Appendix A

Workshop Agenda

Assessing the Economics of Genomic Medicine: A Workshop July 17-18, 2012

National Academy of Sciences Building
2101 Constitution Avenue, NW
Washington, DC 20037

WORKSHOP OBJECTIVE

To advance discussions around the clinical implementation of genetic and genomic technologies by examining costs associated with the development and use of genetic and genomic information in the care of individual patients.

Day 1

July 17, 2012

7:45 A.M.-8:30 A.M.

WORKING BREAKFAST

8:30 A.M.-8:35 A.M.

WELCOMING REMARKS

 

Wylie Burke, Roundtable Co-Chair, Meeting Moderator

 

Professor and Chair, Department of Bioethics and Humanities, University of Washington



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Appendix A Workshop Agenda Assessing the Economics of Genomic Medicine: A Workshop July 17–18, 2012 National Academy of Sciences Building 2101 Constitution Avenue, NW Washington, DC 20037 WORKSHOP OBJECTIVE To advance discussions around the clinical implementation of genetic and genomic technologies by examining costs associated with the development and use of genetic and genomic information in the care of individual patients. Day 1 July 17, 2012 7:45 A.M.–8:30 A.M. WORKING BREAKFAST 8:30 A.M.–8:35 A.M. WELCOMING REMARKS Wylie Burke, Roundtable Co-Chair, Meeting Moderator  Professor and Chair, Department of Bioethics and Humanities, University of Washington 77

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78 THE ECONOMICS OF GENOMIC MEDICINE 8:35 A.M.–8:40 A.M. CHARGE TO WORKSHOP SPEAKERS AND PARTICIPANTS W. Gregory Feero, Workshop Chair  Special Advisor to the Director, National Human Genome Research Institute 8:40 A.M.–10:10 A.M. SESSION I: ECONOMICS AND GENOMICS Moderators: W. Gregory Feero, National Human Genome Research Institute Wylie Burke, University of Washington 8:40 A.M.–9:10 A.M. Genomics, Population Health, and Technology James P. Evans  Bryson Distinguished Professor of Genetics and Medicine, University of North Carolina at Chapel Hill 9:10 A.M.–9:25 A.M. Discussion 9:25 A.M.–9:55 A.M. Intersection of Genomics and Health Economics David L. Veenstra  Professor, Pharmaceutical Outcomes Research and Policy Program, University of Washington 9:55 A.M.–10:10 A.M. Discussion 10:10 A.M.–10:25 A.M. BREAK SESSION II: PRECONCEPTION CARE AND 10:25 A.M.–12:20 P.M.  SEQUENCING Moderators: Robert L. Nussbaum, University of California, San Francisco, School of Medicine Wylie Burke, University of Washington

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APPENDIX A 79 Case Presentation: In 2012 a 35-year-old 10:25 A.M.–10:30 A.M.  healthy Ashkenazi Jewish female smoker is seen for a preconception visit. Under the current standard care model, targeted carrier status testing is offered. In terms of high effect size variations that would be detected by traditional genetic testing, she is found to be a carrier for Tay-Sachs. In addition, if testing were extended in this scenario beyond what might be considered to be current standard of care, she would be found to harbor a prothrombin gene mutation, as well as variations in CYP2C9 and VKORC, indicating that she is likely to be highly sensitive to warfarin anticoagulation. She is also homozygous for APOE4, but does not have familial hypercholesterolemia. She can be expected to have lower risk variants and variants of unknown significance in accordance with expected population frequencies for the conditions under consideration. 10:30 A.M.–11:00 A.M. Stakeholder Presentations (10 minutes each) Clinician: Siobhan M. Dolan  Associate Professor of Clinical Obstetrics and Gynecology and Women’s Health, Albert Einstein College of Medicine Futurist: Arthur L. Beaudet  Henry and Emma Meyer Professor and Chair, Department of Molecular and Human Genetics, Baylor College of Medicine Patient: Michelle Gilats  Genetic Counselor, Chicago Center for Jewish Genetics

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80 THE ECONOMICS OF GENOMIC MEDICINE 11:00 A.M.–11:20 A.M. Discussion with Speakers and Participants 11:20 A.M.–12:20 P.M. Economics Panel Discussion Moderator: David L. Veenstra, University of Washington Panelists: Paul R. Billings Chief Medical Officer, Life Technologies Scott Grosse  Research Economist and Associate Director for Health Services Research and Evaluation, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention Scott Ramsey  Full Member, Cancer Prevention Program, Division of Public Health Science, Fred Hutchinson Cancer Research Center 12:20 P.M.–1:05 P.M. LUNCH SESSION III: UNPROVOKED DVT/ 1:05 P.M.–3:00 P.M.  PULMONARY EMBOLISM Moderators: Frederick Chen, University of Washington Wylie Burke, University of Washington 1:05 P.M.–1:10 P.M. Case Presentation: The individual is seen at 40 years of age with progressive left lower extremity swelling and pain. Evaluation reveals an unprovoked deep vein thrombosis in her left lower extremity. She will be treated as an outpatient with low-molecular-weight heparin and warfarin. Targeted testing includes CYP2C9 and VKORC gene analysis.

