Real-world evidence (RWE) is a ubiquitous conversation topic in discussions on the current health technology assessment (HTA) landscape for biotech and biopharma assets. By now it is widely known that RWE is an unavoidable part of drug development and should be given thorough consideration, ideally early on; a simple online search for “the importance of real-world evidence in HTA” reaps thousands of results. High-quality practice guidelines lead the way to explaining how to develop robust RWE, e.g., through the Innovative Medicines Initiative’s (IMI) GetReal project, the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) RWE task force, and other instructional articles.1,2 Despite the availability of such guidance, often health technology assessment bodies, payers, and even regulators do not regard submissions of real-world data or evidence as manufacturers hoped they would.
The aim of this article is to discuss the current use of real-world data and evidence in HTA and payer appraisals, its potential role in lifecycle management, and how the early dialogue provided by Integrated Scientific Advice (ISA) engagement can be used as a key tool in real-world evidence generation planning.
