— Multi-stakeholder effort defines framework for determining coverage and presents corresponding research study design recommendations —
Boston, Mass., December 12, 2012 – The Institute for Clinical and Economic Review (ICER), an academic health policy group based at the Massachusetts General Hospital Institute for Technology Assessment, has released a comprehensive white paper entitled “ Diagnostic Tests for Alzheimer’s Disease: Generating and Evaluating Evidence to Inform Insurance Coverage Policy.”  The report was developed in conjunction with a multi-stakeholder group of leading insurers, clinical researchers, life science companies, and patient organizations, and will be the subject of a presentation at the January 30, 2013 meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC).  
“This white paper is an important landmark,” stated Reisa A. Sperling, MD, MMSc, Professor of Neurology at Harvard Medical School, and a member of the ICER Policy Development Group on the report.  “Diagnostic testing for Alzheimer’s disease is an area of rapid innovation, but there is no easy consensus on what kinds of studies need to be done to provide evidence that is ‘good enough’ to guide practice and to inform insurance coverage decisions.  That’s why it’s so important to have an open dialogue between researchers, patients, clinicians, life science companies, and insurers.   The white paper represents the fruit of this dialogue and helps to chart the way forward.  I think this effort has produced important learning on all sides and will help the broader research community and insurers work together more effectively toward a common purpose of generating robust evidence on emerging diagnostic approaches to Alzheimer’s disease.”  
The report surveys the existing literature on diagnostic tests and presents the conceptual framework used by technology assessment groups and insurers to evaluate the evidence on new diagnostic approaches in Alzheimer’s disease.  Building from this analysis, the report goes on to present specific recommendations on how to design research studies that will be able to generate the kind of robust evidence needed to guide clinical practice and insurance coverage policies.  Among the specific recommendations, the research community is encouraged to measure not only the technical accuracy of diagnostic tests but whether they have an actual impact on subsequent clinical decisions and patient outcomes.  Methods for embedding evaluations of potential biomarker tests within therapeutic trials are discussed, and steps to link biomarker results to patient-centered outcomes are presented.  
“Reviews of evidence on new diagnostic tests in many fields often identify key evidence gaps that limit the ability to understand the true impact of testing on patient outcomes,” stated Steven D. Pearson, MD, MSc, FRCP, President of ICER.  “And these evidence gaps leave patients, clinicians, and insurers not knowing whether the tests should or should not be widely used.  What we sought to do with this report is to flip this usual dynamic into a pro-active, future-oriented perspective.  What kind of evidence is needed to meet insurer standards for coverage?  What steps can be taken today to build the studies that will help generate the kind of evidence that will be viewed as persuasive?  That was our goal, and it could only come out of a process that included the perspectives of all the key stakeholders in Alzheimer’s research.”
The white paper is publicly available on the ICER website.
About ICER
The Institute for Clinical and Economic Review (ICER), based at the Massachusetts General Hospital’s Institute for Technology Assessment (ITA) and an affiliate of Harvard Medical School, provides independent evaluation of the clinical effectiveness and comparative value of new and emerging technologies. ICER seeks to achieve its ultimate mission of informing public policy and spurring innovation in the use of evidence to improve the value of health care for all.  For more information, please visit www.icer-review.org