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APPENDIX A 81 1:10 P.M.–1:40 P.M. Stakeholder Presentations (10 minutes each) Clinician: Michael F. Murray  Clinical Chief, Genetics Division, Department of Medicine, Brigham and Women’s Hospital Futurist: Euan A. Ashley  Director, Center for Inherited Cardiovascular Disease, Stanford University School of Medicine Patient: John West Chief Executive Officer, Personalis, Inc. 1:40 P.M.–2:00 P.M. Discussion with Speakers and Participants 2:00 P.M.–3:00 P.M. Economics Panel Discussion Moderator: David L. Veenstra, University of Washington Panelists: Paul R. Billings Chief Medical Officer, Life Technologies Scott Grosse  Research Economist and Associate Director for Health Services Research and Evaluation, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention

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82 THE ECONOMICS OF GENOMIC MEDICINE Scott Ramsey  Full Member, Cancer Prevention Program, Division of Public Health Science, Fred Hutchinson Cancer Research Center 3:00 P.M.–3:15 P.M. BREAK SESSION IV: CANCER CARE AND 3:15 P.M.–5:10 P.M.  SEQUENCING Moderators: Timothy J. Ley, Washington University School of Medicine Wylie Burke, University of Washington 3:15 P.M.–3:20 P.M. Case Presentation: The individual is seen at age 50 with cough, dyspnea, and chest discomfort. Evaluation reveals a lung mass; bronchoscopy and biopsy reveal a non-small-cell lung cancer. Her tumor is found to have variations that allow the use of targeted therapy, and with treatment the patient goes into remission. 3:20 P.M.–3:50 P.M. Stakeholder Presentations (10 minutes each) Clinician: Kenneth Offit  Chief, Clinical Genetics Service, Department of Human Genetics, Memorial Sloan- Kettering Cancer Center Futurist: Stephen Eck  Vice President, Global Head of Medical Oncology, Astellas Pharma Global Development

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APPENDIX A 83 Patient: Richard Heimler Lung Cancer Survivor and Advocate 3:50 P.M.–4:10 P.M. Discussion with Speakers and Participants 4:10 P.M.–5:10 P.M. Economics Panel Discussion Moderator: David L. Veenstra, University of Washington Panelists: Paul R. Billings Chief Medical Officer, Life Technologies Scott Grosse  Research Economist and Associate Director for Health Services Research and Evaluation, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention Scott Ramsey  Full Member, Cancer Prevention Program, Division of Public Health Science, Fred Hutchinson Cancer Research Center 5:10 P.M.–5:20 P.M. WRAP-UP DAY 1 W. Gregory Feero, Workshop Chair  Special Advisor to the Director, National Human Genome Research Institute 5:20 P.M. ADJOURN DAY 1

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84 THE ECONOMICS OF GENOMIC MEDICINE Day 2 July 18, 2012 7:45 A.M.–8:30 A.M. WORKING BREAKFAST 8:30 A.M.–8:35 A.M. WELCOMING REMARKS W. Gregory Feero, Workshop Chair  Special Advisor to the Director, National Human Genome Research Institute 8:35 A.M.–11:45 A.M. Session V: Research Economics 8:35 A.M.–9:00 A.M. Overview of Major Themes and Research Questions from Day 1 W. Gregory Feero, Workshop Chair  Special Advisor to the Director, National Human Genome Research Institute 9:00 A.M.–10:00 A.M. Stakeholder Perspectives on Research Questions Moderator: Wylie Burke, University of Washington Clinician: James P. Evans  Bryson Distinguished Professor of Genetics and Medicine, University of North Carolina at Chapel Hill Researcher: Katrina Armstrong  Professor of Medicine; Associate Director, Abramson Cancer Center; Division Chief, Division of General Internal Medicine, Department of Medicine, University of Pennsylvania School of Medicine

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APPENDIX A 85 Industry: Thomas J. White  Chief Scientific Officer (Retired), Celera Corporation; Regents’ Lecturer, University of California, Berkeley Patient: Mary Lou Smith Cofounder, Research Advocacy Network Public Health: Ned Calonge  President and Chief Executive Officer, The Colorado Trust Hospital System: Herbert Pardes  Professor of Psychiatry and Former Chief Executive Officer, New York–Presbyterian Hospital 10:00 A.M.–10:30 A.M. Audience Perspectives 10:30 A.M.–10:45 A.M. BREAK 10:45 A.M.–11:45 A.M. Economics Panel Discussion Moderator: David L. Veenstra, University of Washington Panelists: Paul R. Billings Chief Medical Officer, Life Technologies

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86 THE ECONOMICS OF GENOMIC MEDICINE Scott Grosse  Research Economist and Associate Director for Health Services Research and Evaluation, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention Scott Ramsey  Full Member, Cancer Prevention Program, Division of Public Health Science, Fred Hutchinson Cancer Research Center 11:45 A.M.–12:00 P.M. SESSION VI: WRAP-UP 11:45 A.M.–12:00 P.M. Concluding Remarks W. Gregory Feero, Workshop Chair  Special Advisor to the Director, National Human Genome Research Institute 12:00 P.M. WORKSHOP ADJOURNS