National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
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—— Ensuring ——

PATIENT ACCESS

to Affordable

CANCER DRUGS

————

Workshop Summary

Sharyl J. Nass and Margie Patlak, Rapporteurs

National Cancer Policy Forum

Board on Health Care Services

INSTITUTE OF MEDICINE
             OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
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THE NATIONAL ACADEMIES PRESS     500 Fifth Street, NW     Washington, DC 20001

NOTICE: The workshop that is the subject of this workshop summary 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 project was supported by Contract No. HHSN261200900003C between the National Academy of Sciences and the Centers for Disease Control and Prevention and by the American Association for Cancer Research, the American Cancer Society, the American Society for Radiation Oncology, the American Society of Clinical Oncology, the American Society of Hematology, the Association of American Cancer Institutes, C-Change, the CEO Roundtable on Cancer, EMD Serono, Helsinn Healthcare SA, the LIVESTRONG Foundation, the National Comprehensive Cancer Network, Novartis Oncology, the Oncology Nursing Society, and Sanofi Oncology. Additional funding for this workshop was provided by ION Solutions. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity.

International Standard Book Number-13: 978-0-309-31270-7
International Standard Book Number-10: 0-309-31270-1

Additional copies of this workshop summary are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

For more information about the Institute of Medicine (IOM), visit the IOM home page at: www.iom.edu.

Copyright 2014 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). 2014. Ensuring patient access to affordable cancer drugs: Workshop summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.
”      

                                                —Goethe

image

INSTITUTE OF MEDICINE
                 OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

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 mandate 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. C. D. Mote, Jr., 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. Victor J. Dzau 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. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
×

WORKSHOP PLANNING COMMITTEE1

PETER B. BACH (Chair), Attending Physician, Center for Health Policy and Outcomes, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center

BARRY FORTNER, President, ION Solutions

PATRICIA A. GANZ, Distinguished Professor, Health Policy & Management and Medicine, UCLA Fielding School of Public Health, David Geffen School of Medicine at UCLA; Director, Cancer Prevention & Control Research, Jonsson Comprehensive Cancer Center

CAROL A. HAHN, Associate Professor of Radiation Oncology, Duke University Medical Center, and Medical Director of Radiation Oncology, Duke Raleigh Hospital, Department of Radiation Oncology

MARTIN J. MURPHY, Chief Executive Officer, CEO Roundtable on Cancer

LEE NEWCOMER, Senior Vice President, Oncology, Genetics and Women’s Health, UnitedHealth Group

RITA NORTON, Senior Vice President, Government Affairs, AmerisourceBergen

SCOTT RAMSEY, Full Member, Fred Hutchinson Cancer Research Center, and Director, Hutchinson Institute for Cancer Outcomes Research

RICHARD SCHILSKY, Chief Medical Officer, American Society of Clinical Oncology

DEBORAH SCHRAG, Chief, Division of Population Sciences, Professor of Medicine, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School

YA-CHEN TINA SHIH, Associate Professor, Section of Hospital Medicine, Department of Medicine Director, Program in the Economics of Cancer, University of Chicago

JEFFERY WARD, Medical Oncologist, Swedish Cancer Institute, Seattle, WA

_____________

1Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
×

Project Staff

SHARYL J. NASS, Director, National Cancer Policy Forum

SARA THARAKAN, Research Assistant

HANNAH DURING, Senior Program Assistant

CELYNNE BALATBAT, Senior Program Assistant

Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
×

NATIONAL CANCER POLICY FORUM1

MICHAEL CALIGIURI (Chair), CEO, James Cancer Hospital and Solove Research Institute, and Director, OSU Comprehensive Cancer Center, The Ohio State University

PATRICIA A. GANZ (Vice Chair), Distinguished Professor, Health Policy & Management and Medicine, UCLA Fielding School of Public Health, David Geffen School of Medicine at UCLA; Director, Cancer Prevention & Control Research, Jonsson Comprehensive Cancer Center

AMY P. ABERNETHY, Associate Professor of Medicine, Duke University School of Medicine, and Director, Duke Cancer Care Research Program, Durham, NC

