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Suggested Citation:"Front Matter." Institute of Medicine. 2009. Assessing and Improving Value in Cancer Care: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12644.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Adam Schickedanz, Rapporteur National Cancer Policy Forum Board on Health Care Services

THE NATIONAL ACADEMIES PRESS  500 Fifth Street, N.W.  Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This study was supported by Contract Nos. HHSN261200611002C, 200-2005-13434 TO #1, and 223-01-2460 to #27, between the National Academy of Sciences and the National Cancer Institute, the Centers for Disease Control and Prevention, and the Food and Drug Administration, respectively. This study was also supported by the American Cancer Society, the American Society of Clinical Oncology, the Association of American Cancer Institutes, and C-Change. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13:  978-0-309-13814-7 International Standard Book Number-10:  0-309-13814-0 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC, 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2009 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2009. Assessing and improving value in cancer care: Workshop summary. Washington, DC: The National Academies Press.

“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health.

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a man- date that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

PLANNING COMMITTEE ON ASSESSING AND IMPROVING VALUE IN CANCER CARE Scott D. Ramsey (Chair), Full Member, Fred Hutchinson Cancer Research Center Peter Bach, Associate Member, Memorial Sloan-Kettering Cancer Center Thomas Burish, Past Chair, American Cancer Society Board, and Provost, Notre Dame University Robert L. Erwin, President, Marti Nelson Cancer Foundation Betty Ferrell, Research Scientist, City of Hope National Medical Center Patricia Ganz, Director, Division of Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center, UCLA Allen Lichter, Executive Vice President and Chief Executive O ­ fficer, American Society of Clinical Oncology Harold L. Moses, Director Emeritus, Vanderbilt-Ingram Cancer Center Sean Tunis, Founder and Director, Center for Medical Technology Policy Project Staff Roger Herdman, Project Director, National Cancer Policy Forum and Board on Health Care Services Adam Schickedanz, Christine Mirzayan Science and T ­ echnology Policy Graduate Fellow Michael Park, Senior Program Assistant Ashley McWilliams, Senior Program Assistant Laura Levit, Program Officer Christine Micheel, Program Officer 

NATIONAL CANCER POLICY FORUM Harold Moses (Chair), Director Emeritus, Vanderbilt-Ingram Cancer Center Fred Appelbaum, Director, Clinical Research Division, Fred Hutchinson Cancer Research Center Peter Bach, Associate Attending Physician, Memorial Sloan- K ­ ettering Cancer Center Edward Benz, Jr., President, Dana Farber Cancer Institute and Director, Harvard Cancer Center Thomas Burish, Past Chair, American Cancer Society Board of Directors and Provost, Notre Dame University Michaele Chamblee Christian, Division of Cancer Treatment and Diagnosis, National Cancer Institute Robert Erwin, President, Marti Nelson Cancer Foundation Betty Ferrell, Research Scientist, City of Hope National ­Medical Center Joseph Fraumeni, Jr., Director, Division of Cancer ­Epidemiology and Genetics, National Cancer Institute Patricia Ganz, Professor, UCLA Schools of Medicine & Public Health, Jonsson Comprehensive Cancer Center Robert German, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention Roy Herbst, Chief, Thoracic/Head & Neck Medical Oncology, M.D. Anderson Cancer Center Thomas Kean, Executive Director, C-Change John Mendelsohn, President, M.D. Anderson Cancer Center John Niederhuber, Director, National Cancer Institute  Institute of Medicine forums and roundtables do not issue, review, or approve indi- vidual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. The Institute of Medicine (IOM) established the National Cancer Policy Forum (NCPF), effective on May 1, 2005, to succeed the National Cancer Policy Board (NCPB), which existed from 1996 to 2005. IOM forums are designed to allow government, industry, academic, and other representatives to meet and confer privately on subject areas of mutual interest. NCPF is the successor to the NCPB in providing a focus within the National Academies for the consideration of issues in science, clinical medicine, public health, and public policy relevant to the goals of preventing, palliating, and curing cancer. vi

David Parkinson, President and CEO, Oncology Research and Development, Nodality, Inc. Scott Ramsey, Full Member, Cancer Prevention Program, Division of Public Health Science, Fred Hutchinson Cancer Research Center John Wagner, Full Member, Executive Director, Clinical P ­ harmacology, Merck and Company, Inc. Janet Woodcock, Deputy Commissioner and Chief Medical O ­ fficer, Food and Drug Administration Staff Roger Herdman, Director, National Cancer Policy Forum and Board on Health Care Services Erin Balogh, Research Associate Laura Levit, Program Officer Ashley McWilliams, Senior Program Assistant Christine Micheel, Program Officer Sharyl Nass, Senior Program Officer Michael Park, Senior Program Assistant Adam Schickedanz, Christine Mirzayan Science and Technology Policy Graduate Fellow Ania Woloszynska-Read, Christine Mirzayan Science and T ­ echnology Policy Graduate Fellow vii

Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report: Craig Earle, Cancer Care Ontario and Ontario Institute for Cancer Research Patricia Ganz, UCLA Schools of Medicine & Public Health, Jonsson Comprehensive Cancer Center Allen Lichter, American Society of Clinical Oncology Steve Phurrough, Center for Medicare and Medicaid Services Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by ix

 REVIEWERS Sharon Murphy. Appointed by the Institute of Medicine, she was respon- sible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the rapporteur and the institution.

