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MEDCAC Meeting

The Impact of ESA Use on Renal Transplant Graft Survival

01/19/2011

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Issue

Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis: The Impact of ESA Use on Renal Transplant Graft Survival

CMS has called this meeting of the panel to review the available evidence on the use of erythropoiesis stimulating agents (ESAs) to affect renal (kidney) transplant graft survival in patients who have both chronic kidney disease (CKD) and anemia. Some parties claim that prior ESA use may predict the long term success of subsequent renal transplantation in patients with CKD.

Medicare currently does not have a national coverage determination for the use of ESAs for anemia in patients who have CKD. Medicare has historically made payment for ESAs for particular indications with specific conditions. ESAs are drugs or biologic agents which interact with the erythropoietin receptor or its pathway. The most common of these are recombinant (genetically man-made) forms of the native protein, human erythropoietin, or analogues (modified forms) of the native protein. Because ESAs stimulate the bone marrow to make erythrocytes (red blood cells), ESAs have been used to treat anemia.

Anemia, which has multiple causes, is not uncommon in some patient populations, such as those with CKD. ESAs have FDA approved labeling that includes boxed warnings citing greater risks for death, serious cardiovascular events, and stroke in patients with chronic renal failure.

Actions Taken


Tree/Earth - CMS Goes Green

CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED ON THE CMS WEBSITE PRIOR TO THE MEETING.



November 24, 2010

Posted questions to panel.

December 1, 2010

Posted Federal Register notice.

January 3, 2011

We will be broadcasting the meeting via Webinar. You must register for the Webinar portion of the meeting at https://webinar.cms.hhs.gov/esamedcac119/event/registration.html

January 13, 2011

Posted roster, agenda and speakers list for meeting.

January 13, 2011

Posted Technology Assessment for meeting.

January 18, 2011

Posted presentations and written comments for January 19 meeting.

January 21, 2011

Posted scoresheet [PDF, 46KB] from meeting.

March 10, 2011

Posted minutes [PDF, 1MB] and transcript [PDF, 341KB] from meeting.

Agenda

Federal Register Notice

Tree/Earth - CMS Goes Green

CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED ON THE CMS WEBSITE PRIOR TO THE MEETING.


 

 

 

Agenda
Medicare Evidence Development & Coverage Advisory Committee
January 19, 2011
7:30 AM - 4:30 PM
CMS Auditorium


Clifford Goodman, PhD, Chair
Saty Satya-Murti, MD, Vice Chair
James Rollins, MD, Division Director, Division of Items and Devices, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 - 8:00 AM

Registration

8:00 - 8:15 AM

Opening Remarks— Maria Ellis/James Rollins, MD/Clifford Goodman, PhD

8:15 - 8:35 AM

CMS Presentation & Voting Questions - Kimberly Long/Elizabeth Koller, MD

8:35 - 9:15 AM

TA Presentation: C. Michael White, PharmD, FCP, FCCP, University of Connecticut/Hartford Hospital EPC

9:15 - 9:30 AM 

James Bowman, MD, Medical Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration

9:30 - 9:45 AM

Jeffrey L Carson, MD, Richard C Reynolds Professor of Medicine
Chief, Division of General Internal Medicine, UMDNJ-Robert Wood Johnson Medical School

9:45 - 10:00 AM

J. Michael Cecka, PhD, Director of Clinical Research, Immunogenetics Center, University of California Los Angeles

10:00 - 10:10 AM 

BREAK

10:10 - 11:30 AM

Scheduled Public Comments
(Refer to Speaker List)

Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

11:30- 11:40 AM

Open Public Comments

Public Attendees who wish to address the panel will be given that opportunityp

11:40 - 12:00 PM

Questions to Presenters

12:00 - 1:00 PM

LUNCH (on your own)

1:00 - 2:00 PM

Initial Open Panel Discussion: Dr. Goodman

2:00 - 3:00 PM

Formal Remarks and Voting Questions

The Chairperson will ask each panel member to state his or her position on the voting questions

3:00 - 4:00 PM

Final Open Panel Discussion: Dr. Goodman

4:00 - 4:30 PM

Closing Remarks/Adjournment: Dr. Rollins & Dr. Goodman


Download PDF of agenda.

