OBJECTIVES: Detailed, publicly available information on the process and methods for health technology assessment (HTA) of medical technologies (MTs) can be difficult to find. Our objective was to understand the process and methods used for HTAs of MT in Spain.
METHODS: Following a search of HTA websites, participation in an online survey was requested from the Spanish Network of Agencies for HTA and Services of the NHS (RedETS), the Agencia Espaňola de Medicamentos y Productos Sanitarios (AEMPS), and 3 regional members of RedETS. The survey requested information on the MT selection process, types of MT evaluated, and types of evidence considered within the HTA process. Quantitative and qualitative data were obtained and collated in Excel. The organisation websites were reviewed to supplement the survey.
RESULTS: The initial searches revealed a centralised MT HTA process through AEMPS and RedETS, followed by Comisión de Prestaciones, Aseguramiento y Financiación (CPAF) for an economic assessment and Consejo Interterritorial del Sistema Nacional de Salud (CISNS) as the key decision-maker for HTA recommendations. Only the Agency of Health Quality and Assessment of Catalonia (AQuAS) completed the online survey, providing information to supplement that on their website. The responses confirmed that AQuAS can evaluate invasive and non-invasive devices, diagnostics, digital technologies such as apps, and other programs of care. AQuAS’ dedicated process for assessing MTs considers clinical and economic data and data from the public domain.
CONCLUSIONS: HTA processes for MTs in Spain are centralized through AEMPS and the RedETS consortium, which work together at the national level. Limited information was available on the Spanish HTA organisation websites, but contact from AQuAS revealed additional details for the approach in Catalonia. MT companies should be prepared to contact HTA agencies directly to obtain necessary information to inform evidence generation, market access strategies, and HTA submission plans.
