Appendix A

Workshop Agenda

Assessing Genomic Sequencing Information for Health Care
Decision Making: A Workshop


February 3, 2014

The Keck Center of the National Academies, Room 100
500 Fifth Street, NW
Washington, DC 20001

MEETING OBJECTIVES


  • Provide a forum for diverse stakeholders to present approaches for assessing genome sequencing information for clinical use.
  • Compare and contrast evidence evaluation processes for different clinical indications and across stakeholders.
  • Identify key challenges in the evidence evaluation process.
  • Elicit pragmatic approaches to facilitate the effective translation of genomics into the clinic by improving evidence-based policy development.


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Appendix A Workshop Agenda Assessing Genomic Sequencing Information for Health Care Decision Making: A Workshop February 3, 2014 The Keck Center of the National Academies, Room 100 500 Fifth Street, NW Washington, DC 20001 MEETING OBJECTIVES • Provide a forum for diverse stakeholders to present approaches for assessing genome sequencing information for clinical use. • Compare and contrast evidence evaluation processes for different clinical indications and across stakeholders. • Identify key challenges in the evidence evaluation process. • Elicit pragmatic approaches to facilitate the effective translation of genomics into the clinic by improving evidence-based policy development. 73

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74 GENOME SEQUENCE INFORMATION IN HEALTH CARE DECISIONS AGENDA 8:30–8:35 a.m. Welcoming Remarks Sharon F. Terry, Roundtable Co-Chair President and Chief Executive Officer Genetic Alliance Geoffrey Ginsburg, Roundtable Co-Chair Director, Genomic Medicine, Duke Institute for Genome Sciences & Policy Executive Director, Center for Personalized Medicine, Duke Medicine Professor of Medicine and Pathology, Duke University Medical Center 8:35–8:45 a.m. Charge to Workshop Speakers and Participants David Veenstra Professor, Pharmaceutical Outcomes Research and Policy Program University of Washington SESSION I: HOW EVIDENCE IS GATHERED AND ASSESSED/GRADED/EVALUATED Moderator: Debra Leonard, University of Vermont 8:45–10:15 a.m. Systematic Evidence Gathering and Actionability Determination • What process do you use to identify studies and data? • How are you selecting tests/variants for full evidence review and assessment? • How do you critically assess the data and synthesize for conclusion? • How do you present the results of the evidence review and evaluation to policy makers?

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APPENDIX A 75 • How do you determine if clinical action is recommended or taken for specific genomic variants? • How do you define actionability? • What are the challenges you have encountered? • What have you done to overcome these challenges? Jonathan Berg Assistant Professor Department of Genetics University of North Carolina School of Medicine Katrina Goddard Senior Investigator Kaiser Permanente Center for Health Research Shashikant Kulkarni Director of Cytogenomics and Molecular Pathology Genomics and Pathology Services Washington University School of Medicine Heidi Rehm Associate Professor of Pathology, Brigham and Women’s Hospital and Harvard Medical School Director, Laboratory for Molecular Medicine Partners Healthcare Center for Personalized Genetic Medicine Madhuri Hegde Executive Director, Emory Genetics Laboratory Professor, Department of Human Genetics Emory University School of Medicine

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76 GENOME SEQUENCE INFORMATION IN HEALTH CARE DECISIONS Mark Robson Clinic Director, Clinical Genetics Service Department of Human Genetics Memorial Sloan–Kettering Cancer Center 10:15–10:30 a.m. BREAK 10:30–11:30 a.m. Discussion with Speakers and Attendees 11:30 a.m.–12:30 p.m. WORKING LUNCH SESSION II: PROCESS FOR DECISION MAKING ONCE EVIDENCE IS ASSESSED/GRADED/EVALUATED Moderator: Bruce Blumberg, Kaiser Permanente 12:30–1:00 p.m. Reimbursement Decisions • Under what process (existing or novel) would genome or multi-gene panel sequencing be evaluated? Describe the process. • What are your criteria for coverage? • Does the extent to which information is reported in the electronic health record affect your decision? • Under what circumstances are high- throughput sequencing tests covered by payers? Robert McDonough Head of Clinical Policy and Research Aetna Louis Jacques Director, Coverage and Analysis Group Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services 1:00–1:35 p.m. Discussion with Speakers and Attendees

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APPENDIX A 77 Moderator: Muin Khoury, Centers for Disease Control and Prevention 1:35–2:20 p.m. Guideline Development • How are you applying your guideline development process to next-generation sequencing? • What do you think are the top three challenges to developing guidelines in the era of next-generation sequencing? • Do you consider the Institute of Medicine recommendations for developing clinical practice guidelines in your process? Robert C. Green Director, Genomes to People (G2P) Research Program Associate Director for Research, Partners Center for Personalized Genetic Medicine Division of Genetics, Department of Medicine Brigham and Women’s Hospital and Harvard Medical School Howard M. Saal Director, Clinical Genetics Division of Human Genetics Cincinnati Children’s Hospital Medical Center Gary Lyman Co-Director, Hutchinson Institute for Cancer Outcomes Research Fred Hutchinson Cancer Research Center University of Washington 2:20–2:55 p.m. Discussion with Speakers and Attendees 2:55–3:10 p.m. BREAK

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78 GENOME SEQUENCE INFORMATION IN HEALTH CARE DECISIONS Moderator: W. Gregory Feero, Maine Dartmouth Family Medicine 3:10–4:10 p.m. Patient Care and Health Decisions • Upon what evidence is the decision made to use large-scale sequencing over a more targeted approach? • Does reimbursement play a role in ordering a whole genome test? • How do you see the role of patient preferences in what testing is done and what information is disclosed? • How well do patients understand discussions about genomic testing? And, what is the patient response to reports of incidental findings? Kathleen Hickey Assistant Professor of Nursing Columbia University School of Nursing Jessica Everett Clinical Instructor, Internal Medicine Certified Genetic Counselor Cancer Genetics Clinic University of Michigan Amy Hower Neuroscientist and Patient Michael Gambello Associate Professor of Human Genetics and Pediatrics Section Chief, Division of Medical Genetics Emory University School of Medicine 4:10–4:45 p.m. Discussion with Speakers and Attendees

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APPENDIX A 79 SESSION III: NEXT STEPS AND ADDRESSING CHALLENGES Moderator: David Veenstra, University of Washington 4:45–5:30 p.m. Developing Transparent and Pragmatic Frameworks for Evidence Evaluation and Policy Development in the Absence of an Ideal Evidence Base • What are the top three challenges to developing clinical and reimbursement policies in the era of genomic testing? • What approaches do you think can help address these challenges? • To what extent does clinical context matter? • How do risk–benefit tradeoffs influence evidentiary requirements? Jonathan Berg Assistant Professor Department of Genetics University of North Carolina School of Medicine Jessica Everett Clinical Instructor, Internal Medicine Certified Genetic Counselor Cancer Genetics Clinic University of Michigan Katrina Goddard Senior Investigator Kaiser Permanente Center for Health Research Robert C. Green Director, Genomes to People (G2P) Research Program Associate Director for Research Partners Center for Personalized Genetic Medicine Division of Genetics, Department of Medicine

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80 GENOME SEQUENCE INFORMATION IN HEALTH CARE DECISIONS Brigham and Women’s Hospital and Harvard Medical School Shashikant Kulkarni Director of Cytogenomics and Molecular Pathology Genomics and Pathology Services Washington University School of Medicine Robert McDonough Head of Clinical Policy and Research Aetna 5:30–5:45 p.m. Summary and Concluding Remarks 5:45 p.m. ADJOURN