ISPOR PERSONALIZED / PRECISION MEDICINE SPECIAL INTEREST GROUP
Precision Medicine: Assessing the Value Working Group
Co-Chairs:
Fadia T. Shaya, PhD, MPH
Professor, Vice-Chair, Director of Research,
University of Maryland School of Pharmacy & Medicine,
Baltimore, USA
Katherine Payne, PhD, MSc
Professor of Health Economics, Manchester Centre for Health Economics, Institute of Population Health, University of Manchester
Manchester, UK
Leadership Group:

Bhagwan Aggarwal, PhD, MBA, MSc, BSc, Mphil, Assistant Director, NIOH/ICMR, India
Charles Barr, PhD, MD, MPH, Head of Evidence Science & Innovation, Genentech, USA
Eman Biltaji, MS, BSc, Graduate Student/ Research Assistant, University of Utah, Pharmacotherapy Outcomes Research Center, USA
Diana Brixner, PhD, RPh, Professor, University of Utah, College of Pharmacy, USA
Vivek Chaudhari, MS, Graduate Research Assistant, University of the Sciences in Philadelphia, USA
Eric Faulkner, MPH, Vice President, Precision and Transformative Technology Solutions, Value Demonstration, Access and Commercial, Evidera; Assistant Professor, Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina at Chapel Hill, USA
Anke-Peggy Holtorf, PhD, MBA, Managing Director, Health Outcomes Strategies, GmbH, Switzerland
Maarten Ijzerman, PhD, MSc, Professor, Chair, Department of Health Technology & Services Research, University of Twente, the Netherlands
James Jackson, PharmD, MPH, Vice President, Xcenda, LLC., USA
Wee Hwee Lin, Assistant Professor, Department of Pharmacy, Faculty of Science, National University of Singapore  
Emelline Liu, MSPH, Health Economist, Cepheid, USA
Christine Lu, PhD, MSc, Associate Professor of Population Medicine & Co-Director of PRecisiOn Medicine Translational Research Center (PROMoTeR), Harvard Medical School and Harvard Pilgrim Health Care Institute, USA
Jennifer Oberg, MA, EdD, Assistant Professor, Columbia University, USA
Silvia Paz, MD, Associate Director, Outcomesâ´10, Spain
Gurmit Sandhu, MBA, MPH, Patient Advocacy Specialist, GS Consulting, GmbH, Switzerland
Uwe Siebert, MD, MPH, MSc, ScD, Professor of Public Health, UMIT - University for Health Sciences, Medical Informatics and Technology, Austria
Susan Snyder, PhD, BS, MBA, Research Investigator / Health Economist, Geisinger Center for Health Research, USA
Simran K. Tiwana, MBA, PhD, Senior Manager, Health Technology Assessment Center of Excellence, Global Health Economics, Amgen Inc., USA
Surrey Walton, PhD, Associate Professor, UIC, USA
John Watkins, PharmD, MPH, Pharmacy Manager, Formulary Development, Premera Blue Cross, USA

Objective:
  • Provide a definition of the three key terms used: precision medicine, personalized medicine, and stratified medicine
  • Describe the role of health economic and outcomes research (HEOR) in the context of providing an evidence base to support the use of precision medicine
  • Identify key research recommendations for applied research and methodological developments to provide an evidence base to support the use of precision medicine
Background:

There are many global initiatives that are promoting the use of precision (or personalized) medicine with the suggested advantages of significant potential added value to drug development and health care delivery for the benefit of patients. However these initiatives may also change the paradigm of how health care is delivered and also how added value is quantified. From genomics to patient centered care, payers, health systems and government will have to consider new approaches in making coverage and payment decisions, while targeting medical interventions for specific patients. The developing field of precision medicine presents an opportunity and a challenge for pharmacoeconomics/health economic and outcomes research.

Outline:
  1. Terminology and scope of this paper
    1. What are the different terms for the topic (Precision/Personalized/Stratified)
      1. Stakeholder, geographic regions, disciplines 
      2. How are they uses, are these harmful, or helpful to different stakeholders
  1. What terminologies are helpful and for what discipline
    1. Table format
    2. Propose taxonomy of terms
    3. Appreciate difference between terms
  1. How are different stakeholders reacting to the new 'movement' of PM?
    1. Why is it important for ViH readers and HEOR,
  1. What are the tools of PM?
    1. (Genomics, social sciences, PCOR)
    2. Tools sporadic/random
      1. Extent to which tools are utilized in Real World Practice
      2. Correct terminology with tools
  1. Discussion
    1. Current Role of HEOR in PM
    2. Proposed framework for future research in PM
      1. Role of PM in Evidence-Based Medicine
    3. “Macro” vs “Micro” evidence?
    4. Defining “clinical utility” at a personal level
  2. Future Role of PM in HEOR
Work Product:

A manuscript for Value in Health: Being precise about precision medicine: What is it and how should we assess its added value?

Activities:

Are Payers Equipped to Assess the Unique Value of Precision and Personalized Medicine (PPM)? Analyzing Current Value Frameworks and their Application within the PPM Context
May 22, 2017 – ISPOR 22nd Annual International Meeting, Workshop Presentation, Boston, MA, USA

Generating Evidence of the Added Value of 'Precision’ Medicine
October 31, 2016 – 19th Annual European Congress, Forum Presentation, Vienna, Austria

Precision Medicine: The End of Outcomes Research?
May 24, 2016 – 21st International Meeting, Issue Panel Presentation, Washington, DC., USA

Work product timeline:
Activity Date

SIG project initiated

May 2015

Members solicited to work on manuscript

May – November 2015

Refine and develop detailed outline through discussion of issues via teleconference September 2015 – February 2016
Abstract submitted for ISPOR meeting January 2016
Assign sections of the manuscript to the SIG leadership members February 2016

Develop manuscript sections

February – November 2016

Revisions and preparation for Issue Panel presentation

April 2016

Presentation at ISPOR Annual International Meeting May 25, 2016
Preparation for Forum presentation at ISPOR Annual European Congress September – October 2016
Draft manuscript sent to ISPOR SIG Review Group
(members interested in the topic)
December 2016
Manuscript revised based on comments received at presentation and
from membership review
January 2017
Revisions and 2nd review by ISPOR SIG Review Group February 2017
Comments reviewed and discussed March 2017
Authors revise sections April 2017
Members and chair finalize and sign off on final report May 2017
Manuscript submitted to Value in Health May 2017

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