OBJECTIVES: To assess the reimbursement status and time to reimbursement of drugs authorized by European Medicines Agency (EMA) in Spain.

METHODS: A list with human medicines authorized by EMA during the period January 2018 to June 2021 was retrieved from the EMA website. Mainly, medicine name, active substance, therapeutic area, application type, and decision date were collected. To assess the reimbursement status in Spain, agreements from the Spanish Interministerial Commission on Prices and Health Products (CIMP) published from January 2018 to November 2021 were gathered, reviewed and its information extracted in a data collection form. National code, medicine name, active substance, decision adopted, criteria stated for decision, special funding conditions, if applicable, were collected for this purpose. The number of medicines with positive reimbursement decision and percentages, as well as the time since EMA approval to positive reimbursement decision were estimated for the total sample and several subcategories.

RESULTS: A total of 162 new medicines were authorized by EMA in the study period. 129 of them (79.6%) had requested national code and only 56 (34.6%) had been reimbursed. Oncologic drugs had a higher proportion of positive reimbursement decisions, 41.0%, compared with non-oncologic drugs, 32.5%. Mean time to reimbursement for all the medicines reviewed was 18.5 months, being 16.2 months for oncologic drugs and 19.4 months for non-oncologic drugs. Mean time to reimbursement for new indications in oncologic drugs was higher than new active substances 20.2 months and lower in non-oncologic drugs 14.3 months. When given an initial negative reimbursement decision, it took a mean of 5.3 months to obtain a positive reimbursement decision.

CONCLUSIONS: Only 1 in 3 new medicines authorized by EMA from January 2018 to June 2021 has a positive reimbursement decision in Spain, with an 18.5-month gap since EMA authorization.