Analysis of IPT Developed for the New Medicines and Indications Authorized by the European Commission During the 2021-2023 Period

OBJECTIVES: To describe the characteristics of the therapeutic positioning reports (IPT) developed by the Spanish Agency of Medicines and Health Products (AEMPS) for the new medicines and indications (NMI) authorized by the European Commission (EC) in the 2021-2023 period.

METHODS: NMI authorized by the EC between 2021 and 2023 that included information regarding the Spanish IPT 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 European Medicines Agency (EMA) website. A descriptive analysis of different variables of interest related to the IPT process was conducted. The main variables evaluated were the total number of IPT, the elaboration time, the therapeutic groups evaluated, the positioning conclusions and the relationship between the reimbursement status and the positioning conclusions.

RESULTS: In the period under evaluation, 180 IPT were published for the 484 NMI authorized by EC. The average time between IPT initiation and Phase 1 draft was 11 months and the average time between initiation and publication was 18 months. Twenty-seven percent of the IPT established restrictions on use concerning the approved indications. Forty-five percent (n=81) of the IPT published for the NMI evaluated were in oncology, followed by eight percent (n=15) in neurological diseases. Fifty-eight percent of the reimbursed NMI were positioned as treatment of choice or aligned with existing alternatives.

CONCLUSIONS: The main aim of IPT was to establish them as a pivotal tool for positioning and economically evaluating medicines within the Spanish National Health System, optimizing the evaluation process, and reducing IPT elaboration times. From the analysis conducted (based on the public information available), it takes between 1-2 years for the IPT to be published and thus for this health decision support tool to be publicly available.