Appendix A

Workshop Agenda

Implementing and Evaluating Genomic Screening Programs in Health Care Systems:
A Workshop
November 1, 2017

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

BACKGROUND

Genomic applications can be embedded into a broad range of clinical and research activities. Increasing amounts of genomic data are currently being generated and incorporated into a variety of health care systems¹ in the United States and abroad, and each instance presents a natural “experiment” offering the opportunity for learning about the integration of genomics into health care ecosystems. Of particular interest is genomic screening or genomics-based screening programs, referred to in the context of this workshop as clinical screening programs with the goal of examining genes or variants in unselected populations in order to identify individuals at risk for future disease or adverse drug outcomes for which there are clinical actions to mitigate risk. Many current genomics-based screening programs examine germline variability in specific genes that have been evaluated and recommended by groups such as the American College of Medical Genetics and Genomics, U.S. Preventive Services Task Force, or Evaluation of Genomics Applications in Practice and Prevention. There is potential strength in evaluating common outcomes of implementing these screening programs across multiple large health care systems and organizations that incorporate data from diverse population groups in order to

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¹ For the purposes of this workshop, health systems are referred to as entities providing medical care to a select population. Examples may include a for-profit or nonprofit health care delivery system or a public health system.

understand how genomics may or may not ultimately benefit all population groups. Tracking data from early implementers on the potential health benefits and harms of genomic screening programs may provide important evidence needed to assess the effectiveness and safety of genomic screening in unselected populations.²

AGENDA

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² The term population in the context of this workshop refers to individuals in the context of a health system that has implemented or is planning to implement a genomics-based screening program.

SESSION I: EVIDENCE CONSIDERATIONS FOR INTEGRATING GENOMICS-BASED PROGRAMS INTO HEALTH SYSTEMS

Session Objective:

• To examine the types of clinical data and other evidence that are currently being collected by genomics-based programs at health systems and to consider opportunities for advancing knowledge of clinical utility.

Key Questions:

• What evidence will your program generate, and how will it be useful in the future in terms of evaluating the value and utility of these activities?
• Are you currently sharing information from your genomics-based program or data across systems or organizations? How and with whom?
• What outcomes are important for genomics-based programs to measure? What potential impacts are there on care when deciding to invest in genomics-based programs?
• If you run into challenges such as a lack of evidence of utility or any harms (e.g., privacy, discrimination) to participants from implementing a genetic test in your program, how do you plan to track these outcomes and address them?

Session Moderator: George Isham, Senior Advisor, HealthPartners

SESSION II: FINANCIAL CONSIDERATIONS FOR IMPLEMENTING GENOMICS-BASED SCREENING PROGRAMS

Session Objectives:

• To discuss the financial considerations associated with genomics-based programs, including
  • Available models that can effectively evaluate genomics-based programs and the value they represent to their institution;
  • Approaches to measuring return on investment from implementation of genomics-based screening programs; and
  • Best practices for data sharing related to economic evaluations of genomics-based programs.

Key Questions:

• What business models are available to fund genomics-based screening programs? Would this program remain a priority for your organization if the current source of funding was no longer available? Is the program built to be sustainable? How?
• Are genomics-based programs affordable? Do they provide clinical utility or other value that can justify implementing the program? Beyond the cost of the genetic test itself, what are the downstream costs of care that need to be taken into account?
• How can institutions evaluate the opportunity costs associated with genomics implementation into a health system?
• Are there models that support data sharing between individual health care systems that are implementing genomics-based programs?
• What challenges do these programs create for clinical workflow?

Session Moderator: David Veenstra, Professor and Associate Director of Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle

SESSION III: CONSIDERING APPROACHES TO OPTIMIZE DATA SHARING AMONG EARLY IMPLEMENTERS OF GENOMICS-BASED PROGRAMS

Session Objective:

• To explore new ideas and opportunities for collaborative networks as a way for sharing economic and clinical outcome data about genomics-based programs between and within large-scale health care organizations.

Key Questions:

• How could data sharing across systems and organizations affect the measurement of value and clinical utility of genomics-based programs?
• Are there incentives for overcoming cultural and technological barriers to sharing data across systems and organizations? What are the incentives? If they do not exist, what is needed?
• What common outcomes or endpoints would be useful to collect from early implementers of genomics-based programs? What are the ideal data elements that should be collected from genomics-based programs?

Session Moderator: Marc Grodman, Assistant Professor of Clinical Medicine, Columbia University

SESSION IV: WORKING TOWARD THE NEEDS OF PARTICIPANTS AND IMPROVING DIVERSITY AND EQUITY

Session Objective:

• To consider policy issues associated with implementation of genomics-based programs in health systems and potentially in public health, including
  • Approaches to ensuring data security and participant privacy and
  • Methods for ensuring that genomics-based programs are accessible to a diverse group of participants.

Key Questions:

• Is this the right time to be studying use of genomic data and population health management in health systems? Why?
• How can genomics-based programs be designed in such a way to reach a diverse group of participants?
• How can genomics-based programs be equitably distributed regardless of educational status, income level, ethnicity, or other variables?
• If the early evidence indicates that genomics-based programs do not provide value and utility (and potentially demonstrate harms to participants), are the programs discontinued? How are they deimplemented and/or assessed again at a later date?

Session Moderator: Vence Bonham, Senior Advisor to the National Human Genome Research Institute Director on Genomics and Health Disparities, National Human Genome Research Institute, National Institutes of Health

SESSION V: NEXT STEPS TOWARD IMPROVING HEALTH THROUGH THE INTEGRATION OF GENOMICS-BASED PROGRAMS

Session Objectives:

• To discuss ideas for actionable next steps that could support the implementation of genomics-based programs in health systems.

• To consider infrastructure and resources that are needed to share data collected in clinical care across health systems for health outcomes and economics research.

Key Questions:

• Thinking about the workshop discussions today, what would be a game changer in terms of facilitating data sharing among early implementers of genomics-based programs?
• What next steps are critical for building an active learning model for outcome data on benefits, harms, and costs collected in genomics-based programs?

Session Moderator: W. Gregory Feero, Workshop Co-Chair, Faculty, Maine Dartmouth Family Medicine Residency Program

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