1st Edition

Managed Entry Agreements and Funding for Expensive Therapies

By Mondher Toumi, Szymon Jarosławski Copyright 2022
    179 Pages 4 B/W Illustrations
    by CRC Press

    179 Pages 4 B/W Illustrations
    by CRC Press

    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.


    • 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.

    1. Introduction to Managed Entry Agreements

    2. Definition and Classification of MEAs

    3. From Coverage with Evidence Development to Individual Performance-Based Agreements in Italy

    4. Coverage with Evidence Development for Multiple Sclerosis Drugs in the UK: A "Costly Failure"?

    5. Country Comparison of the Implementation of Managed Entry Agreements

    6. Novel Funding Models for Expensive Therapies

    7. Managed Entry Agreement for Cell and Gene Therapies


    Mondher Toumi is M.D. by training, M.Sc. in Biostatistics, and in Biological Sciences (option pharmacology) and Ph.D. in Economic Sciences. Mondher Toumi is Professor of Public Health at Aix-Marseille University. After working for 12 years as Research Manager in the department of pharmacology at the University of Marseille, he joined the Public Health Department in 1993. In 1995 he embraces a carrier in the pharmaceutical industry for 13 years. Toumi was appointed Global Vice President at Lundbeck A/S in charge of health economics, outcome research, pricing, market access, epidemiology, risk management, governmental affairs and competitive intelligence. In 2008, he founded Creativ-Ceutical, an international consulting firm dedicated to support health industries and authorities in strategic decision-making. In February 2009 he was appointed Professor at Lyon I University in the Department of Decision Sciences and Health Policies. The same year, he was appointed Director of the Chair of Public Health and Market Access. He launched the first European University Diploma of Market Access (EMAUD) an international course already followed by almost 350 students. Additionally, he recently created the Market Access Society to promote education, research and scientific activities at the interface of market access, HTA, public health and health economic assessment. He is editor in Chief of the Journal of Market Access and Health Policy (JMAHP) which was just granted PubMed indexation. Toumi is also visiting Professor at Beijing University (Third Hospital). He is a recognized expert in health economics and an authority on market access and risk management. He has more than 250 scientific publications and communications, and has contributed to several books.