OBJECTIVES: The Spanish Agency for Medicines and Health Products (AEMPS) has issued national therapeutic positioning reports (TPRs) for new medicines since 2013. These are comparative efficacy and safety reports which specify the patient population that will benefit most from new medicines. These were introduced to make access decision-making more transparent and consistent across autonomous communities. In November 2020, Revalmed (Pharmaceutical Evaluation Network) was created to be responsible for a revised process to make TPR development faster and to include pharmacoeconomic evaluations. The first therapy (talazoparib) evaluated under this new process was within a pilot project in June 2021. This research compares the outcomes of therapies assessed in 2022 under this new Revalmed process with those not.

METHODS: Publicly-available TPR decisions were identified from www.aemps.gob.es and key information extracted (01-January-2022–24-June-2022)

RESULTS: 53 TPRs were identified. 28/53 (53%) were resolutions for funding, 18/53 (34%) were for no funding and 7/53 (13%) had no recommendation. 21/53 (40%) were considered under the new Revalmed process. 13/21 (62%) were resolutions for funding, 1/21 (5%) was for no funding, and 7/21 (33%) had no recommendation. By comparison, of the 32/53 (60%) therapies were not assessed under Revalmed, and only 15/32 (47%) were resolutions for funding and the rest were for no funding (17/32, 53%).

CONCLUSIONS: TPRs assessed under the new Revalmed process in 2022 have much more favourable funding outcomes than those that have not been assessed under this process. Further, the potentially increased speed of development of TPRs under this new process, combined with inclusion of pharmacoeconomic considerations, may make these TPRs much more impactful in the Spanish national and regional reimbursement process going forward. Nevertheless, further research is needed to clarify whether this reflects different types of therapies being considered under Revalmed or whether this new process may help support more favorable assessments.