The NGS Institute: Advancing the Appropriate Use of Biomarker Testing

J Clin Pathways. 2023;9(1)30-31.

The NGS Institute acts as a trusted resource for curated, practical information on biomarker and next-generation sequencing (NGS) testing. Developed in partnership with the Journal of Clinical Pathways and contributed to by strategic partners and sponsors, the NGS Institute is structured around 3 pillars: Education and Information, Best Practices, and Research. These pillars support the institute’s mission “to promote education, research, and best practices in the use and reimbursement of companion, complementary, and continuity of care diagnostics, including biomarker, liquid biopsy, and [NGS] and comprehensive genomic profiling (CGP) testing.”

NGS testing is valuable as it plays a key role in helping clinicians identify patients with cancer early and determine what treatment will lead to the best results by identifying genomic mutations.¹ It contributes to better clinical outcomes by improving overall response rate, progression-free survival, and overall survival, and it increases sensitivity to new and emergent genomic mutations that can increase referrals to clinical trials. It is important to note that NGS testing itself does not increase total cost of care; the cost-of-care impact is primarily driven by increased utilization of more effective targeted medications and increases in patient survival. NGS testing also decreases the tissue needed for testing and reduces the need for repeat biopsies compared to multiple conventional single-gene assays and non-CGP NGS-based hotspot testing.¹

With all of this in mind, the NGS Institute is focused on creating principles for payment, identifying barriers, and suggesting solutions to collaborate efforts with all stakeholders. It intends to act as a reference for existing standards and approaches to identify best practices. However, it is not trying to set new standards for biomarker testing or to relitigate the science, nor does it recommend one vendor over another.

The executive committee is charged with setting the NGS Institute’s direction, mission, charter, priorities, and values. Members of the executive committee include:

• Gordon Kuntz – President and Consulting Partner, Kuntz Consulting
• Ira Klein, MD, MPP, FACP – Vice President, Medical Affairs & Payer Relations at Tempus Labs
• Kashyap Patel, MD – President of Community Oncology Alliance and CEO of Carolina Blood and Cancer Care Associates
• Blase Polite, MD, MPP, FASCO – Associate Professor of Medicine; Deputy Section Chief for Clinical Operations and Executive Medical Director for Cancer Accountable Care at the University of Chicago

The charter of the NGS Institute is to:

• Curate educational and background materials for multiple stakeholders, including payers, employers, practices, physicians, and patients;
• Develop transparent, consensus-based, patient-centric best practices in biomarker and NGS testing in collaboration with payers, employers, physicians/practices, testing companies, and patient advocacy groups;
• The intent of the best practices is to influence and align payment and administrative policies among payers and employers through principles for payment that address standards for ordering testing, use of test results in treatment selection, and frequency of testing;
• Sponsor research to promote the appropriate use of biomarker and NGS testing; and
• Ensure that oncologists and patients have the best information available about the full range of effective treatment options, including clinical trials, for every patient.

One of the ways the NGS Institute fulfills its mission and charter is by developing consensus guidance for the use and coverage of NGS testing in select tumor types. These guidelines are generated for the institute by health care providers, payers, and other key stakeholders. In addition, the NGS Institute also conducts original research on the economic and clinical impact of NGS testing, as well as academic exchanges on areas for future research opportunities.

An example of this process at work is in the non–small cell lung cancer (NSCLC) space. Over the past 10 years, tissue and/or blood biomarkers have helped guide treatment decisions of patients who have advanced NSCLC.² There are multiple biomarker-defined patient subgroups, and evidence indicates that targeted therapies provide superior clinical outcomes when compared with traditional cytotoxic chemotherapy.² However, rapid changes in precision oncology make it challenging to translate recommendations into clinical practice.²

Genotyping and CGP represent the first step toward personalizing treatment of NSCLC. Recent technology advances in multiplex genotyping and genomic profiling by NGS technologies help us to better understand the cancer genome quickly.  This advance helps identify molecularly defined subsets of patients with NSCLC for whom a growing list of novel molecularly targeted therapies are clinically valuable.³

At many medical centers, using NGS cancer panels to guide treatment is no longer considered experimental and is a part of routine clinical practice.⁴ Genomic data can help identify targeted therapies and inform patient selection for clinical trials, such as the National Cancer Institute–Molecular Analysis for Therapy Choice or Lung-MAP trials.⁴ Furthermore, professional guidelines, such as the National Comprehensive Cancer Network guidelines for NSCLC, cutaneous melanoma, and colon and rectal cancer, recommend molecular profiling to direct appropriate clinical care.⁴

To focus on best practices in payment policies for NSCLC in particular, the NGS Institute recruited a subcommittee of experts in the NSCLC space.  This lung cancer subcommittee includes:

• Ira Klein, MD, MBA, FACP – Vice President, Medical Affairs & Payer Relations at Tempus Labs
• Winston Wong – President of the W-Squared Group
• Mark Socinski, MD – Executive Medical Director of the AdventHealth Cancer Institute, Orlando, Florida, and a member of the Institute’s Thoracic Oncology Program
• Nikki Martin – Senior Director of Precision Medicine Initiatives, LUNGevity
• Edward Licitra, MD, PhD – Chairman and Chief Executive Officer of Astera Health Partners. Board of Directors of OneOncology and Community Oncology Alliance and is on the ION Advisory Board
• Chris Skisak, PhD – Executive Director of the Houston Business Coalition on Health
• Bryan Loy, MD, MBA – Medical Director, Humana
• Ben Jones – Vice President of Government Relations & Public Policy for the McKesson specialty provider organization and The US Oncology Network

The NGS Institute acknowledges that there are challenges in adopting NGS testing in NSCLC and beyond. Payers may be concerned about the cost, quality, and use of results, which may be the source of inconsistent and outdated payer policies. Provider concerns may include operational challenges due to inconsistent payer policies, slow results, and a lack of knowledge.  Then, patients may find issues with the timing of the results, and they may simply not know much about NGS testing.

There are many benefits in the clinical utilization and reimbursement for expanded genomic panel testing in adult oncology. Molecular tumor profiling using large NGS-based cancer panels provides therapeutic options as well as mechanistic insights into tumor biology, pathogenesis, and prognosis.⁴ Integrating genomic-level decision-making into patient care is key to delivering on the promise of personalized medicine, and the NGS Institute aims to play a role in facilitating this process.