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Market entry agreements (MEA) for pharmaceuticals have become extremely popular and widespread geographically. Emerging countries that have not yet begun to introduce MEAs are now actively engaged in doing so. This book examines the concept of MEAs, detailing how depreciation of some specific regenerative therapies through intangible asset amortization is unavoidable.The authors provide a historical vision of the development of MEAs with experiences, failures, and successes that have shaped the evolution and place of MEAs in access to pharmaceuticals. They provide an extensive review of MEA typology and propose a new one that is pragmatic and actionable.FEATURES Discusses the affordability of future therapies and the possible challenges for health insurance systems Addresses the practical and applied issue of market access and includes the most up-to-date developments, such as the Pelosi bill Describes the potential paradigm change that will challenge all payers and may question the sustainability of our health care systems Highlights the gradual move from repeated treatment administration to a single administration with the potential for a definite cure Managed Entry Agreements and Funding for Expensive Therapies provides invaluable information to all stakeholders involved in market access and to students in the field.

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