Authors' results and conclusions: This document provides guidance specifically tailored to the most common case of HTA in RedETS production, which is assessing the inclusion of a new technology in the benefits/services basket during the preadoption phase. We have outlined a workflow consistent with RedETS practices, highlighting the key points and milestones where RWD can add value. Additionally, we offer guidance on methods and tools to effectively incorporate RWD at each stage, from defining data requirements to analysis, with a particular emphasis on building decision models. While these instructions primarily apply to the preadoption phase, many of them are applicable to other stages of the technology’s life cycle. To illustrate the potential of RWD, we have replicated an existing HTA report, incorporating RWD at relevant points in the workflow. Through this exploration, we demonstrate how RWD provides valuable information about real patient profiles, their healthcare journeys, their actual health status (including comorbidities) that may impact health outcomes, and insights into the utilisation of healthcare resources. This demonstrates the potential of RWD to enhance HTA analyses, offering a more comprehensive understanding of the context-specific patient population and the potential impact of a new health technology. We also acknowledge the limitations encountered regarding data availability and emphasize the need for further work to implement the modelling phase. In this spirit, this methodological handbook is intended to be continuously updated based on the cumulative experience gained from producing full HTA reports using RWD, as planned for instance within the RedETS 2023 work plan. While we recognize that implementing the full workflow outlined in this handbook may be challenging at present, certain elements are already suitable for inclusion in RedETS assessments. For example, exploratory data analysis can be combined with systematic reviews and traditional modelling techniques to enhance the contextual value of RedETS assessments for decision-making. The task ahead holds great hope but requires overcoming some challenges for full deployment of RWD-driven methods. This entails fostering collaboration with health authorities and designated data holders at the national and regional levels to address data access challenges across RedETS agencies. In the short term, it is essential to include data scientists in assessment teams and provide appropriate capacity building, expanding the continuous training of HTA analysts to encompass RWD tools and modelling techniques. It is worth noting that technology is continuously evolving, and we anticipate the emergence of new approaches, such as natural language processing, to leverage the information generated in the healthcare system, thereby expanding the data sources available to bridge existing gaps. Additionally, the development of the Spanish Healthcare Data Space and European Health Data Space may simplify some data access and analysis processes described in this document. In conclusion, our exploration of using RWD for HTA in the preadoption phase has uncovered limitations but has also highlighted immediate options for better informing evidence-based decision-making. This exercise points the way forward by embracing advancements in RWD analysis and modelling techniques, fostering interdisciplinary collaboration, and building capacity to fully harness the potential of RWD in HTA. By doing so, we can strengthen RedETS’ ability to provide robust and comprehensive assessments, ultimately improving decision-making.

Project Status: Completed

Year Published: 2025

URL for published report: https://www.iacs.es/wp-content/uploads/2025/03/00_IACS_RWD-HTA_E3_DEF_EN.pdf

English language abstract: An English language summary is available

Publication Type: Other

Country: Spain

DOI: https://doi.org/10.46994/ets_42

Organisation Name: Health Sciences Institute in Aragon (IACS)

Contact Address: Avda, San Juan Bosco, 13, planta 2

Contact Name: María Pilar Calvo Pérez

Contact Email: direccion.iacs@aragon.es