Contents PREFACE xv 1 INTRODUCTION 1 2 OPENING REMARKS: What Is Value in Cancer Care and Why Is It Important? 3 PART I: CHALLENGES TO VALUE IN CANCER CARE 3 CLINICIAN–PATIENT COMMUNICATION AND ITS INFLUENCE ON VALUE 9 Inside the Physician–Patient Discussion in Cancer Care, 9 Therapy for Advanced-Stage Cancer: What Do Patients Want and Expect?, 17 Discussion, 19 4 GENERATING EVIDENCE ABOUT EFFECTIVENESS AND VALUE 23 The FDA and Evidence for Regulatory Approval in Cancer, 23 What Constitutes Reasonable Evidence of Efficacy and Effectiveness in Cancer Care?, 27 Discussion, 31 xi

xii CONTENTS 5 VALUE AND THE ONCOLOGY MARKET 33 Drug Pricing and Value in Oncology Compared to Other Areas in Medicine, 33 Industry Perspective on Pharmaceutical Pricing in Oncology, 39 Building the Evidence Base for Value of New Treatments: Cost-Effectiveness Analyses Alongside Cancer Clinical Trials, 46 Discussion, 52 6 VALUE IN ONCOLOGY PRACTICE: ONCOLOGIST AND HEALTH INSURER PERSPECTIVES 55 Oncologists’ Perception of Value, 55 Paying for New Cancer Treatments: Rights and Responsibilities of Health Insurers, 57 International Perspectives on Assessing Value for Oncology Products, 61 Discussion, 65 7 ETHICAL ISSUES AND VALUE IN ONCOLOGY 69 Ethical Issues When Considering Insurance Coverage Based on Value in the Treatment of Cancer, 69 Clinician–Patient Communication About ­Cancer Therapy: Ethical Issues, 73 Discussion, 79 PART II: SOLUTIONS FOR VALUE IN CANCER CARE 8 IMPROVING VALUE IN ONCOLOGY PRACTICE: WAYS FORWARD 85 Value-Based Insurance Design: Initiatives Outside of Oncology, 85 Generating Evidence of Value Post-FDA Approval: Is There a Role for Health Insurers?, 88 Communicating Effectively with Cancer Patients About the Benefits and Risks of Cancer Treatments, 93 Concrete Ideas for Increasing Value in Oncology Care: A View from the Trenches, 96 Advocating for Value in Cancer Care, 103 Discussion, 104

CONTENTS xiii 9 TOWARD A SHARED UNDERSTANDING OF VALUE 109 Workshop Moderator Perspectives, 111 Group Discussion of Value in Cancer Care, 114 Attributes and Metrics of Value in Cancer Care, 115 ACRONYMS 117 GLOSSARY 119 APPENDIXES 125 A WORKSHOP AGENDA 125 B SPEAKER AND MODERATOR BIOGRAPHIES 129

Preface Oncology is similar to the other areas in health care in that it is under pressure to control expenditures while maintaining or improving quality of care and patient outcomes such that the value of oncology care is enhanced. Unlike many other areas in health care, the practice of oncology presents unique challenges that make assessing and improving value especially com- plex. First, patients and professionals feel a well-justified sense of urgency to treat for cure, and if cure is not possible, to extend life and reduce the burden of disease. Second, treatments are often both life sparing and highly toxic (and occasionally life threatening). Third, distinctive payment struc- tures for cancer medicines are intertwined with practice. Fourth, providers often face tremendous pressure to apply the newest technologies to patients who fail to respond to established treatments, even when the evidence sup- porting those technologies is incomplete or uncertain, and providers may be reluctant to stop toxic treatments and move to palliation, even at the end of life. Finally, the newest and most novel treatments in oncology are among the most costly in medicine. This report summarizes the results of a workshop that addressed these issues from multiple perspectives, including those of patients and patient advocates, providers, insurers, health care researchers, federal agencies, and industry. Its broad goal was to describe value in oncology in a complete and nuanced way, in order to identify areas of agreement such that a more uniform understanding of value would be available to those faced with decisions regarding developing, evaluating, prescribing, and paying for xv

xvi preface cancer therapeutics. As the national discussion around health care costs and value continues, a practical working description of value in oncology would benefit many stakeholders and serve as a useful model for other fields of medicine. The first part of the workshop focused on features of oncology that impact the value proposition. The second part presented potential approaches to improve value in cancer care. During the final session, par- ticipants discussed how the concept of value in cancer care is understood now and how it may be understood in the future, exploring any contrasting views and building on areas of agreement. It is hoped that readers of this will gain insight into the many facets of and challenges to assessing value in cancer care, and perhaps feel the enthu- siasm shared by the workshop participants regarding the need to better define value, such that cancer care can improve patients’ lives as efficiently and effectively as possible under the reality of the need to control spiraling health care costs. Scott Ramsey, MD, PhD Scott D. Ramsey, M.D., Ph.D. Chair, Planning Committee on Assessing and Improving Value in Cancer Care Member, National Cancer Policy Forum Member, Fred Hutchinson Cancer Research Center

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Unlike many other areas in health care, the practice of oncology presents unique challenges that make assessing and improving value especially complex. First, patients and professionals feel a well-justified sense of urgency to treat for cure, and if cure is not possible, to extend life and reduce the burden of disease. Second, treatments are often both life sparing and highly toxic. Third, distinctive payment structures for cancer medicines are intertwined with practice. Fourth, providers often face tremendous pressure to apply the newest technologies to patients who fail to respond to established treatments, even when the evidence supporting those technologies is incomplete or uncertain, and providers may be reluctant to stop toxic treatments and move to palliation, even at the end of life. Finally, the newest and most novel treatments in oncology are among the most costly in medicine.

This volume summarizes the results of a workshop that addressed these issues from multiple perspectives, including those of patients and patient advocates, providers, insurers, health care researchers, federal agencies, and industry. Its broad goal was to describe value in oncology in a complete and nuanced way, to better inform decisions regarding developing, evaluating, prescribing, and paying for cancer therapeutics.

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