Gap between Payers and Regulators

Medicine regulators are entities that typically do not consider the cost of treatments, but rather focus on internal validity of data from clinical trials such as efficacy, safety, and the phar­ maceutical quality. For the purpose of this chapter, we will not consider the quality that has to be granted to gain a mar­ keting authorization (MAu). In contrast, payers are generally entities that finance or reimburse the cost of health products and services. They tend to focus on external validity of clini­ cal trial data, comparative effectiveness, real­life treatment pathways, and cost­effectiveness. These two authorities have often different perspectives on uncertainty and risk.