Authorization and Financing Situation in Spain of the New Medicines and Indications Authorized by the European Commission in the Period 2021-2023

OBJECTIVES: To evaluate key milestones and timing in the different stages from European Medicines Agency (EMA) application submission to Spanish reimbursement of new medicines and indications (NMI) authorized by the European Commission (EC) in the period 2021-2023.

METHODS: NMI authorized by the EC following the centralized procedure in the period 2021 to 2023 were analyzed. The data for the analysis were obtained from public online databases such as the Spanish Agency for Medicines and Health Products (AEMPS) or the EMA website. A descriptive analysis of different variables of interest originating from the beginning of the EMA application submission to the end of the pricing and reimbursement process in Spain was carried out.

RESULTS: Seventy-six percent of the NM authorized by the EC had the AEMPS authorization in the period under evaluation. The mean time from EC authorization to AEMPS authorization was 3,7 months. Fifty-four percent of the NMI evaluated by the Interministerial Commission on Medicines Prices (CIPM) obtained reimbursement in Spain in the first evaluation. The mean time from EC/AEMPS authorization to CIPM first evaluation was 10,3 months. The budgetary impact was the main reason (74%) for not reimbursing. Of the total NMI authorized by the EC, 37% obtained a published IPT. The average time between IPT initiation and Phase 1 draft was 11,2 months.

CONCLUSIONS: It is crucial to have information on the main timelines and stages that condition access to medicines in Europe and Spain to better understand this process. This understanding is essential for identifying the various factors that influence the availability and accessibility of medicines and for making better decisions on strategies.