Pharmaceutical Market Access in Developed Markets

Pharmaceutical Market Access in Developed Markets PDF

Author: Güvenç Koçkaya

Publisher: SEEd

Published: 2018-01-22

Total Pages: 324

ISBN-13: 8897419747

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Market access is the process by which a pharmaceutical company gets its product available on the market after having obtained a marketing authorization from a regulatory agency and by which the product becomes available for all patients for whom it is indicated as per its marketing authorization. It covers a group of activities intended to provide access to the appropriate medicine for the appropriate group of patients at the appropriate price (in most countries). Market Access may also be seen as activities that support the management of potential barriers, such as non-optimal price and reimbursement levels, the restriction of the scope of prescribing for the drug or complicated prescription writing or funding procedures. Since there are cultural differences among countries, any Market Access strategy needs to be culturally sensitive. Pharmaceutical Market Access in emerging markets has been extensively discussed in our previous book, published in 2016. The present book focuses on developed markets with the goal of helping students, academics, industry personnel, government workers, and decision makers understand the environment in developed markets.

Pharmaceutical Market Access in Emerging Markets

Pharmaceutical Market Access in Emerging Markets PDF

Author: Güvenç Koçkaya

Publisher: SEEd

Published: 2016-10-20

Total Pages: 238

ISBN-13: 889741964X

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The definition of Market Access was first reported by the World Trade Organization as “to open markets for trade and improve transparency, reciprocity, and non-discrimination in international trade”. Pharmaceutical Market Access is different and it could be defined as achieving the optimal price for a product or service and/or the maximum reimbursement for the approved target population with no restrictions on funding for the medical technology. By the way, Market Access is not only the market authorization, but it also includes overlapping activities like pricing, health technology assessment, formulary, and reimbursement. Market Access is one of the most important activities for pharmaceutical companies and emerging countries represent an important opportunity for launching new products. It was reported that the Compounded Average Growth Rate (CAGR) was 6.0% in the period 2011-2017, and expected sales exceeding 1.1 trillion USD by 2017 for emerging countries. Furthermore, CAGR 2008-2012 for recently launched pharmaceuticals were 9.8% for emerging countries and 1.5% for the top 8 developed countries. The Market Access processes in the most important emerging countries in the selected regions are defined in this book with the aim to help local experts, local government officers, headquarter managements, and everyone who want to learn more about healthcare system and health policies pathways of Market Access, mapping and structure of decision makers, challenges and catalyzers for Market Access in the emerging countries.

Introduction to Market Access for Pharmaceuticals

Introduction to Market Access for Pharmaceuticals PDF

Author: Mondher Toumi

Publisher: CRC Press

Published: 2017-01-12

Total Pages: 310

ISBN-13: 1315314584

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Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers’ needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University. Key Features: The first guide to market access for pharmaceuticals based on tested teaching materials Addresses both pharmaceutical and vaccine products Includes case studies and scenarios Covers market access consdierations for Western Europe, the USA, Japan and China Explains the impact the changing healthcare market will have on your product

Equitable Access to High-Cost Pharmaceuticals

Equitable Access to High-Cost Pharmaceuticals PDF

Author: Zaheer-Ud-Din Babar

Publisher: Academic Press

Published: 2018-02-27

Total Pages: 238

ISBN-13: 0128119624

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Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs Incorporates existing guidelines and recommendations by international organizations Compares and contrasts how different countries fund and police high-cost drug access Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing Reviews novel pharmaceuticals of current research interest

Global Pharmaceuticals

Global Pharmaceuticals PDF

Author: Adriana Petryna

Publisher: Duke University Press

Published: 2006-03-15

Total Pages: 314

ISBN-13: 9780822337416

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DIVAnthropological study of the globalization of pharmaceuticals and its effects on local cultures, health, and economics./div

Making Medicines Affordable

Making Medicines Affordable PDF

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-03-01

Total Pages: 235

ISBN-13: 0309468086

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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.

The Price of Global Health

The Price of Global Health PDF

Author: Ed Schoonveld

Publisher: Routledge

Published: 2016-02-24

Total Pages: 494

ISBN-13: 131701930X

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Public debate on the rising cost of new biotechnology drug treatments has intensified over the last few years as healthcare budget pressures have mounted under a strained economy. Meanwhile, the demand for new, effective medical and drug treatments continues to rise as unhealthy lifestyles cause further increases in diabetes and cardiovascular disease. Global drug pricing is one of the most hotly debated yet least understood aspects of the pharmaceutical industry. How should drug prices be set and what does it mean for patients? Why do governments increasingly get involved, and what is its impact on the global competitive environment? How can a life-saving industry have a poorer image than gun and tobacco industries, whose products are associated with death? Ed Schoonveld explains how pharmaceutical prices are determined in a complex global payer environment and what factors influence the process. His insights will help a wide range of audiences, from healthcare industry professionals to policy makers and the broader public, to gain a better understanding of this highly complex and emotionally charged field. The Price of Global Health is recognized as a valued and unique reference book that covers a complete array of topics related to global pharmaceutical pricing. It contains an in-depth but straightforward exploration of the pharmaceutical pricing strategy process, its underlying market access, general business and ethical considerations, and its implications for payers, physicians and patients. It is a much-needed and invaluable resource for anybody interested or involved in, or affected by, the development, funding and use of prescription drugs. In particular, it is of critical importance to pharmaceutical company executives and other leaders and professionals in commercialization and drug development, including marketing, business development, market access and pricing, clinical development, drug discovery, regulatory affairs, health outcomes, market research and public affairs. The second edition includes new chapters on payer value story development, oncology, orphan drugs and payer negotiations. Furthermore, many country chapters have been substantially updated to reflect changes in the healthcare systems, including the Affordable Care Act in the US, AMNOG in Germany, medico-economic requirements in France and many other country-specific changes. Lastly, almost every chapter has been updated with new examples and illustrations.

The Oxford Handbook of the Economics of the Biopharmaceutical Industry

The Oxford Handbook of the Economics of the Biopharmaceutical Industry PDF

Author: Patricia M. Danzon

Publisher: Oxford University Press

Published: 2012-04-12

Total Pages: 624

ISBN-13: 0199909261

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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.

A Practical Approach to Pharmaceutical Policy

A Practical Approach to Pharmaceutical Policy PDF

Author: Andreas Seiter

Publisher: World Bank Publications

Published: 2010-06-17

Total Pages: 238

ISBN-13: 9780821383872

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This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.