Cover
Title Page
Copyright
Preface
Contents
Figures
Summary
Acknowledgments
Abbreviations
Chapter One: Introduction
Project Goals
What Determines Value for Health Care Products?
Three Stages of Innovation
Drug and Device Companies
Private Investors
Financial Incentives of Medical Product Inventors
Influencers of Medical Product Invention
U.S. Food and Drug Administration
Primary Actor and Influencers in Approval of Medical Technologies
Physicians
Hospitals
Influencers of Providers
Summary: Context for Medical Product Innovation
Literature Reviews
Technical Expert Panel
Expert Interviews
Case Studies
Policy Options
Chapter Four: Analysis
Lack of an Adequate Knowledge Base Can Hinder Product Inventors
Federal Funding Is Critical to Expanding the Basic Scientific Base
Case Study Summary: Haemophilus influenzae Type b (Hib) Vaccine
Could the FDA Ensure Safety with Quicker and Less Costly Processes?
Case Study Summary: A Cardiovascular Polypill
Unpredictability and Ineffective Communication Complicate the Approval Process
FDA Caution May Be a Root Cause of Regulatory Delay
Case Study Summary: Avastin for Metastatic Breast Cancer
How Regulatory Uncertainty Affects Investment and Invention
Limited Rewards for Medical Products That Could Lower Spending
Generous Health Insurance Tends to Reduce Consumers’ Sensitivity to Price
Medicare Is Not Allowed to Consider Costs in Coverage and Reimbursement Decisions
Limited Time Horizons and Fragmented Decisionmaking
Case Study Summary: Electronic Health Records
Implications for Inventors and Investors
Case Study Summary: Implantable Cardioverter-Defibrillator
Manufacturers Can Promote Low-Value Use
Case Study Summary: Prostate-Specific Antigen
It Is Difficult to Control Undesirable Instances of Off-Label Use
The Classical Medical Arms Race
Expensive and Controversial Medical Equipment Remains Prominent
Case Study Summary: Robotic Surgery
The Medical Arms Race Can Substantially Affect Incentives of Inventors
Chapter Five: Policy Options to Improve the U.S. Medical Product Innovation System
Enable More Creativity in Funding Basic Science
Offer Prizes for Inventions
Buy Out Selected Patents
Expedite FDA Reviews and Approvals for Products That Decrease Spending
Options to Increase Market Rewards
Reform Medicare Payment Policies
Reform Medicare Coverage Policies
Coordinate FDA Approval and CMS Coverage Processes
Increase Demand for Products That Could Decrease Spending
Case Study Summary: Telemedicine
Summary
Chapter Six: In Conclusion
A. Cost-Effectiveness and Value
B. An Economic Model of Innovation
References
