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October 26, 2020
JAMA Publication by GEECS Finds Global Use and Funding of Clinical Genomic Sequencing Expands but More Data on Implementation Are Needed

A key challenge for the appropriate implementation of precision medicine is the need to evaluate its costs, benefits, and risks. However, several issues arise when measuring the value of precision medicine, particularly new genomic tests that measure multiple rather than single genes, often using next-generation sequencing (NGS) technologies. In the last few years, there has been an emerging consensus that conventional methods to assess utility and value are not well suited for evaluating the value of genomic testing.​

May 8, 2020
Set of Papers in Value In Health Address Methods for Moving Evaluation of Precision Medicine into Practice and Policy

A key challenge for the appropriate implementation of precision medicine is the need to evaluate its costs, benefits, and risks. However, several issues arise when measuring the value of precision medicine, particularly new genomic tests that measure multiple rather than single genes, often using next-generation sequencing (NGS) technologies. In the last few years, there has been an emerging consensus that conventional methods to assess utility and value are not well suited for evaluating the value of genomic testing.

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To address these issues, we published six papers in a special theme section in Value in Health specifically focused on evaluation methods for moving precision medicine into practice and policy. This special theme section features five papers from the Global Economics and Evaluation of Clinical Genomics Sequencing Working Group (GEECS) and one paper by the ISPOR Special Interest Group on Precision Medicine and Advanced Therapies. The work was chaired by Kathryn A. Phillips, PhD, and her introduction lays out the context and findings of the papers.

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The papers form a common theme of describing methods of evaluation of sequencing technologies using different approaches and perspectives to facilitate the adoption of the technology when appropriate. They incorporate a wide range of perspectives and topics and use simulation models, medical record reviews, systematic reviews, interviews, payer coverage policy analysis, and case examples. The findings and recommendations are intended not only for health economic researchers but also for other stakeholders including health technology assessment organizations, payers, clinical researchers, and the biotechnology and pharmaceutical industries. Key takeaways from these articles are:

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  • Much progress has been made in developing and applying methods to evaluate precision medicine. However, new tests such as minimally invasive liquid biopsies and emerging approaches such as artificial intelligence and machine learning platforms will continue to require the development and adaptation of methods used to assess the value of precision medicine, which are discussed in this set of papers. (Phillips)

  • It is important to define the core factors that should be considered in a value assessment framework for precision medicine with multiple perspectives obtained by building consensus among stakeholders for robust procedures and measures of value aspects. (Faulkner et al)

  • Improving the use of Real World Evidence for payer decision-making involves multiple strategies to overcome the data, methodologic and policy challenges, which can be advanced by coordinating with stakeholders to develop robust RWE that can be incorporated into assessments of NGS value. (Deverka et al)

  • The use of temporal analyses to assess payer coverage policy for Next-Generation Tumor Sequencing (NGTS) by private U.S. payers reveals important trends in coverage decision and informs economic and affordability assessments. (Trosman et al)

  • Different methods for identifying healthcare utilization attributable to unanticipated genomic results from newborn genomic sequencing are needed to assess follow-up care. (MacKay et al)  

  • The use of simulation modeling to provide potential solutions and approaches to dealing with complexities of the economic evaluation of precision medicine. (Marshall et al)

September 14, 2018
Value In Health issue addresses challenges and solutions for assessment of the value of clinical genomic testing

Over the last decade, genetic testing to inform precision medicine has evolved from the use of single-gene tests to more complex tests that measure multiple genes, the entire exome (coding region of the genome) or the entire genome using next-generation sequencing (NGS) technology. As the cost of NGS technology has decreased and NGS-based tests are increasingly being incorporated into clinical patient care, health insurance companies, health technology assessment organizations, and governments must assess the clinical and economic value of NGS-based tests. In the last few years, there has been an emerging consensus that conventional frameworks used by payers to assess the value of new drugs are not well suited for evaluating the value of genomic testing.

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This special theme section of the September 2018 issue of Value in Health specifically focuses on assessing the value of NGS-based clinical testing. While it’s critical to assess the value of NGS, there are many methodological challenges to doing so. This series of expert articles push the envelope by not only highlighting the challenges, but by suggesting innovative solutions to move the value assessment process forward for precision medicine. The papers incorporate a wide range of perspectives and topics and use both systematic reviews and case studies – but they all focus on the overarching issue of proposing new methodologies to assess the value of NGS-based technologies in clinical care. The proposals included are not intended only for health economic researchers, but also to other stakeholders including health technology assessment organizations, payers, clinical researchers, and the biotechnology and pharmaceutical industries.

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  • Key Takeaways from this special theme section articles are: There are several important methodological challenges to measuring the value and economic impact of NGS in clinical care that should be prioritized for research and innovative solutions. (Phillips et al) 

  • Real-world performance-based risk sharing arrangements (PBRSAs), where reimbursement for certain genomic testing is contingent on meeting specific real-world clinical or economic metrics—represent the most promising innovative framework for addressing the important features of NGS testing. (Trosman et al) 

  • “Big data” from population-level genomics initiatives (e.g., the UK 100,000 Genomes Project) could be a rich source of evidence for cost effectiveness analyses; however, practical and methodological challenges should be addressed early in the design of these initiatives through collaboration with health economists. (Wordsworth et al) 

  • Best practices for ongoing and future economic analyses of genomics are emerging, including addressing the challenges of developing an appropriate comparator, capturing appropriate downstream costs, and documenting impact on health-related quality of life. (Christensen et al) 

  • Existing health technology assessment (HTA) methods do not fully capture the potential value of NGS; future research and value assessment should include both health and non-health outcomes. (Regier et al)

February 10, 2017
Value In Health features GEECS papers and commentary on assessing the value of precision medicine and other Big Data technologies

The world has entered the "Information Age" for health care. In this world, everything is connected and the integration of "Big Data" - characterized by high velocity, volume, and variety - is increasingly important. Yet this growth in technologies must be integrated into a health care system that is undergoing fundamental change. A commentary and series of papers by GEECS collaborators and other authors (organized by GEECS Chair Director Kathryn Phillips) offers insights into these trends and their implications for assessing value. The papers incorporate a wide range of perspectives - patients, providers, health care systems, society - but they all focus on the overarching issue of how to appropriately consider and assess the value of new technologies.

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