Guidance for the use of real-world data in health technology assessment in Spain

In March 2025, the Health Sciences Institute in Aragon (IACS) released a document that provides guidance on incorporating real-world data (RWD) into health technology assessment (HTA), focusing on the preadoption phase for evaluating new technologies in the Spanish Network of HTA Agencies (RedETS) framework. It outlines a workflow aligning with RedETS practices, identifying key milestones where RWD adds value and offering methods and tools to integrate RWD into decision models.

By replicating an existing HTA report with RWD, the document demonstrates how RWD enhances analyses by offering insights into patient profiles, healthcare pathways, comorbidities, and resource utilization. However, it acknowledges challenges in data availability and emphasizes the need for further work to refine the modeling phase.

The report highlights the importance of collaboration with health authorities to improve data access and calls for expanding training programs to equip HTA analysts with RWD tools and modeling techniques. It also notes emerging technologies like natural language processing and the development of the Spanish and European Health Data Spaces, which could facilitate data access and analysis.

While full implementation of the proposed workflow may be challenging, certain elements, such as exploratory data analysis combined with systematic reviews, are already feasible. The document concludes that advancing RWD-driven HTA methods requires interdisciplinary collaboration, technological innovation, and capacity building, ultimately enhancing evidence-based decision-making in RedETS.

See the full details in Spanish here.

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