Minutes

Download meeting minutes [PDF, 1MB]

Panel Voting Questions

MEDCAC –January 19, 2011 QUESTIONS

Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis: The Impact of ESA Use on Renal Transplant Graft Survival

ESAs are used with the intention of reducing the need for red blood cell transfusion and thereby minimize immune sensitization as detected by panel reactive antibody (PRA) assays.  PRA may be predictive of renal transplant graft survival.  Some have proposed, therefore, that ESAs increase the survival of renal transplant grafts.

For the voting questions, use the following scale identifying level of confidence - with 1 being the lowest or no confidence and 5 representing a high level of confidence.  Please consider the questions in light of the following descriptive model.

1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

  1. How confident are you that there is adequate evidence to determine whether or not current panel reactive antibody (PRA) assays predict renal transplant graft survival for individual patients (in contrast to populations)?

1      —      2      —      3      —      4      —      5

  1. If the result of Question 1 is at least Intermediate (mean vote ≥ 2.5) how confident are you that current PRA assays predict renal transplant graft survival for individual patients?

1      —      2      —      3      —      4      —      5

Discussion for Question 2:

  • How do PRA assays relate to more specific tests of HLA sensitivity and whether titer levels predict specific organ HLA sensitivity?
  • Are the various proprietary PRA assays clinically interchangeable, i.e. would the treating physician’s management of the patient differ depending on the specific assay?
  • Do current PRA assays provide the same clinical information as older assays, i.e. do historical data on the performance of PRA assays apply to currently available assays?

  1. Donor-specific blood transfusions were frequently employed prior to renal transplantation for immune modulation and improved graft survival. These differ from therapeutic blood transfusions, which are performed for anemia/blood loss management.

    How confident are you that there is adequate evidence whether or not therapeutic blood transfusions decrease renal transplant graft survival?

1      —      2      —      3      —      4      —      5

  1. If the result of Question 3 is at least Intermediate (mean vote ≥ 2.5) how confident are you that therapeutic blood transfusions decrease renal transplant graft survival?

1      —      2      —      3      —      4      —      5

Discussion for Question 4:

  • The relative roles of sensitization as opposed to underlying co-morbid conditions in affecting renal transplant graft survival.
  • The adequacy of the evidence base on the relationship if any between the number of units transfused and renal transplant graft survival. For example, is there a threshold number of units that predict renal transplant graft survival or is there a linear or exponential relationship between the number of units transfused that predict renal transplant graft survival? 
  • The relative roles of blood transfusions, pregnancy, prior renal transplant, and other factors that cause sensitization.
  1. How confident are you that there is adequate evidence to determine whether or not ESA use for anemia/blood loss management improves renal transplant graft survival? 

1      —      2      —      3      —      4      —      5

  1. If the result of Question 5 is at least Intermediate (mean vote ≥ 2.5) how confident are you that there is adequate evidence to conclude that ESA use to maintain hemoglobin levels >10 g/dl is necessary to improve renal transplant graft survival?

1      —      2      —      3      —      4      —      5

  1. What significant evidence gaps exist regarding the clinical criteria, including hemoglobin level, of patients who should receive blood transfusions for chronic anemia with the intent of improving renal transplant graft survival?

  1. What significant gaps exist regarding the relationship, if any, of number of units transfused, screening PRA assays, more specific HLA assays, immune suppressive regimen, and the timing of rejection to determine the role various factors in transplant graft survival outcomes?

END

Download scoresheet [PDF, 46KB].

Contact Information

Other Material

Roster

Tree/Earth - CMS Goes Green

CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED ON THE CMS WEBSITE PRIOR TO THE MEETING.




MEDCAC Roster
January 19, 2011

Clifford Goodman, PhD CHAIR
Senior Vice President
The Lewin Group

Saty Satya-Murti, MD, FAAN VICE CHAIR
Health Policy Consultant

Renè Cabral-Daniels, JD, MPH
Chief of Staff
National Patient Advocate Foundation

Roger Dmochowski, MD
Department of Urology
Vanderbilt University

Leslie Grammer, MD
Interim Chief Feinberg School of Medicine
Division of Allergy-Immunology
Northwestern University

Roger D. Klein, MD, JD
Medical Director
Molecular Oncology
BloodCenter of Wisconsin

David M. Mintzer, MD
Chief
Section of Hematology & Medical Oncology
Medical Director
Pain & Supportive Care Services
Pennsylvania Hospital
Clinical Associate
Professor of Medicine
University of Pennsylvania

