September 9, 2013
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.