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

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=66 | meeting_date=2013-01-30

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: 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. Webcast of meeting Registration Information about visiting CMS Driving directions to CMS Recommended hotels 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 Associated Nca: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N) 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 Minutes: Download meeting minutes . [PDF, 135KB] Other Material: Transcript 1 Written comments 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. 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