Presentation (CTI)

OBJECTIVES: In Spain, medicines may undergo a centralized assessment at the European level, followed by national evaluation and, in some cases, an additional appraisal at the regional level (e.g., Catalonia), within a decentralized healthcare system where regional authorities act as final payers. This study aimed to analyze the evaluation reports from the Pharmacotherapeutic Harmonisation Program of the Catalan Health Service (CatSalut).
METHODS: All appraisal reports published on the CatSalut website between January 1 and December 31, 2025, were reviewed. The analysis primarily examined the economic parameters reported for the assessed medicines, and a qualitative descriptive analysis was conducted.
RESULTS: A total of 38 reports published in 2025 were identified, of which 34 were included in the analysis after excluding those with insufficient information. Most appraisals (82%) concerned hospital-use medicines, with the remainder covering primary care or specialized care medicines. Around one-fifth of the reports indicated that adoption of medicine would generate cost savings, whereas 79% showed a positive budget impact, ranging approximately from €0.3 million to €76 million over a 3-year period. Cost-effectiveness analyses were not submitted in 68% of cases; 26% included analyses suggesting the medicine could be cost-effective; and 6% analyses had major limitations. The reports did not include incremental cost-effectiveness ratio results, nor did they specify whether any type of risk-sharing agreement had been implemented. Regarding timelines, regional publication involved time after national reimbursement approval in Spain: 15% of reports were published within 1 year, 50% between 1 and 2 years, and 35% between 2 and 3 years.
CONCLUSIONS: Multiple layers of assessment potentially delay patient access to innovative medicines. Economic evaluation is expected to play an increasingly important role in regional decision-making in Catalonia, particularly in the context of evolving Health Technology Assessment policy frameworks at the European, national, and regional levels.