The Changing Economics of Medical Technology -- Copyright -- Acknowledgments -- Preface -- Contents -- List of Abbreviations -- 1 An Introduction to the Changing Economics of Technological Innovation in Medicine -- A DYNAMIC MODEL OF TECHNOLOGICAL INNOVATION IN MEDICINE -- THE DYNAMICS OF PHARMACEUTICAL INNOVATION -- THE DYNAMICS OF DEVICE INNOVATION -- THE DYNAMICS OF SURGICAL INNOVATION -- INTERNATIONAL COMPARISONS: EUROPE AND JAPAN -- CONCLUDING OBSERVATIONS -- NOTES -- REFERENCES -- 2 The Diffusion of New Technology: Costs and Benefits to Health Care -- HOW MUCH DOES NEW TECHNOLOGY ADD TO HEALTH CARE COSTS? -- OPTIMAL DIFFUSION OF TECHNOLOGY: THE COST-EFFECTIVENESS PRINCIPLE -- EFFECTS OF REIMBURSEMENT ON THE USE OF NEW TECHNOLOGIES -- Hospitals -- HMOs and Managed Care Plans -- Incentives for Fee-for-Service Physicians -- FUTURE DIRECTIONS: HOW TO ACHIEVE COST-EFFECTIVE DIFFUSION OF MEDICAL TECHNOLOGY -- NOTE -- REFERENCES -- 3 The Changing Economics of Pharmaceutical Research and Development -- CURRENT TRENDS -- R&D Opportunities -- R&D Costs -- Product Life Cycles -- Effective Patent Life -- Drug Prices -- RETURN TO PHARMACEUTICAL R&D -- IMPLICATIONS -- PUBLIC POLICY CONSIDERATIONS -- NOTES -- REFERENCES -- 4 Public Policy and Access to New Drugs: The Case of Cancer Chemotherapy -- CANCER CARE: A SERIES OF INCREMENTAL INNOVATIONS -- A PERIOD OF TRANSITION: FROM RAPID GROWTH TO STRICT CONTROL -- REIMBURSEMENT POLICIES AND THEIR EFFECT ON THE USE OF NEW TECHNOLOGIES -- The Effects of the Prospective Payment System -- The Dis-Integration of Care -- Growing Patterns of Denial of Payment -- Off-Label Use and New Indications -- Payment for Investigational Therapies -- EFFECTS OF REIMBURSEMENT POLICIES ON INNOVATION -- The Impact of the PPS on Clinical Research -- Decreasing Effective Patent Life.

GROWING DISINCENTIVES TO PROVIDING STATE-OF-THE-ART CARE -- PROSPECTS FOR THE FUTURE -- NOTE -- REFERENCES -- 5 The Impact of Public Policy on Medical Device Innovation: A Case of Polyintervention -- THE ASSESSMENT: PUBLIC POLICIES AND MEDICAL DEVICE INNOVATION -- The Limits of the Traditional Models of Innovation -- The Pivotal Role of Public Policy -- THE MEDICAL DEVICE INDUSTRY AS PATIENT -- THE EVALUATION: THE IMPACT OF POLYINTERVENTION -- Case Study: Lithotripsy -- Case Study: Intraocular Lenses -- TREATMENT OPTIONS: IMPROVING THE PUBLIC POLICY ENVIRONMENT -- Fine-tuning Individual Policies -- Understanding Polyintervention -- CONCLUSION -- NOTE -- REFERENCES -- 6 The Dynamics of Medical Device Innovation: An Innovator's Perspective -- PATENTS -- WHO DOES R&D? -- FINANCING OF INNOVATION -- REGULATORY DIFFERENCES -- THE ROLE OF LIABILITY -- REIMBURSEMENT -- CONCLUSIONS -- SELECTIVE BIBLIOGRAPHY -- 7 Reimbursement and the Dynamics of Surgical Procedure Innovation -- DEVELOPMENT OF NEW SURGICAL PROCEDURES -- Types of New Surgical Procedures -- The Development Process for Surgical Procedures -- Comparison of the Development of Drugs, Devices, and Procedures -- Incentives in the Innovation Process -- PAYMENT FOR SURGICAL PROCEDURES -- Determining Coverage for New Procedures -- Issues of Coding -- Physicians -- Hospitals -- Payment Problems with New Procedure Classifications -- Interaction of Diffusion and Competition -- Selective Contracting for Surgical Procedures -- Limitations of Selective Contracting -- Outpatient Procedures and Payment Incentives -- OBSERVATIONS, IMPRESSIONS, AND SPECULATIONS -- NOTES -- REFERENCES -- 8 European Policies Influencing Pharmaceutical Innovation -- THE PROCESS OF INNOVATION -- Discovery -- Development and Regulation -- RECOVERING THE INVESTMENT -- Patent Protection -- Prices -- Generics -- SUBSIDIES FOR R&D.

