Health technology assessments and real-world evidence: tell us what you want, what you really, really want

Summary

Health Technology Assessment (HTA) involves the synthesis of a broad body of clinical, humanistic and economic evidence in order to determine the relative benefit of health technologies. Guidelines set out by HTA bodies seek to provide general guidance on the methodological standards for evidence to be submitted for their consideration, and some insight into the relative value that will be assigned to different types of evidence during decision-making. The extent to which specific pieces of evidence influence HTA decisions appears to be subjectively determined by the relationship between the body of evidence available for a specific technology and the values, preferences and constraints of a given HTA body [1]. As such, a single piece of evidence might influence decision making for a single product very differently across different HTA bodies and the same type of evidence may impact the assessment of different technologies by the same HTA body differentially. Given these nuances, alongside organizational experience, manufacturers must rely not only on formal guidelines to support their decision making around evidence generation activities, but also on critical review of the outputs of HTAs carried out for other products in a similar therapeutic area and/or with a comparable evidence base. It is therefore important that clarity regarding the relative value of different pieces of evidence to the decision-making process is provided in all of these outputs.