SETTING PRIORITIES FOR HEALTH TECHNOLOGY ASSESSMENT

A MODEL PROCESS

Molla S. Donaldson and Harold C. Sox, Jr., Editors

Committee on Priorities for Assessment and Reassessment of Health Care Technologies

Institute of Medicine

NATIONAL ACADEMY PRESS
Washington, D.C. 1992



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Setting Priorities for Health Technology Assessment: A Model Process SETTING PRIORITIES FOR HEALTH TECHNOLOGY ASSESSMENT A MODEL PROCESS Molla S. Donaldson and Harold C. Sox, Jr., Editors Committee on Priorities for Assessment and Reassessment of Health Care Technologies Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. 1992

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Setting Priorities for Health Technology Assessment: A Model Process 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. The members of the committee responsible for this report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Support for this project was provided by the Agency for Health Care Policy and Research and the National Research Council. Library of Congress Catalog Card No. 92-80702 International Standard Book Number 0-309-04696-3 Additional copies of this report are available from: National Academy Press 2101 Constitution Avenue, NW Washington, DC 20418 S-556 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 image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.

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Setting Priorities for Health Technology Assessment: A Model Process COMMITTEE ON PRIORITIES FOR ASSESSMENT AND REASSESSMENT OF HEALTH CARE TECHNOLOGIES HAROLD C. SOX, JR. (Chair), Professor and Chair, Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire ROBERT A. BERENSON, Medical Director, National Capital Preferred Provider Organization and Practitioner in Internal Medicine, Washington, D.C. PETER BOUXSEIN, Deputy Executive Vice President, American College of Physicians, Philadelphia, Pennsylvania GLENNA M. CROOKS, Executive Director, Merck and Company, Rahway, New Jersey B. KRISTINE JOHNSON, Vice President and General Manager, Tachyarrhythmia Division, Medtronic, Inc., Minneapolis, Minnesota BRYAN R. LUCE, Director, Battelle Medical Technology Assessment and Policy (MEDTAP) Research Center, Washington, D.C. CHARLES E. PHELPS,* Professor and Chair, Department of Community and Preventive Medicine, and Professor, Political Science and Economics, University of Rochester, Rochester, New York RUTH B. PURTILO, Professor of Clinical Ethics, Center for Health Policy and Ethics, Creighton University, Omaha, Nebraska MICHAEL F. ROIZEN, Professor and Chair, Department of Anesthesia and Critical Care, and Professor, Department of Internal Medicine, University of Chicago, Chicago, Illinois CARY S. SENNETT, Medical Director and Director, Clinical Quality Management, AEtna Life and Casualty, Hartford, Connecticut GEORGE F. SHELDON, Professor and Chair, Department of Surgery, University of North Carolina at Chapel Hill CATHY SULZBERGER, Chevy Chase, Maryland GAlL L. WARDEN,* President and Chief Executive Officer, Henry Ford Health System, Detroit, Michigan STUDY STAFF Division of Health Care Services KARL D. YORDY, Director KATHLEEN N. LOHR, Deputy Director MOLLA S. DONALDSON, Study Director THERESA H. NALLY, Senior Secretary *    Member, Institute of Medicine

