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MEDCAC Meeting

Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease

01/30/2013

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Issue

The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review available evidence and hear public testimony on the use of beta amyloid PET imaging for the management of dementia and neurodegenerative disease. CMS is interested in the clinical impact of this technology on health outcomes experienced by patients.

PET is a minimally-invasive diagnostic imaging test. An injected radioactive tracer gives off subatomic particles, known as positrons, as it decays. PET uses a positron camera (tomograph) to measure the decay of these radioisotopes. The rate of tracer decay provides biochemical information on the tissue being studied. Certain PET tracers allow imaging of beta-amyloid plaque in the brain. It has been asserted that identification of such beta amyloid plaque can inform the clinical management of patients with cognitive impairment who are being evaluated for possible Alzheimer's disease or other causes cognitive decline.

Medicare currently does not cover beta amyloid PET imaging. Medicare addresses coverage of PET in section 220.6 of the National Coverage Determination (NCD) manual at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part4.pdf

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 HERE.

August 27, 2012

CMS posts MEDCAC meeting announcement.

October 24, 2012

Posted FR notice

October 31, 2012

Posted questions to panel.

January 24, 2013

Posted agenda, roster & speakers list for meeting. Also posted presentations.

January 31, 2013

Posted scoresheet from meeting.

March 5, 2013

Posted minutes [PDF, 135KB] and transcript [PDF, 359KB] from meeting.

Agenda

Federal Register Notice
Agenda
Medicare Evidence Development & Coverage Advisory Committee
January 30, 2013
7:30 AM – 4:30 PM
CMS Auditorium

Rita Redberg, MD, MSc, Chair
Art Sedrakyan, MD, PhD, Vice Chair
Louis Jacques, MD, Director, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 – 8:00 AM

Registration

8:00 – 8:10 AM

Opening Remarks— Maria Ellis/Louis Jacques, MD/Rita Redberg, MD

8:15 - 8:25 AM

CMS Presentation & Voting Questions – Joseph Hutter, MD/Brijet Burton Coachman, MPP, MS, PA-C

8:25 – 8:45 AM

Paul Aisen, MD, Department of Neurosciences, UCSan Diego School of Medicine

8:45 – 9:05 AM

Randall Bateman, MD, Charles F. and Joanne Knight Distinguished Professor of Surgery, Washington University School of Medicine

9:05 – 9:25 AM

Steven Pearson, MD, MSc, Institute for Clinical and Economic Review, Massachusetts General Hospital’s Institute for Technology Assessment

9:25 – 9:45 AM

William Thies, MD, Chief Medical and Scientific Officer, Alzheimer’s Association

9:45 – 10:05 AM

Mark Mintun, MD, Chief Medical Officer, Avid Radiopharmaceuticals (A wholly owned subsidiary of Eli Lilly and Company)

10:05 – 10:15 AM

BREAK

10:15 – 11:00 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.

11:00 – 11:05 AM

Open Public Comments

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

11:05 – 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. Redberg

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. Redberg

4:00 – 4:30 PM

Closing Remarks/Adjournment: Dr. Jacques & Dr. Redberg

Minutes

Download meeting minutes. [PDF, 135KB]

Panel Voting Questions

January 30, 2013 MEDCAC Questions
PET Beta Amyloid Imaging in the Context of Dementia

The primary focus of this MEDCAC meeting is the use of positron emission tomography (PET) imaging of brain beta amyloid to inform the clinical diagnosis and management of dementia. Among outcomes, CMS is most interested in patient function and quality of life.

We also seek the panel’s input on whether or not the published evidence identifies patient characteristics that predict improved health outcomes of patients who undergo PET imaging for beta amyloid. CMS recognizes that the impact of a diagnostic test result is generally derived from downstream changes in patient management rather than from the mere administration of the test, and that the avoidance of unnecessary or harmful treatment may also produce improved health outcomes.

Instructions: For the voting questions, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing high confidence.

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


Voting Questions

1a. How confident are you that there is adequate evidence to determine whether or not PET imaging of brain beta amyloid changes health outcomes (improved, equivalent or worsened) in patients who display early symptoms or signs of cognitive dysfunction?

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


1b. If there is at least intermediate confidence (mean score ≥ 2.5 in question 1a), how confident are you that PET imaging of brain beta amyloid improves health outcomes in patients who display early symptoms or signs of cognitive dysfunction?

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


Discussion

Please discuss the factors that led to your vote.

If there is at least intermediate confidence that PET imaging of brain beta amyloid improves health outcomes in patients who display early symptoms or signs of cognitive dysfunction (mean score ≥ 2.5 in question 1b), please proceed to question 2a. If not, please proceed to question 3.

2a. How confident are you that there is adequate evidence to identify patient characteristics that predict improved health outcomes of patients who undergo PET imaging for beta amyloid?

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


2b. If there is at least intermediate confidence there is adequate evidence to identify patient characteristics that predict improved health outcomes of patients who undergo PET imaging for beta amyloid (mean score ≥ 2.5 in question 2a), please identify and discuss the relative weight of those characteristics.

3. How confident are you that these conclusions are generalizable to the Medicare beneficiary population?

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


4. Please discuss any evidence gaps and the types of clinical studies that would be needed to confidently close those gaps.

Contact Information

Other Material

Roster

Rita Redberg, MD, MS Chair
Professor of Medicine
UCSF School of Medicine
Division of Cardiology
University of California, San Francisco Medical Center

Art Sedrakyan, MD, PhD Vice Chair
Associate Professor & Director
Patient Centered Comparative
Outcomes Research Program
Weill Cornell Medical School

Jeffrey W. Cozzens, MD, FACS
Attending Physician, Neurosurgery
Chair, Division of Neurosurgery
Southern Illinois University School of Medicine
SIU Physicians & Surgeons, Inc.

