Making Medicines Affordable

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

A Real Plan for Making Drugs Affordable–and Promoting Innovation, Too “This book is a necessity for understanding the pharmaceutical industry. Both the pluses and minuses of the present system are set forth with a judicious combination of historical narrative, economic analysis, and statistical data. The highly original proposals for reform will be a major stimulant to analysis and policy-making.” –Kenneth Arrow, Nobel Laureate in Economics, Professor Emeritus, Stanford University “This is a timely book by authors who know what they are talking about. They tackle a big problem: rising drug prices that are threatening to overwhelm us all–and especially those with limited or absent health care insurance. Will we drive people overseas for healthcare? Will there be social unrest? This book describes the problem and then offers a solution. Worth a careful read by everyone, pharmaceutical manufacturers and government policymakers especially.” –Roger Williams, M.D., Chief Executive Officer of the United States Pharmacopeia and a former senior official of the Food and Drug Administration “This book confounds two sets of skeptics: Those who say there’s no way to resolve the conflict between the need to fund pharmaceutical research and our desire to keep medicine affordable; and those who think that economics never has anything good to say.” –Honorable Barney Frank, Congressman from Massachusetts “This book comes at the right time and could become the starting point of discussions, which will eventually lead us into new era in the healthcare care industry. It will without a doubt become a must for insiders of the pharma- and biotech industries.” –Dr. Jürgen Drews, retired President of Roche Pharmaceutical Group Global Research Acknowledgments viii About the Authors ix Introduction xi Chapter 1: Drugs and Drug Prices 1 Chapter 2: The American Way to Discover Drugs 21 Chapter 3: The Drug Industry Today 39 Chapter 4: Are Drug Companies Risky? 59 Chapter 5: How Not to Lower Drug Prices 77 Chapter 6: Squandering R & D Resources 103 Chapter 7: How to Lower Drug Prices 129 Appendix: Our Solution in Detail 155 Index 177

Cover -- Contents -- Acknowledgments -- Introduction -- Part I. Toxic Impacts -- 1. People Everywhere Are Struggling to Get the Medicines They Need -- 2. The United States Has a Drug Problem -- 3. Millions of People Are Dying Needlessly -- 4. Cancer Patients Face Particularly Deadly Barriers to Medicines -- 5. The Current Medicine System Neglects Many Major Diseases -- Part II. Profits over Patients -- 6. Corporate Research and Development Investments Are Exaggerated -- 7. The Current System Wastes Billions on Drug Marketing -- 8. The Current System Compromises Physician Integrity and Leads to Unethical Corporate Behavior -- 9. Medicines Are Priced at Whatever the Market Will Bear -- 10. Pharmaceutical Corporations Reap History-Making Profits -- Part III. Patently Poisonous -- 11. The For-Profit Medicine Arguments Are Patently False -- 12. Medicine Patents Are Extended Too Far and Too Wide -- 13. Patent Protectionism Stunts the Development of New Medicines -- 14. Governments, Not Private Corporations, Drive Medicine Innovation -- 15. Taxpayers and Patients Pay Twice for Patented Medicines -- Part IV. Trading Away Our Health -- 16. Medicines Are a Public Good -- 17. Medicine Patents Are Artificial, Recent, and Government-Created -- 18. The United States and Big Pharma Play the Bully in Extending Patents -- 19. Pharma-Pushed Trade Agreements Steal the Power of Democratically Elected Governments -- Part V.A Better Remedy -- 20. Current Law Provides Opportunities for Affordable Generic Medicines -- 21. There Is a Better Way to Develop Medicines -- 22. Human Rights Law Demands Access to Essential Medicines -- Conclusion -- Notes -- Index

"At a time when governments are trying to reduce escalating expenditures on medicines in their health care systems or are trying to increase access to quality medicines for their people, this book provides some experiences gained in this field"--Page 4 of cover.

In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.

Do we really have to choose between affordability of drugs and lifesaving innovation? No. In The Great American Drug Deal, Peter Kolchinsky offers clear-eyed analysis, compelling stories, and vital ideas for closing loopholes, dealing with bad actors, supporting patients, and fueling discoveries that ease suffering now and for generations to come.

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.