executive Director