David J. Samson, MS
BlueCross BlueShield Association
Washington, DC 20005

Ajay Singh, MBBS, FRCP, MBA
Physician
Renal Division
Brigham and Women’s Hospital
Associate Professor of Medicine
Harvard Medical School

Jeffrey L. Carson, MD
Richard C. Reynolds Professor of Medicine
Chief
Division of General Internal Medicine
University of Medicine and Dentistry
New Jersey
Robert Wood Johnson Medical School

J. Michael Cecka, PhD
Director of Clinical Research,
University of California Los Angeles Immunogenetics Center

Robert L. Steinbrook, MD
Adjunct Associate Professor of
Medicine and Community and Family
Medicine
Dartmouth Medical School

Industry Representative

Lester D. Paul, MD, MS
Senior Vice President
Medical Affairs
Caris Life Sciences

Guest Panel Members

Jerry A. Holmberg, PhD
Senior Advisor for Blood Safety
Executive Secretary of the Advisory
Committee on Blood Safety and
Availability, HHS

David Stroncek, MD
National Institutes of Health
Clinical Center
Department of Transfusion Medicine

Invited Guest Speakers

James Bowman, MD
Medical Director
Division of Transplantation
Healthcare Systems Bureau
Health Resources and Services Administration

CMS Liaison

James Rollins, MD
Director
Division of Items and Devices
Coverage and Analysis Group

Executive Secretary

Maria Ellis
Coverage and Analysis Group

Download PDF of roster.

Speakers List

Tree/Earth - CMS Goes Green

CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED ON THE CMS WEBSITE PRIOR TO THE MEETING.




Medicare Evidence Development & Coverage Advisory Committee
January 19, 2011

SPEAKER LIST

*4 MINUTES PER SPEAKER*

  • Bryan Becker, MD, Professor of Medicine, Executive Director of the University of Illinois Physicians Group Medical Service Plan, Senior Associate Dean for Clinical Affairs, University of Illinois at Chicago, College of Medicine - Representing:  National Kidney Foundation
  • Ruben Velez, MD,  Nephrologist, Dallas, Texas - Representing:  Renal Physicians Association
  • Mandy Trolinger, MS, RD, PA-C -  Representing:  The Renal Support Network
  • Nancy H. Spaeth, RN, Seattle, Washington
  • Jonathan S. Bromberg, MD, PhD, Professor of  Surgery and Microbiology and Immunology, Transplant Program, University of Maryland School of Medicine and Hospital
  • Denise Eilers, BSN, RN, Davenport, Iowa
  • Tracy McGowan, MD, Centocor Ortho Biotech, LP, (a Johnson & Johnson Company)
  • Barry von Hartitzsch, MB.ChB, FRACP, FACP, Nephrology Specialist of Oklahoma, Tulsa, Oklahoma
  • M. Sue Leffell, PhD, D.ABMLI, D.ABHI, Professor and Laboratory Director, JHU Immunogenetics Laboratory, The Johns Hopkins University School of Medicine - Representing:  The American Society for Histocompatibility and Immunogenetics
  • Lawrence T. Goodnough, MD, Professor of Pathology & Medicine, Director of Transfusion Service, Director, Transfusion Medicine Fellowship Program, Associate Medical Director, Stanford Blood Center, Department of Pathology, Stanford University Medical Center, Stanford, California
  • Gail Wick, MHSA, BSN, RN, CNN, Trustee for the American Kidney Fund Board of Trustees
  • Glenn M. Chertow, MD, MPH, Norman S. Coplon/Satellite Healthcare Professor of Medicine, Stanford University School of Medicine, Chief, Division of Nephrology
  • Stephen Z. Fadem, MD, FASN, Clinical Nephrologist and Medical Director, Dialysis Centers in Houston, Texas
  • Reshma Kewalramani, MD, Nephrology Therapeutic Area Head, Vice President, Global Development, Amgen, Inc.
  • William E. Harmon, MD, FASN, Director of the Nephrology, Division of Children's Hospital Boston and Professor of Pediatrics at Harvard Medical School - Representing:  American Society of Nephrology
  • Kathleen LeBeau, weKAN Program Manager, Renal Support
  • Paul T. Conway, Vice President, American Association of Kidney Patients and Chair of the American Association of Kidney Patients Public Policy Committee

Download PDF of speakers list.

Associated NCA

Associated Technology Assessment

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