LUCILE ADAMS-CAMPBELL, Professor of Oncology, Associate Director for Minority Health and Health Disparities Research, Georgetown University Lombardi Cancer Center

KENNETH ANDERSON, Kraft Family Professor of Medicine, American Cancer Society Clinical Research Director, Jerome Lipper Multiple Myeloma Center, Harvard Medical School, Dana-Farber Cancer Institute

LOYCE PACE BASS, Health Policy Director, LIVESTRONG Foundation

MONICA BERTAGNOLLI, Professor of Surgery, Harvard Medical School, Boston, MA

OTIS BRAWLEY, Chief Medical Officer and Executive Vice President, American Cancer Society, Atlanta, GA

CARLTON BROWN, Director of Professional Services, Oregon Nurses Association, and past president, Oncology Nursing Society

SERGIO CANTOREGGI, Chief Scientific Officer and Global Head of Research and Development, Helsinn Group

ROBERT W. CARLSON, Chief Executive Officer, National Comprehensive Cancer Network

WILLIAM S. DALTON, CEO, M2Gen Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL, and Chair, American Association for Cancer Research Science Policy & Legislative Affairs Committee

_____________

1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
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GWEN DARIEN, Executive Vice President, Programs and Services, Cancer Policy Institute, Cancer Support Community

WENDY DEMARK-WAHNEFRIED, Associate Director for Cancer Prevention and Control, University of Alabama at Birmingham Comprehensive Cancer Center

CAROL A. HAHN, Associate Professor of Radiation Oncology, Duke University Medical Center, Durham, NC, and Medical Director of Radiation Oncology, Duke Raleigh Hospital, Raleigh, NC, and Clinical Affairs and Quality Council Chair, American Society for Radiation Oncology

LORI HOFFMAN HOGG, Cancer Program Director, Albany Stratton VA Medical Center

THOMAS J. KEAN, President and CEO, C-Change, Washington, DC

SAMIR N. KHLEIF, Director, Georgia Health Sciences University Cancer Center, Georgia Regents University Cancer Center

MICHELLE M. LE BEAU, Arthur and Marian Edelstein Professor of Medicine, Director, Comprehensive Cancer Center, University of Chicago, IL, and President, Association of American Cancer Institutes

SHARI LING, Deputy Chief Medical Officer, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services

DOUGLAS R. LOWY, Deputy Director, National Cancer Institute, Bethesda, MD

GRETA MASSETTI, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention

DANIEL R. MASYS, Affiliate Professor, Biomedical Informatics, University of Washington, Seattle

MARTIN J. MURPHY, Chief Executive Officer, CEO Roundtable on Cancer, Durham, NC

RICHARD PAZDUR, Director, Office of Oncology and Hematology Products, Food and Drug Administration

STEVEN PIANTADOSI, Phase One Foundation Endowed Chair and Director, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA

JENNIFER A. PIETENPOL, Director, Vanderbilt-Ingraham Cancer Center, Benjamin F. Byrd, Jr., Professor of Oncology, Professor of Biochemistry, Vanderbilt University

ANDREW SCHIERMEIER, Senior Vice President, Head of Global Oncology, Merck Serono

Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
×

RICHARD SCHILSKY, Chief Medical Officer, American Society of Clinical Oncology

DEBORAH SCHRAG, Chief, Division of Population Sciences, Professor of Medicine, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School

ADRIAN SENDEROWICZ, Vice President, Global Regulatory Affairs, Sanofi Oncology

YA-CHEN TINA SHIH, Director, Program in the Economics of Cancer, University of Chicago, IL

ELLEN V. SIGAL, Chair and Founder, Friends of Cancer Research, Washington, DC

STEVEN STEIN, Senior Vice President, U.S. Clinical Development and Medical Affairs, Novartis Oncology, East Hanover, NJ

RALPH WEICHSELBAUM, Daniel K. Ludwig Professor and Chair, Department of Radiation Oncology, and Director, Ludwig Center for Metastasis Research, University of Chicago Medical Center, IL

