OBJECTIVES: To identify any gaps when applying evidence-informed deliberative frameworks in the health technology assessment (HTA) process for medicines in Spain.

METHODS: Assessment of the level of implementation of deliberative processes in Spain across the lifecycle of a medicine using the framework of evidence-informed deliberative process in HTA from Oortwijn et al. (2021) and the subsequently published checklist (Oortwijn et al. 2022). This is applied to the process for conducting therapeutic positioning reports on medicines published by the Spanish Ministry of Health and the Spanish Medicines and Healthcare Products Regulatory agency (2020), and the process for evaluating and decision making on pricing and reimbursement.

RESULTS: The application of evidence-informed deliberative process for evaluations of medicines in Spain is limited in most of the HTA steps. There is no stakeholder participation in the advisory committees beyond decision-makers, except for the assessment step in which experts nominated by the different regions (mostly clinical) participate. Consultation is conducted between assessment and appraisal with scientific societies, patient organisations and industry sponsors invited to provide comments in the draft therapeutic positioning report. Information is used in the other steps but is very limited in the appeal and monitoring and evaluation steps. Although the process and methods for developing the therapeutic positioning reports are published, terms of reference for the deliberative process are absent. In the evaluation and decision-making on pricing and reimbursement, participation is limited to policy makers and only final information is published.

CONCLUSIONS: Spain is far from applying evidence-informed deliberative process for HTA evaluations of medicines. Contextual factors such as the fragmentation of the healthcare system and prominence of certain stakeholders such as clinicians and healthcare managers may have hampered the application of deliberative frameworks including other stakeholders. This study highlights areas for improving the application of evidence-informed deliberative HTA processes in Spain.