OBJECTIVES: To describe the health technology assessment (HTA) of drugs authorized by the European Medicines Agency (EMA) in Spain and their potential relation to the drugs’ reimbursement status.

METHODS: A list of human medicines centrally authorized from 01/2018-12/2021 was retrieved from the EMA website. The date of the Therapeutic Positioning Report (“IPT” from Spanish initials) publication was extracted from the Spanish Agency of Medicines and Medical Devices (AEMPS) website. IQVIA’s HTA Accelerator database contains HTA publications from over forty countries and was used to extract detailed IPT data, when available, categorizing the evaluators remarks by type and as positive or negative. A product was considered reimbursed when included in the national reimbursement list as of 20^th June 2023 (Nomenclátor).

RESULTS: A total of 168 new medicines were authorized by the EMA during the study period, of which 125 (74.4%) had an IPT published in Spain by 20^th June 2023. The proportion of drugs with an IPT was similar for orphan and non-orphan drugs (75.4% vs. 73.8%), and higher in oncology (84.8%). One in five (20.9%) products without an IPT were reimbursed versus 82.4% of products with an IPT. A sample of 89 (71.2%) IPTs was available in IQVIA’s HTA Accelerator, of which 79.8% were from reimbursed products. On average, 1.9 positive and 2.1 negative aspects were mentioned in the IPTs of reimbursed products versus 1.4 and 2.4, respectively, on IPTs of non-reimbursed products. Increased risk of adverse events was the most stated negative aspect of the drug, present in 11.7% of the analyzed IPTs (and in 18.2% of non-reimbursed products). Superiority versus placebo in the primary endpoint was the most common positive aspect (in 28.8% of reimbursed products’ IPTs vs. 10.0% of those non-reimbursed).

CONCLUSIONS: Incorporating the evidence needs of evaluators in the study designs may support reimbursement decisions.