Presentation (CTI)

OBJECTIVES: Pharmaceutical reimbursement is key to ensuring timely patient access and the sustainability of healthcare systems. The rise of therapeutic innovation, market competition, and personalized medicine has intensified pressure on health systems, highlighting the need to reassess reimbursement models to ensure resource efficiency and equitable access. This study analyzes the evolution of pharmaceutical pricing and reimbursement decisions in Spain over the past decade.
METHODS: The Spanish Ministry of Health’s BIFIMED database was used to identify all medicines reimbursed between 2015-2024. Records were processed in Excel and classified by medicine type and reimbursement agreement. A descriptive analysis was conducted to explore distribution and temporal trends.
RESULTS: Among 8,588 treatments reimbursed over the study period, the analysis focused on 1,353 medicines (15.8%) that were innovative (i.e., those that were not generics, biosimilars or different presentations to avoid duplication). Of these, 215 were biologics (15.9%). Regarding dispensing channels, 42.1% (n=569) were designated for hospital dispensing and 57.9% (n=784) for community pharmacy dispensing, with 14.8% (n=116) requiring prior authorization. Orphan drugs accounted for 6.5% (n=88), rising notably from 1 orphan drug reimbursed in 2015 to 19 in 2024, with 97.7% assigned to hospital dispensing. A notable increase in reimbursement decisions subject to special funding conditions (SFC) was observed, rising from 8.7% in 2015 to 45.9% in 2024. Among these funding conditions, 62.8% were related to monitoring and traceability systems, while 23.8% were financial agreements.
CONCLUSIONS: Over the past decade, Spain has reinforced access to innovative treatments, including a growing number of biologics and orphan drugs, many dispensed at hospitals. The increase in SFC suggests a shift toward greater financial oversight and clinical accountability. Generating robust evidence to support clinical value, predict the economic impact through advanced modelling techniques and pharmacoeconomic analysis and demonstrate real-world outcomes will be essential to sustaining access for therapies subject to complex reimbursement process.