Spain has published Royal Decree 415/2026[1], setting out a new national framework for health technology assessment (HTA). The Decree marks a shift from a more fragmented assessment landscape, previously centred on medicine-specific therapeutic positioning reports (TPRs) and separate non-pharmaceutical technology assessments, towards a more formalised, system-wide and European Union (EU)-aligned HTA process.
To inform decisions on pricing, reimbursement, conditions of use, adoption or disinvestment within the Spanish National Health System (SNS), the Decree enters into force on 18 June 2026.
For manufacturers, the Decree raises important questions for launch planning in Spain. How will the new framework differ from the previous TPR and Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS)-based approach? How will Spain use EU Joint Clinical Assessment (JCA) outputs while still making its own national value judgements? What role will economic and budget evidence play? And how should companies prepare for the new assessment timelines? The below analysis explores the key changes introduced by the Decree and the practical steps manufacturers should consider ahead of implementation.
Download Remap's full expert analysis to explore:
- How Spain’s new HTA framework changes evidence requirements for manufacturers
- The role of EU Joint Clinical Assessments (JCA) and where national evidence will still be required
- Why economic evaluation and budget impact are becoming increasingly important in Spanish decision-making
- Practical considerations for launch planning, evidence generation, pricing and reimbursement strategy