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Press Releases

September 9, 2013

How Will Next Gen Sequencing Tests be Evaluated by Payers?
While molecular diagnostics offer tremendous promise for improving health and offsetting costs in the oncology setting, the benefits and harms of testing are often not well known in terms that are meaningful to stakeholders. Tests are often presumed to offer clinical benefits, and may even be taken up into clinical practice based on that assumption. 
Yet, systematic reviews have noted the lack of sufficient evidence for many of these molecular diagnostic tests, and called for more and higher quality studies to demonstrate analytic and clinical validity as well as clinical utility. Although the calls for better evidence are frequent, there is considerable debate about how much evidence is needed and how it can be generated in an efficient and timely way.

In her presentation at the 5th Annual Personalized Medicine Conference, Dr. Patricia Deverka will discuss the (CMTP) Center for Medical Technology Policy’s recently released Effectiveness Guidance Document (EGD) on molecular diagnostics. The purpose of this EGD is to close the gap between the presumed benefits of tests undergoing technology assessments and the information needs of payers, clinicians and patients. The EGD recommendations were created through an iterative process that incorporated the perspectives of major stakeholder groups, including researchers, clinicians, payers, industry, guideline developers and patient advocates.

Dr. Deverka will summarize the lessons learned from this 3-year multi-stakeholder project on molecular diagnostics. She will describe the unique features of NGS tests (primarily from a reimbursement perspective); outline the methods challenges, and discuss how they plan on approaching a follow-on project to develop methods guidance to demonstrate the clinical utility of NGS tests, using a multi-stakeholder approach.

The EGD is designed to create a common framework for evidence, so that test developers and researchers can anticipate reimbursement and clinical evidence expectations and plan studies appropriately. Additionally, payers and technology assessors can use the same standards for evaluating study results. In this way, if used consistently, the EGD will bring greater clarity and predictability regarding the evidence requirements of post-regulatory stakeholders.

The 5th annual Personalized Medicine Conference will explore the ways in which personalized Medicine is beginning to reshape healthcare. It will be held on October 21 -22, 2013 in Boston. The event is an official satellite event of the American Society for Human Genetics Annual Meeting. Please visit: www.personalized-medicine-conference.com for more information.

Source: http://www.cmtpnet.org/effectiveness-guidance-documents/molecular-diagnostics-egd/

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