Introduction To Market Access For Pharmaceuticals

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 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 correct purchasers, the drug will fail to reach its intended market. This practical guide, from the European Market Access University Diploma (EMAUD), helps readers draft a market access strategy for their product and prepare a positive healthcare environment that supports uptake of the product, including pricing considerations.

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.

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.

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.

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.

According to the World Health Organization, one-third of the global population lacks access to essential medicines. Should pharmaceutical companies be ethically or legally responsible for providing affordable medicines for these people, even though they live outside of profitable markets? Can the private sector be held accountable for protecting human beings' right to health? This thought-provoking interdisciplinary collection grapples with corporate responsibility for the provision of medicines in low- and middle-income countries. The book begins with an examination of human rights, norms, and ethics in relation to the private sector, moving to consider the tensions between pharmaceutical companies' social and business duties. Broad examinations of global conditions are complemented by case studies illustrating different approaches for addressing corporate conduct. Access to Medicines as a Human Right identifies innovative solutions applicable in both global and domestic forums, making it a valuable resource for the vast field of scholars, legal practitioners, and policymakers who must confront this challenging issue.