Raymond E. Faught, Jr., MD
Professor of Neurology
Associate Chief of Service
Chief, Neurology Service
Emory Neurology, MOT 7085
Emory University Hospital Midtown

A. Mark Fendrick, MD
Professor
Department of Internal Medicine
University of Michigan School of Public Health

Steven Gutman, MD
Strategic Advisor
Myraqa, Inc.

Paula E. Hartman-Stein, PhD
Associate Professor of Psychiatry,
Northeast Ohio Medical University
Senior Fellow, Institute for Life-Span Development and Gerontology
University of Akron
Clinical Geropsychologist
Center for Healthy Aging

Susan A. Levine, DVM, MS, PhD
Vice President
Technology Assessment/Editor-in Chief
Hayes, Inc.

Theresa Miskimen, MD
Vice President, Medical Services
Medical Director
University Behavioral Health Care
University of Medicine & Dentistry of New Jersey

Curtis Mock, MD, MBA
Senior Medical Director
Vice President Medicare Advantage
UnitedHealthcare Medicare & Retirement

Jerrold Rosenbaum, MD
Psychiatrist-in-Chief
Massachusetts General Hospital
Stanley Cobb Professor of Psychiatry
Harvard Medical School

Amy E. Sanders, MD, MS
Assistant Professor
Department of Neurology/Einstein Aging Study
Albert Einstein College of Medicine

Robert K. Zeman, MD
Professor and Chairman of Radiology
George Washington University School of Medicine
Diagnostic Radiology Residency Program
Director
Radiologist-in-chief (Radiology and Radiation Oncology)
George Washington University Medical
Faculty Associates, Inc., and Hospital

Industry Representative

Brian Seal, RPh, MBA, PhD
Director
Health Economics & Outcomes Research
Bayer HealthCare Pharmaceuticals Inc.

Guest Panel Members

Peter Herscovitch, MD
Director
PET Department
NIH Clinical Center

Constantine G. Lyketsos, MD, MHS
Johns Hopkins Medicine/Psychiatry & Behavioral Sciences

Invited Guest Speakers

Paul Aisen, MD
Department of Neurosciences
UCSan Diego School of Medicine

Randall J. Bateman MD
Charles F. and Joanne Knight Distinguished Professor of Neurology
Washington University School of Medicine

Mark Mintun, MD
Chief Medical Officer
Avid Radiopharmaceuticals (Avid)
Wholly Owned Subsidiary of Eli Lilly and Company (Lilly)/p>

Steven D. Pearson, MD, MSc, FRCP
Institute for Clinical and Economic Review Massachusetts General Hospital's Institute for Technology Assessment

William Thies, MD
Chief Medical and Scientific Officer
Alzheimer's Associatio

CMS Liaison

Louis Jacques, MD
Director
Coverage and Analysis Group

Executive Secretary

Maria Ellis
Coverage and Analysis Group

Speakers List

Medicare Evidence Development & Coverage Advisory Committee
January 30, 2013
SPEAKER LIST
*5 MINUTES PER SPEAKER*

  • Stephen Salloway, MD, MS, Director of Neurology and the Memoryand AgingProgram, Butler Hospital, Professor of Neurology and Psychiatry
    The Warren Alpert Medical School of Brown University - No Powerpoint Presentation

  • Howard Fillit, MD, Executive Director and Chief Scientific Officer, The Alzheimer's Drug Discovery Foundation

  • Norman L. Foster, MD, Director, Center for Alzheimer’s Care, Imaging and Research, Chief, Division of Cognitive Neurology, Professor, Department of Neurology, Senior Investigator, The Brain Institute, University of Utah

  • Sam Gandy, MD, PhD, Professor of Neurology and Psychiatry (Dual Primaries), Mount Sinai Chair in Alzheimer's Disease Research, Director, Center for Cognitive Health, Director, NFL Neurological Center, Associate Director, Mount Sinai Alzheimer's Disease Research Center

  • Carl Sadowsky MD, Medical Director, Premiere Research Institute, Clinical Professor of Neurology, Nova SE University

  • Mykol Larvie, MD, PhD, Department of Radiology, Divisions of Neuroradiology, and Nuclear Medicine, Massachusetts General Hospital and Molecular Imaging, Director of Clinical Molecular Neuroimaging, Harvard Medical School – Representing: American Society of Neuroradiology (ASNR) and the American Society of Functional Neuroradiology (ASFNR)

  • Richard Wahl, MD, Director, Division of Nuclear Medicine/PET, The Johns Hopkins Hospital – Representing: World Molecular Imaging Society (WMIS)

  • Richard Frank, MD, PhD, FrankHealthcare Advisers - Representing: Medical Imaging & Technology Alliance (MITA)

  • David Kuhlmann, MD, Board Certified, Neurology & Sleep Medicine, Bothwell Regional Health Center

  • Michael D. Devous, Sr., MD, Professor of Radiology, Director, Neuroimaging Cores, Alzheimer's Disease Center and North Texas Traumatic Brain Injury Model System, Associate Director, Nuclear Medicine Center, University of Texas Southwestern Medical Center - No Powerpoint Presentation

  • Teng J. Ong, MD, Global Head (Interim) Medical Affairs, GE Healthcare - No Powerpoint Presentation

Associated NCA

Associated Technology Assessment

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