THOUGHTS -- Is the United States a Better Place for Pharmaceutical Innovation? -- Are There Lessons for the United States from the European Experience? -- 1992 and after -- NOTES -- REFERENCES -- 9 Medical Device Innovation and Public Policy in the European Economic Community -- PUBLIC POLICY AND INNOVATION: A MODEL -- Social Objectives -- Parties of Interest -- Policy Responses -- THE EUROPEAN HEALTH CARE ENVIRONMENT -- Public Health Care Systems -- Social Security Health Care Systems -- Private Health Care Systems -- THE EUROPEAN MEDICAL DEVICE MARKET -- FACTORS INFLUENCING MEDICAL DEVICE INNOVATION -- Research and Development -- Regulation -- Reimbursement -- THE ROLE OF THE EUROPEAN COMMUNITY -- CONCLUSIONS -- NOTES -- REFERENCES -- 10 Japan's Pharmaceutical Industry Postwar Evolution -- PHASE I: EMERGENCE (MID 1940S TO MID 1960S) -- PHASE II: TRANSFORMATION (MID 1960S TO LATE 1970S) -- PHASE III: RETRANSFORMATION (THE 1980S) -- PHASE IV: THE 1990S AND BEYOND -- A FINAL WORD -- SELECTIVE BIBLIOGRAPHY -- English Language -- Japanese Language -- Appendix A The Impact of Regulation and Reimbursement on Pharmaceutical Innovation -- REGULATION AND PHARMACEUTICAL INNOVATION -- Preclinical Testing -- Clinical Investigation: The IND Phase -- FDA Approval: The NDA Phase -- Post-Marketing Requirements -- Generic Drug Competition -- The Overall Impact of Regulation on Innovation -- REIMBURSEMENT AND PHARMACEUTICAL INNOVATION -- The Big Players: Public and Private Payers -- Inconsistencies in Payment Policies -- Investigational Therapies -- Compassionate Use -- New Indications and Off-Label Use -- Assessing the Overall Impact of Payment Policies -- NOTES -- SELECTIVE BIBLIOGRAPHY -- Appendix B The Economics of Pharmaceutical Research and Development: An Industry Perspective -- THE COMPETITIVE, COSTLY SEARCH FOR NEW DRUGS -- MEGAMERGERS.

IMPACT ON TAX RECEIPTS AND BALANCE OF TRADE -- ACADEMIC ANALYSES: ECONOMIC AND FINANCIAL -- SHORTER PRODUCT LIFE CYCLES -- ADVANCED MARKETING STRATEGIES -- RISK-ADJUSTED ECONOMIC RETURNS -- PROTECTING INTELLECTUAL PROPERTY -- THE REGULATORY ENVIRONMENT -- DRUG PRICES -- GOVERNMENT SUPPORT OF BASIC RESEARCH -- INDUSTRY'S ROLE IN APPLIED RESEARCH -- U.S. SCIENCE EDUCATION -- THE WORLDWIDE ENVIRONMENT -- A FINAL CHALLENGE -- THE FUTURE -- NOTES -- REFERENCES -- Appendix C Contributors -- Index.