The Patient Protection and Affordable Care Act authorizes PCORI as a non-profit corporation to assist patients, clinicians, purchasers, and policymakers in making informed health decisions by providing quality, relevant evidence on how best to prevent, diagnose, treat, and monitor diseases and other health conditions. Before it can do so, however, it needs to build a consensus on methodologies that will bind researchers and analysts to a common structural approach in furnishing the required evidence to its stakeholder communities. Hence the designation of the Methodology Committee represents an important milestone for PCORI in ensuring the $1.1 billion in research funding initially authorized under the federal stimulus legislation will be well spent—or at least minimally understood by the intended users of the evidence.

The 15 members selected are well known to the inbred community of professional practice experts and academics that tend to dominate the discussion on value in medicine.  Significantly, only one payer organization is represented on the group – from the major non-profitl Blue Cross/Blue Shield.  And predictably, no one from the industries whose medicines and diagnostics will eventually be evaluated by PCORI through the guidelines process is represented due to conflict of interest issues. Nevertheless, a few prominent critics of QALYs and other rigid comparative effectiveness assessment tools linked to rationing in markets outside the US are included in the group, most notably Professor David Meltzer of the University of Chicago.

Professor John Ioannidis of Stanford University is in many ways a surprising choice as well, given his reputation as a critic of the utility of most such research, which he contends is undermined by patient selection bias, poor study profiling, late compilation of findings, and other inherent design flaws. Most research is usually simply overtaken by events or the march of medical progress, which results in few such studies being able to stand the test of time.

The 15 new members are:

o    Naomi Aronson, PhD, Executive Director, Blue Cross and Blue Shield Association Technology Evaluation Center.
o    Ethan Basch, MD, MSc, medical oncologist and health services researcher, Department of Medicine and Department of Epidemiology, Memorial Sloan-Kettering Cancer Center.
o    Alfred Berg, MD, MPH, Professor, Department of Family Medicine, University of Washington.
o    David Flum, MD, MPH, Professor, Department of Surgery and Adjunct Professor, Department of Health Services, University of Washington Schools of Medicine and Public Health; Attending physician, General Surgery, University of Washington Medical Center.
o    Sherine Gabriel, MD, MSc, Professor of Medicine and of Epidemiology, and the William J. and Charles H. Mayo Professor, Mayo Clinic.
o    Steven Goodman, MD, PhD, Professor of Oncology, of Pediatrics, of Epidemiology and of Biostatistics, Johns Hopkins School of Medicine and Bloomberg School of Public Health.
o    Mark Helfand, MD, MS, MPH, Professor of Medicine and of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University; Staff physician, Portland VA Medical Center.
o    John Ioannidis, MD, DSc, the C.F. Rehnborg Professor in Disease Prevention, Professor of Medicine and Director, Stanford Prevention Research Center, Stanford University School of Medicine.
o    David Meltzer, MD, PhD, Director, Center for Health and the Social Sciences, Chief of the Section of Hospital Medicine, and Associate Professor, Department of Medicine, Department of Economics, and Graduate School of Public Policy Studies, University of Chicago.
o    Brian Mittman, PhD, Director, VA Center for Implementation Practice and Research Support, Department of Veterans Affairs Greater Los Angeles Healthcare System.
o    Robin Newhouse, PhD, RN, Assistant Dean, Doctor of Nursing Practice Program and Associate Professor, Organizational Systems and Adult Health, University of Maryland School of Nursing.
o    Sharon-Lise Normand, MSc, PhD, Professor of Health Care Policy, Harvard Medical School and Professor of Biostatistics, Harvard School of Public Health.
o    Sebastian Schneeweiss, MD, ScD, Associate Professor, Department of Medicine, Harvard Medical School and Associate Professor, Department of Epidemiology, Harvard School of Public Health; Vice Chief and Director, Drug Evaluation and Outcomes Research, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.
o    Mary Tinetti, MD, Professor of Medicine, Epidemiology, and Public Health, Division of Geriatrics, Yale University School of Medicine; Director, Program on Aging, Yale University School of Medicine.
o    Clyde Yancy, MD, MSc, Chief, Cardiology, Northwestern University Feinberg School of Medicine; Associate Director, The Bluhm Cardiovascular Institute, Northwestern Memorial Hospital.

In addition to these 15 members, the Director of the Agency for Healthcare Research and Quality and the Director of the National Institutes of Health, or their designees, will also serve on the committee. If anything, this will ensure some basic “political minding” to ensure the group stays out of trouble with Congress and the “death panel” crowd.

As is always the case with health care economics, the technocrats will carry the strongest voice. But where is the patient?

The mere mention of the term “comparative effectiveness” evokes a host of reactions among pharmaceutical manufacturers: confusion, skepticism, even fear. With President Obama calling for a national agency for comparative effectiveness, no one doubts that it is coming to healthcare—but what will it encompass? How will comparative effectiveness impact access to medications? What can manufacturers do to prepare?

Join us on Thursday, June 25 at 2:00 PM (EDT), as Tommy Bramley, senior director for Xcenda, and Tracy Foster, president for Lash Group, present insights that address:

• An overview of comparative effectiveness and an update of its
  progress at the federal level
• Perspectives about comparative effectiveness from managed
  care stakeholders
• How manufacturers can evaluate their risk and prepare for additional
  requests for comparative analysis data
• What manufacturers can do to ensure continued patient access
  to products
• How manufacturers can validate ongoing clinical and economic
  benefits for their products

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