National Cancer Policy Forum Staff

SHARYL J. NASS, Forum Director and Interim Director, Board on Health Care Services (from June 2014)

SARA THARAKAN, Research Assistant

HANNAH DURING, Senior Program Assistant

PATRICK ROSS, Senior Program Assistant (from September 2014)

CELYNNE BALATBAT, Senior Program Assistant

PATRICK BURKE, Financial Associate

ROGER HERDMAN, Director, Board on Health Care Services (until June 6, 2014)

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Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
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Reviewers

This workshop summary 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 workshop summary as sound as possible and to ensure that the workshop summary 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 workshop summary:

MEGHAN BUZBY, International Myeloma Foundation

THOMAS FEELEY, The University of Texas MD Anderson Cancer Center

CAROL S. PALACKDHARRY, Healthcare Consultant and Medical Oncologist

LOWELL E. SCHNIPPER, Harvard Medical School and Beth Israel Deaconess Medical Center

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the work-

Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
×

shop summary before its release. The review of this report was overseen by JOSEPH P. NEWHOUSE, Harvard University. Appointed by the Institute of Medicine, he was responsible 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 rapporteurs and the institution.

Page xiii Cite
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Acknowledgments

Support from the many annual sponsors of the Institute of Medicine’s National Cancer Policy Forum is crucial to the work of the Forum. Current sponsors include the Centers for Disease Control and Prevention, the National Cancer Institute, the American Association for Cancer Research, the American Cancer Society, the American Society for Radiation Oncology, the American Society of Clinical Oncology, the American Society of Hematology, the Association of American Cancer Institutes, the Cancer Support Community, C-Change, the CEO Roundtable on Cancer, EMD Serono, Helsinn Healthcare SA, the LIVESTRONG Foundation, the National Comprehensive Cancer Network, Novartis Oncology, the Oncology Nursing Society, and Sanofi Oncology. Additional funding for this workshop was provided by ION Solutions.

The Forum wishes to express its gratitude to the expert speakers whose presentations helped define the current challenges and opportunities for ensuring patient access to affordable cancer drugs. The Forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda.

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Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
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Acronyms

ACA Patient Protection and Affordable Care Act
ANDA Abbreviated New Drug Application
ASCO American Society of Clinical Oncology
ASP average sales price
CDC Centers for Disease Control and Prevention
CMS Centers for Medicare & Medicaid Services
DSH disproportionate share hospital
EMR electronic medical record
FDA Food and Drug Administration
HRSA Health Resources and Services Administration
ICER incremental cost effectiveness ratio
IOM Institute of Medicine
IT information technology
MDACC The University of Texas MD Anderson Cancer Center
MedPAC Medicare Payment Advisory Committee
Suggested Citation:"Front Matter." Institute of Medicine. 2014. Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18956.
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NCPF National Cancer Policy Forum
NHS National Health Service
NICE National Institute for Health Care Excellence
PCORI Patient-Centered Outcomes Research Institute
QALY quality-adjusted life year
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In recent years, patients' out-of-pocket costs for cancer care have been rising rapidly. These costs include health insurance deductibles, coinsurance, and copayments for covered services, as well as services that are not covered by insurance. Many cancer patients are especially vulnerable financially because their illness and/or treatment impedes their ability to work, with some patients losing employment altogether. Even with insurance, cancer patients often experience financial hardships, such as going into debt, depleting all assets to pay for cancer treatment, and personal bankruptcy. Although many elements contribute to the cost of cancer care, one important component is the cost of new cancer drugs, which has been escalating rapidly in recent years. To explore the issue of cancer drug costs and patient access to affordable, appropriate drug therapies, the Institute of Medicine's National Cancer Policy Forum convened a workshop on ensuring patient access to affordable cancer drugs in June 2014. Affordability was considered from both individual and societal perspectives. The workshop featured discussion panels as well as invited presentations from clinicians, researchers, representatives from the health insurance and pharmaceutical industries, and patient advocates. Ensuring Patient Access to Affordable Cancer Drugs summarizes the presentation and discussion of the workshop.

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