Fundamentals of Market Access for Pharmaceuticals

‘Because at the heart of the apparent conflict between public health concerns and capitalistic interests, market access for pharmaceuticals is largely driven by political considerations, the difference with usual consumer goods being that pharmaceuticals are saving lives or years of life in good health‘. Pharmaceuticals are mainly sourced by companies investing in costly R&D and production at their own risks to make them globally available. However, access for patients in need can be restricted due to insufficient medical resources and/or unaffordability. The dilemma between rewarding innovation with prices in line with value and risks for companies and ensuring affordability for patients or health insurances has become critical for all stakeholders, with political and economic implications. The development of universal health coverage puts pressure on governments to control directly or indirectly reimbursement and prices of pharmaceuticals, whereas the flow of innovations addressing infectious, chronic, and life-threatening diseases, thanks to accelerated scientific progress, is growing constantly. Management of pharmaceutical health care expenditure approach varies according to the historical, cultural, and economic backgrounds that contribute to building each health care system, and companies are confronted with a very complex environment to launch their new drugs and manage their lifecycle until loss of patent. This book explores the different models of health care systems (e.g., Europe, United States, Japan, China) and the criteria and processes for decision making in coverage and pricing of pharmaceuticals. It also provides the analytic tools that are used to inform the decisions, and how market access strategy can be integrated in the product life cycle. Short case studies related to specific disease areas or methods are supporting exposed concepts and methods. This book targets primarily students, but may prove useful to industry or insurance executives and eventually public decision makers with interest in the field: all will find relevant insights and sources to dig deeper into the topic. The content has been developed partially through a well received teaching program at CEIBS MBA since 2020.