A comprehensive review of the challenges that exist in patient accessibility to advanced therapy medicinal products (ATMPs), presenting clinical trials, marketing authorization, HTA, pricing, reimbursement, affordability, payment and partnership agreements of RMs and commercialisation. Specfically, we investigated how COVID-19 has impacted the RMs industry by elaborating on the disruptions it caused but also the new opportunities it brought. The ultimate goal of this work is to make strategic recommendations for manufacturers and decisions-markers on effective strategies to address the above obstacles and facilitate patient access to promising regenerative medicines. Features : Regenerative medicine (RM) is an emerging interdisciplinary field aiming to replace or regenerate human cells, tissues, or organs in order to restore normal functions. Regenerative medicine holds the promise of revolutionising treatment in the 21st century. RMs bring new hope for some previously untreatable diseases, as well as holding promise for the treatment of common chronic diseases. Rapid advancements in biotechnology and improved understanding of disease pathophysiology have attracted tremendous interests in the development of RMs. Discusses the high cost of RMs which may challenge the sustainability of healthcare insurers (public and private).

A comprehensive review of the challenges that exist in patient accessibility to advanced therapy medicinal products (ATMPs), presenting clinical trials, marketing authorization, HTA, pricing, reimbursement, affordability, payment and partnership agreements of RMs and commercialisation. Specfically, we investigated how COVID-19 has impacted the RMs industry by elaborating on the disruptions it caused but also the new opportunities it brought. The ultimate goal of this work is to make strategic recommendations for manufacturers and decisions-markers on effective strategies to address the above obstacles and facilitate patient access to promising regenerative medicines. Features : Regenerative medicine (RM) is an emerging interdisciplinary field aiming to replace or regenerate human cells, tissues, or organs in order to restore normal functions. Regenerative medicine holds the promise of revolutionising treatment in the 21st century. RMs bring new hope for some previously untreatable diseases, as well as holding promise for the treatment of common chronic diseases. Rapid advancements in biotechnology and improved understanding of disease pathophysiology have attracted tremendous interests in the development of RMs. Discusses the high cost of RMs which may challenge the sustainability of healthcare insurers (public and private).

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.

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.

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

1) Discusses the affordability of future therapy and the possible challenges for health insurance systems 2) Highlights the gradual move from repeated treatment administration to one single administration with potential for a definite cure 3) Describes the potential change of paradigm which will challenge all payers and may question the sustainability of our health care systems

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.