Health Technology Assessment and Its Interface with Regulation, Policy and Management

Abstract

The purpose of health technology assessment (HTA) is to assist those who make key decisions regarding the allocation of scarce healthcare resources. However, although considerable attention has been paid to developing appropriate methods for conducting HTA, much less attention has been paid to ensuring that those conducting HTA are sufficiently well-connected to, and perceived as being relevant by, those making the resource allocation decisions. Therefore, this chapter explores how those conducting HTA can interface better with the key decision makers. Three groups in particular are discussed: regulators, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), who give approval for new health technologies to enter the market; policy makers, who influence the diffusion and use of health technologies by providing reimbursement or issuing guidance; and health service managers, who are responsible for implementing policies and managing the day-to-day use of health technologies.