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Setting Priorities for Health Technology Assessment: A Model Process Acknowledgments As in any effort of this kind, thanks are due to many people who assisted the committee. Several made presentations at its meetings and reflected on its work. They included Richard Goldbloom of the Canadian Task Force on the Periodic Examination; Thomas Holohan, director of the Office of Technology Assessment at the Agency for Health Care Policy and Research (AHCPR); J. Sanford Schwartz at the Leonard Davis Institute of Health Economics, University of Pennsylvania; and Steven Thacker of the Centers for Disease Control. As the committee developed its model, it sought and received valuable additional advice, especially on the feasibility of the model, from Clyde Behney at the Office of Technology Assessment, David Eddy of Duke University, Steven Thacker of the Centers for Disease Control, Seymour Perry of the Program on Technology and Health Care at Georgetown University, Linda Johnson White of the Clinical Assessment and Efficacy Program of the American College of Physicians, and representatives of the American Managed Care Review Association, Blue Cross and Blue Shield Association, Group Health Association, the Health Industry Manufacturers Association, the Health Insurance Association of America, and Prudential Insurance Company of America. Kathleen Buto, director of the Bureau of Policy Development of the Health Care Financing Administration, and Michael Hash, senior staff associate for the Subcommittee on Health and the Environment, House Committee on Energy and Commerce, also provided helpful insight on the federal role in technology assessment. Several members of the Institute of Medicine staff critiqued the manuscript. Annetine Gelijns reviewed Chapter 2. Everette James, an IOM vis-

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Setting Priorities for Health Technology Assessment: A Model Process iting scholar, provided many helpful comments on medical technologies. Richard Rettig provided a wealth of background material and historical knowledge and critiqued Chapter 1. Michael Stoto critiqued an early draft of the quantitative model. Kathleen Lohr not only reviewed the manuscript but helped to solve many quandaries throughout the study—we are particularly appreciative of her efforts. We are also indebted to the staff efforts of Leah Mazade for her skillful editorial review, to Nina Spruill, financial analyst, and to John Devereux and Donna Thompson for their help in preparing the manuscript. Karl Yordy, director of the Division of Health Care Services, provided counsel during the study. Two other individuals deserve special mention. At Dartmouth-Hitchcock Medical Center, Ray Kulite of MHMH Productions produced a briefing videotape for the committee. Mary Kiernan, executive secretary to Dr. Sox, was unfailingly helpful and gracious. Finally, financial support for this study was provided by the U.S. Public Health Service, Department of Health and Human Services, and the National Research Council. The committee would like to acknowledge the valuable assistance of Steven Hotta, in AHCPR's Office of Health Technology Assessment, who acted as the study's project officer.

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Setting Priorities for Health Technology Assessment: A Model Process Contents     PREFACE   xiii     SUMMARY   1     Rationale,   1     Methods of Priority Setting,   2     Guiding Principles,   3     The Process Proposed by the IOM Committee,   4     Steps in the Process,   4     Seven Criteria,   5     Reassessment,   5     The Priority-Setting Cycle,   5     Human Resources Required to Implement the Process,   6     Publicly Available Products,   6     Topics for Which There Is Insufficient Evidence to Conduct an Assessment Based on Review of the Literature,   6     Recommendations,   6     Recommendation 1,   8     Recommendation 2,   8     Recommendation 3,   9     Recommendation 4,   9     Recommendation 5,   10     Recommendation 6,   11     Recommendation 7,   11     Recommendation 8,   12

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Setting Priorities for Health Technology Assessment: A Model Process     Recommendation 9,   12     Recommendation 10,   12     Recommendation 11,   13     Adoption of the IOM's Priority-Setting Process by Other Organizations,   13     Technology Assessment and Clinical Practice Guidelines,   14     Potential Problems with the Priority-Setting Process,   15     Concluding Remarks,   15 1   TECHNOLOGY ASSESSMENT AND THE NEED FOR PRIORITY SETTING   17     Evolution of Technology Assessment Toward Outcomes, Effectiveness, and Appropriateness Research,   18     The Effectiveness Initiative and Establishment of the Agency for Health Care Policy and Research,   20     The Office of Health Technology Assessment,   20     Origin of the IOM Study,   21     Previous Pilot Study of Preliminary Model,   21     Study Methods,   22     Definitions,   23     Medical Technology,   23     Technology Assessment,   23     Reassessment,   25     Report Structure,   26     Summary,   26     Appendix: The Agency for Health Care Policy and Research,   26     Center for Medical Effectiveness Research,   27     Office of the Forum for Quality and Effectiveness in Health Care,   27     Office of Science and Data Development,   27     Center for General Health Services Extramural Research and the Division of Technology and Quality Assessment,   28     Office of Health Technology Assessment,   28 2   METHODS FOR PRIORITY SETTING   31     Priority-Setting Processes Used by Organizations,   32     Example 1: Health Care Financing Administration,   32     Example 2: Private Sector Pharmaceutical Industry,   33     Example 3: Health Care Provider Organizations,   35     Example 4: Institute of Medicine/Council on Health Care Technology Pilot Study,   36     Example 5: Food and Drug Administration,   37     Quantitative Models for Setting Priorities,   38

