Main description:

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

Contents:

Chapter 1 Introduction to cell and gene therapies concepts and definitions in the US and EU .................................................... 1

Chapter 2 Cell and gene therapies: genuine products and potential for dramatic value ........................................... 19

Chapter 3 Cell and gene therapies: regulatory aspects in the US and EU ............................................................................ 31

Chapter 4 The need for new HTA reference case for cell and gene therapies ............................................................................ 59

Chapter 5 How to mitigate uncertainties and HTA risk-averse attitude? ............................................... 91

Chapter 6 Cell and gene therapies funding: challenges and solutions for patients' access ........................................ 101

Chapter 7 Conclusion ................................................................................ 129