Health Technology Assessment of Medical Devices in Spain From 2012 to 2024

OBJECTIVES: To explore how the health technology assessment (HTA) of medical devices has evolved in Spain since the creation of the Spanish Network for Health Technology Assessment of the National Health System (RedETS) in 2012.

METHODS: RedETS encompasses eight public HTA bodies that cooperate using common methodologies. RedETS reports published from 2012 to 2024 were extracted from its website [28th May 2024]. Extracted data included the report title, the agency and authors behind the report, and the year of publication. HTA reports were then classified considering the target therapeutic area, disease, population, and technology/intervention.

RESULTS: RedETS has published 523 reports since its creation (2012-2024), averaging 40 reports per year. The HTA bodies' contributions were the following: SESCS (18.5%), AETSA (17.6%), AQuAS (17.4%), OSTEBA (13.2%), AVALIA-T (9.9%), ISCIII (9.4%), UETS-MADRID (9.0%), and IACS (5.2%). Almost one in every five HTA reports was in oncology (17.4%), followed by cardiology (12.0%). Approximately one in ten reports studied the paediatric population. A total of 40 reports focused on screening, the majority related to oncology (25.0%) and neonatal or paediatrics (55.0%). Analyses of the HTA reports per therapeutic area and agency reveal some specialization patterns, with the SESCS conducting 48.0% of the endocrinology reports, and AETSA 35.7% of the obstetrics and gynaecology ones. A diverse range of technologies/medical interventions were assessed, from complementary and alternative medicine techniques to digital and artificial intelligence-based medical devices.

CONCLUSIONS: The creation of RedETS marked a new era for HTA in Spain, bringing together different regions into a national network. As we prepare to enter a new era, with the development of European joint clinical assessments on drugs, in vitro diagnostics, and high-risk medical devices, it is important to understand how HTA has evolved so far in Spain and monitor the change over the upcoming years.