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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
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.
This concise and reader-friendly overview of WTO law is essential reading for anyone needing an introduction to this complex field.
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.
Digital healthcare is heterogeneous along the entire treatment pathway, ranging from monitoring applications and artificial-intelligence-based diagnostics, to support for virtual reality surgery. Since the introduction of the Digital Health Act in Germany in early 2020, there has been a push toward digital innovative solutions, especially in the outpatient sector. This book analyzes current digital health law from an economic perspective, combining theory with real-world applications. It examines both the incentives and market access pathways for digital solutions and the price effects brought about by the new regulatory framework in Germany. Further, it discusses the difficulties in pricing due to the monopolistic BfArM register and negotiations with the association of all German health insurance companies. The book addresses a wide range of topics, including incentives for innovation, specifics of digital health applications, reimbursement and financing options for digital health solutions. Lastly, it presents an outlook for the future and a comparison between Germany and other countries, namely the USA and Japan. Given its scope, this book will appeal to scholars of health economics, healthcare management and public health, as well as practitioners and professionals in the public health sector.
Starting from the observation that the establishment of free trade as such will substantially impact upon economic development, the different contributions focus on the potential contribution of non-traditional aspects of EPAs.
The major advances in the field of biotechnology and molecular biology in the twenty-first century have led to a better understanding of the pathophysiology of diseases. A new generation of biopharmaceuticals has emerged, including a wide and heterogeneous range of innovative cell and gene therapies. These therapies aim to prevent or treat chronic and serious life-threatening diseases, previously considered incurable. This book describes the evolution and adaptation of the regulatory environment to assess these therapies in contrast with the resistance of health technology assessment (HTA) agencies and payers to acknowledge the specificity of cell and gene therapies and the need to adapt existing decision-making frameworks. This book provides insights on the learnings from the experience of current cell and gene therapies (regulatory approval, HTA, and market access), in addition to future trends to enhance patient access to these therapies. Key Features: Describes the potential change of treatment paradigm and the specificity of cell and gene therapies, including the gradual move from repeated treatment administration to one-time single administration with the potential to be definite cure Highlights the challenges at the HTA level Discusses the affordability of future cell and gene therapies and the possible challenges for health insurance systems Provides potential solutions to address these challenges and ensure patient access to innovation while maintaining the sustainability of healthcare systems
This is primarily a textbook for graduate and upper-level undergraduate students of law. However, practising lawyers and policy-makers who are looking for an introduction to WTO law will also find it invaluable. The book covers both the institutional and substantive law of the WTO. While the treatment of the law is often quite detailed, the main aim of this textbook is to make clear the basic principles and underlying logic of WTO law and the world trading system. Each section contains questions and assignments, to allow students to assess their understanding and develop useful practical skills. At the end of each chapter there is a helpful summary, as well as an exercise on specific, true-to-life international trade problems.