Lawrenceville, NJ, USA—September 27, 2022—Value & Outcomes Spotlight, the health economics and outcomes research (HEOR) news magazine of ISPOR—The Professional Society for Health Economics and Outcomes Research, announced today the publication of a supplement, “A Plan of Action: Accelerating Patient Access to Next-Generation Sequencing in Oncology,” that details the challenges in improving patient access to next-generation DNA sequencing and proposes a plan of action to improve access.
Next-generation sequencing (NGS)—a form of DNA sequencing that can examine millions of DNA molecules simultaneously—is the key to precision medicine in oncology. Through such advanced sequencing, the genomic and genetic profile of a patient with cancer can be assessed, which can then be used to help guide patients to the most suitable therapies. NGS delivers several benefits across the patient care pathway, from providing patients with a tailored therapeutic strategy to increasing efficiency in healthcare systems delivery of care, resulting in potential cost savings and benefits to future patients. Despite the significant clinical and economic benefits that NGS could deliver, there are barriers impeding the broader uptake of NGS in clinical practice.
In May 2022, ISPOR brought together several leading experts to discuss the benefits of NGS, the significance of the barriers in preventing patient access to NGS today, and what potential policy solutions could address these barriers. The panelists highlighted that for patients to benefit from the advances of NGS, there is a need for action across several domains, including the diagnostic governance framework, the approach to funding and reimbursement, and improved education on NGS. Although the specifics of the NGS access challenges can vary from region to region and country to country, a change in the access paradigm will require stakeholders (ie, payers, policy makers, patients, clinicians/providers, and manufacturers of diagnostics and treatments) to work together. The Value & Outcomes Spotlight supplement is a follow-up to the 2022 expert panel and open webinar, both of which were supported by Merck Sharp & Dohme LLC, known as MSD outside of the United States and Canada.
In an introductory editorial to the supplement, “Next-Generation Sequencing: New Paradigm, Same Evidence Required?,” Lieven J.P. Annemans, PhD, Ghent University, Belgium, acknowledges the challenges in improving patient access to next-generation sequencing but emphasizes the need for clear direction and consensus regarding the types and level of evidence required to allow market access to this technology to the benefit patients. “To make progress in this field on what evidence is required,” said Annemans, “the diagnostics and pharmaceutical industry needs to start dialogues with payers and HTA bodies in order to arrive at a clear and broadly applied consensus about how much and which type of evidence is required to allow market access to the benefit of the patients.”
The supplement’s core article, “Accelerating Patient Access to Next-Generation Sequencing in Oncology: A Plan of Action,” begins by reviewing the benefits of NGS testing to patients, healthcare systems, payers, and society, then pivots to 3 key barriers hindering access to NGS testing in oncology: (1) the overall NGS policy environment and existing infrastructure, (2) public funding regime and health technology assessment for NGS testing, and (3) stakeholder awareness.
With these barriers in mind, the authors note that while there are a wide range of potentially important policies that would support access to NGS, there are 3 policy initiatives that could be prioritized:
- Establishing an effective governance framework for NGS
- Optimizing approaches and frameworks used to assess the value of NGS and the allocation of funding
- Taking political action to create a strategic framework that addresses the different aspects of funding, education, and implementational and legal considerations, and involves all stakeholders, including policy makers, clinicians, payers, and patients
“Clinical practice is shifting toward an era of precision medicine,” the authors wrote. “The use of genomic profiling of patients with technologies such as NGS has the potential to support the selection of therapies on a much larger scale than it is currently and has the potential to improve health outcomes while using healthcare resources more efficiently. Given the nature of NGS technology and the broad barriers that it faces, there is agreement that holistic policy intervention will be needed.”
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Value & Outcomes Spotlight is ISPOR’s bimonthly news publication for the global HEOR community that provides feature articles on timely HEOR topics, methodological and health policy articles, as well as updates from ISPOR leadership and news from around the world.
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