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Setting Priorities for Health Technology Assessment: A Model Process     Example 6: Technology Assessment Priority-Setting System,   38     Example 7: The Phelps-Parente Model,   38     Setting Priorities for Spending on Health Services,   39     Example 8: Oregon Basic Health Services Act,   39     Discussion,   41     Reactive and Implicit Processes,   41     Analytic Models,   43     Need for a Comprehensive, Proactive Process for Priority Setting,   44     Summary,   44     Appendix: Medicare Coverage Decision Making,   45 3   GUIDING PRINCIPLES   50     Building a Model Process for Setting Priorities,   50     Process Building for OHTA,   51     The Process Must Reflect the Mission of OHTA,   51     The Product of the Process Should Be Consistent with the Needs of Users,   53     The Process Must Be Efficient,   54     The Process Must Be Sensitive to the Environment in Which OHTA Operates,   55     Summary,   56 4   RECOMMENDATIONS FOR A PRIORITY-SETTING PROCESS   57     Preview of the Quantitative Model,   59     Elements of the Proposed Priority-Setting Process,   60     Step 1. Selecting and Weighting Criteria Used to Establish Priorities,   60     Step 2. Identifying Candidate Conditions and Technologies,   61     Step 3. Winnowing the List of Candidate Conditions and Technologies,   62     Step 4. Data Gathering,   62     Step 5. Creating Criterion Scores,   62     Step 6. Computing Priority Scores,   63     Step 7. Review by AHCPR National Advisory Council,   64     Details of the Proposed Priority-Setting Process,   64     Step 1. Selecting and Weighting the Criteria Used to Establish Priority Scores,   64     Step 2. Identifying Candidate Conditions and Technologies,   66     Step 3. Winnowing the List of Candidate Conditions and Technologies,   66     Step 4. Data Gathering,   68

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Setting Priorities for Health Technology Assessment: A Model Process     Step 5. Creating Criterion Scores,   69     Step 6. Computing Priority Scores,   83     Step 7. Review by AHCPR National Advisory Council,   87     Reassessment,   88     Role of Reassessment in the Complete Assessment Program,   88     Methods of Identifying Candidates for Reassessment,   90     Final Steps After Establishing Priority for Reassessment,   94     Summary,   94     Appendix 4.1: Winnowing Processes,   95     Intensity Rankings by Nominating Persons and Organizations,   95     Preliminary Ranking Processes,   97     Panel-Based Preliminary Weighting,   98     Comment,   99     Appendix 4.2: Methodologic Issues,   100     Properties of Logarithms,   101     Application to the IOM Model,   102 5   IMPLEMENTATION ISSUES   103     The Priority-Setting Cycle,   103     Setting Criterion Weights,   104     Resources Needed to Implement the Process,   105     Technology Assessment Program Staff Requirements,   105     Priority-Setting Panel,   106     Implementation Considerations for OHTA and Other Organizations,   108     Validity and Reliability,   108     Criteria,   109     Availability of Data to Generate Criterion Scores,   110     Publicly Available Products,   110     When the Scientific Evidence Is Insufficient for Assessment,   111     Interim Statements,   112     Modeling,   112     Summary,   113 6   RECOMMENDATIONS AND CONCLUSIONS   115     Review of the Committee's Rationale and Recommendations,   115     Recommendations,   116     Review of Steps and Issues in Implementation,   122     Steps in a Priority-Setting Process,   122     Resources for Implementation,   123     The Priority-Setting Cycle,   124     Publicly Available Products,   124

