The Health Economics for Regenerative Medicine: How Payers Think and What That Means for Developers

Health technology assessment is an increasingly important part of the path to market for new technologies. The objective analytic methods and approaches to considering evidence are radically different to those adopted by regulatory authorities such as the Food and Drug Administration and European Medicines Agency. Developers who do not understand health technology assessment risk receiving regulatory approval for their technology only to find that they cannot command the price required to make a commercial return on their investment; Prochymal being only one example of many among early regenerative medicine products. In this chapter, we describe the paradigm of health technology assessment, with a specific focus on the use of economic evaluation to inform reimbursement decisions. We then consider the challenges that regenerative medicines are likely to face in achieving reimbursement and how developers can incorporate the objective of meeting reimbursement decision criteria into the design of the research and development programme.