Presentation (CTI)

OBJECTIVES: To describe the time from authorization by the Spanish Agency of Medicines and Medical Devices (AEMPS) to the first pricing and reimbursement (P&R) assessment and to the last available decision of the Interministerial Commission on Drug Pricing (CIPM) in Spain, and to explore differences according to reimbursement decision.
METHODS: A descriptive analysis was conducted using a repository of medicines authorized through the European centralized procedure. The study subgroup included new medicines with a first CIPM agreement in 2025. Time from AEMPS authorization to the first assessment and to the last available CIPM date was calculated in days and converted into months (days/30.44). Results were summarized using the median and stratified by reimbursement outcome.
RESULTS: Thirty-three medicines met the inclusion criteria. The median time from AEMPS authorization to the first P&R assessment was 258 days (8.5 months). Based on the first CIPM agreement, 15 medicines (45%) were reimbursed and 18 (55%) were not reimbursed. Median time was shorter for reimbursed than for non-reimbursed medicines (211 vs 298 days; 6.9 vs 9.8 months, respectively). Considering the last available CIPM decision, 26 medicines (79%) were reimbursed and 7 (21%) were not reimbursed. Median time to that decision was 314 days (10.3 months), with median times of 278.5 days (9.2 months) for reimbursed medicines and 455 days (15.0 months) for non-reimbursed medicines.
CONCLUSIONS: In this subgroup of medicines with a first CIPM agreement in 2025, time to both the first P&R assessment and the last available CIPM decision exceeded 180 days. Delays were longer for non-reimbursed than for reimbursed medicines.