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Setting Priorities for Health Technology Assessment: A Model Process     Topics with Insufficient Evidence for Assessment Based on Review of the Literature,   124     Adoption of the IOM'S Priority-Setting Process by Other Organizations,   125     Technology Assessment and Clinical Practice Guidelines,   127     Potential Problems with the Priority-Setting Process,   127     Will a Numerical Priority Score Lead to Unrealistic Inferences About Priority?   128     Does Codifying an Idealized Process Lead to Inflexibility?   128     Will There Be a Bias Toward Choosing Topics That Are Quantifiable?   128     Conclusion,   129     REFERENCES   131 APPENDIX A:   PILOT TEST OF THE IOM MODEL   136     Methods,   137     Topics and Data for Priority Setting,   137     Criteria,   137     Criterion Weighting,   138     Criterion Scoring,   138     Results,   139     Feasibility,   139     Improvements in the Model,   139     Comparison of Convened and Mailed Methods,   139     Priority Scores,   141     Implications of the Pilot Tests for the IOM Model,   143     Criterion Scores,   144 APPENDIX B:   ABBREVIATIONS   146

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Setting Priorities for Health Technology Assessment: A Model Process Preface The immediate objective of this report is to provide a government agency with a method for deciding which health care technologies it should evaluate. The origin of the task is the 1989 legislation that authorized the creation of the Agency for Health Care Policy and Research. The legislation called upon the new agency to promote health care technology assessment by, among other means, deciding which technologies are the most important to evaluate. The agency asked the Institute of Medicine to study methods for setting priorities and to advise its Office of Health Technology Assessment. The problem of deciding which health technologies to evaluate is a new problem, and it is urgent. Health technology assessment itself is a new field. It came to fruition during the 1980s, when new health technologies proliferated alongside steadily increasing health care costs. Many experts blamed physicians for indiscriminately using these technologies. The real problem was our failure to do the research that can teach us how to be discriminating. Directing tests and treatments at those who can benefit the most is the unmet challenge. Technology assessment can help to solve this problem by discovering the answer to the question, ''What works in the practice of medicine?'' The answer can often be found by applying rigorous epidemiologic thinking to the published literature. The problem is that there are many clinical problems and technologies to be evaluated, many months of work required to study one problem, and relatively few clinicians with highly developed analytic skills. Therefore, institutions must set priorities.

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Setting Priorities for Health Technology Assessment: A Model Process When the Agency for Health Care Policy and Research asked for advice, the Institute of Medicine convened a study group. Our committee's first task was to learn how organizations set priorities. We found that there is little published literature on priority setting in the health field. Unfettered by tradition, we sought a method that would satisfy several criteria that we felt should be important to any public agency. First, the method should provide opportunities for the public to express its values. Second, the method should be explicit, so that people can trace backwards from results to inputs and so satisfy themselves that the process was fair. Third, priority for assessment should reflect the potential benefit to the public from doing an assessment. Will this report have a broad readership? We certainly hope so. The Institute of Medicine gave us a broad mandate: satisfy the needs of the agency but keep in mind the needs of other organizations that do technology assessment. We therefore tried to develop a generally applicable method for setting priorities. We hope that other organizations will find this priority-setting method to be useful. Some organizations may find the entire method to their liking; others will find some elements of it attractive and will reject others. As authors, we will be quite pleased if we can engage the reader's interest in a problem that we found challenging and important. Harold C. Sox, Jr., M.D. Chair, Committee on Priorities for Assessment and Reassessment of Health Care Technologies

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Setting Priorities for Health Technology Assessment: A Model Process SETTING PRIORITIES FOR HEALTH TECHNOLOGY ASSESSMENT A MODEL PROCESS

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