The Oxford Handbook Of The Economics Of The Biopharmaceutical Industry

The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms as generics replace their former blockbuster products. This timely volume examines the economics of the biopharmaceutical industry, with eighteen chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the Food and Drug Administration (FDA) and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialized countries, and in developing countries. It looks at the optimal design of insurance for drugs and the effects of cost sharing on spending and on health outcomes; how to measure the value of pharmaceuticals using pharmacoeconomics, including theory, practical challenges, and policy issues; how to measure pharmaceutical price growth over time and recent evidence; empirical evidence on the value of pharmaceuticals in terms of health outcomes; promotion of pharmaceuticals to physicians and consumers; the economics of vaccines; and a review of the evidence on effects of mergers, acquisitions and alliances. Each chapter summarizes the latest insights from theory and recent empirical evidence, and outlines important unanswered questions and areas for future research. Based on solid economics, it is nevertheless written in terms accessible to the general reader. The book is thus recommended reading for academic economists and non-economists, and for those in industry and policy who wish to understand the economics of this fascinating industry.

The Oxford Handbook of Health Economics provides an accessible and authoritative guide to health economics, intended for scholars and students in the field, as well as those in adjacent disciplines including health policy and clinical medicine. The chapters stress the direct impact of health economics reasoning on policy and practice, offering readers an introduction to the potential reach of the discipline. Contributions come from internationally-recognized leaders in health economics and reflect the worldwide reach of the discipline. Authoritative, but non-technical, the chapters place great emphasis on the connections between theory and policy-making, and develop the contributions of health economics to problems arising in a variety of institutional contexts, from primary care to the operations of health insurers. The volume addresses policy concerns relevant to health systems in both developed and developing countries. It takes a broad perspective, with relevance to systems with single or multi-payer health insurance arrangements, and to those relying predominantly on user charges; contributions are also included that focus both on medical care and on non-medical factors that affect health. Each chapter provides a succinct summary of the current state of economic thinking in a given area, as well as the author's unique perspective on issues that remain open to debate. The volume presents a view of health economics as a vibrant and continually advancing field, highlighting ongoing challenges and pointing to new directions for further progress.

From a managerial perspective, the biopharmaceutical industry represents a competitive, fast-changing, intellectually-powered, innovation-driven sector. Many management scholars have studied this discontinuous era to make sense of strategic behavior and the cognition of firms and top managers. A past look at the biopharmaceutical industry provides answers to questions that most managers have. For example, what options do you have and what actions do you take when new firms enter your industry? In the 1970s, new biotechnology firms, funded by venture capitalists, appeared in the pharmaceutical industry with new knowledge. Successful pharmaceutical firms decided to collaborate with the new entrants and forge relationships to develop and create new, biotechnology engineered drugs. Thus, the addition of new biotechnology firms ushered in a new business model based on strategic alliances. Strategic alliances have now become an industrial norm called open innovation. The author looks at the historical path of the biopharmaceutical industry, particularly in the United States. While the pharmaceutical industry’s main contributions to society are substantial, there are pressing challenges the industry must face, such as an increase in infectious disease outbreaks or the global aging population, which require new types of care, additionally, mental health care and prescription painkiller addiction are persistent issues with economic repercussions to both federal and local governments. This book presents a holistic view of the biopharmaceutical industry, putting it in a historical context. It will best serve those who are eager to learn about this dynamic, fast-evolving industry and who would like to tackle current biopharmaceutical industry issues in the United States and be prepared for future industry challenges.

The prescription drug market -- Proposed solutions for rising drug prices -- Measuring the value of prescription drugs -- Measuring drug value : whose job is it anyway? -- Institute for Clinical and Economic Review (ICER) -- Other US value assessment frameworks -- Do drugs for special populations warrant higher prices? -- Improving value measurement -- Aligning prices with value -- The path forward.

The obesity epidemic and the growing debate about what, if any, public health policy should be adopted is the subject of endless debates within the media and in governments around the world. Whilst much has been written on the subject, this book takes a unique approach by looking at the obesity epidemic from an economic perspective. Written in a language accessible to non-specialists, the authors provide a timely discussion of evolving nutrition policies in both the developing and developed world, discuss the factors influencing supply and demand of food supply, and review the evidence for various factors which may explain recent trends in diets, weight, and health. The traditional economic model assumes people choose to be overweight as part of a utility maximisation process that involves choices about what to eat and drink, how much time to spend on leisure, food preparation, and exercise, and choices about appearance and health. Market and behavioural failures, however, such as time available to a person, education, costs imposed on the health system and economic productivity provide the economic rationale for government intervention. The authors explore various policy measures designed to deal with the epidemic and examine their effectiveness within a cost-benefit analysis framework. While providing a sound economic basis for analysing policy decisions, the book also aims to show the underlying limits of the economic framework in quantifying changes in public well-being.

This volume analyzes group purchasing organizations (GPOs) and pharmacy benefit managers (PBMs) in order to better understand the significant roles that these entities play in the healthcare supply chain. It examines who they contract with, on what terms, and who they represent and answer to while charting their historical development. The analysis reveals that the current roles of both players have historical roots that explain why they behave the way they do. Finally, the book reviews the evidence base on the performance results of these two players. This work fills a void in our understanding about two important and controversial players in the healthcare value chain. Both organizations are cloaked in secrecy — partly by virtue of the private sector contracts they negotiate, partly by virtue of the lack of academic attention. Both play potentially important roles in controlling healthcare costs, albeit using contracting strategies and reimbursement mechanisms that arouse suspicion among stakeholders. This timely text explicates how these organizations arose and evolved to shed more light on how they really operate.

We live in an age in which expressive, informational, and technological subject matter are becoming increasingly important. Intellectual property is the primary means by which the law seeks to regulate such subject matter. It aims to promote innovation and creativity, and in doing so to support solutions to global environmental and health problems, as well as freedom of expression and democracy. It also seeks to stimulate economic growth and competition, accounting for its centrality to EU Internal Market and international trade and development policies. Additionally, it is of enormous and increasing importance to business. As a result there is a substantial and ever-growing interest in intellectual property law across all spheres of industry and social policy, including an interest in its legal principles, its social and normative foundations, and its place and operation in the political economy. This handbook written by leading academics and practitioners from the field of intellectual property law, and suitable for both a specialist legal readership and an intelligent but non-specialist legal and non-legal readership, provides a comprehensive account of the following areas: - The foundations of IP law, including its emergence and development in different jurisdictions and regions; - The substantive rules and principles of IP; and - Important issues arising from the existence and operation of IP in the political economy.

This book explores topics of importance to all who have an interest in economic methods for assessment of the efficacy and effectiveness of new cancer treatments and in regulatory measures relating to their marketing authorization and pricing. Targeted therapies and modern immunotherapy are placing a substantial strain on health care budgets. Regulation and economic methods to assess the parameters for establishing efficacy and effectiveness are therefore of prime importance. Payer authorities have to determine whether the use of these novel therapies yields clinical benefits that justify their increasing cost. In the simplest terms, cost-effectiveness analyses quantify the ratio between the extent to which an intervention raises healthcare costs and the extent to which it improves health outcomes. Rigorous cost-effectiveness analyses translate all health outcomes into quality-adjusted life years. On the other hand, in order to sustain innovation, price regulations must be coupled with efforts to ensure that drug companies are still able to recoup their investments in high-risk and high-costs research programs. Ultimately, decisions regarding health care expenditures are also a question of society’s willingness to pay.