Challenges and reforms in Spain’s health technology assessment system: analysis of criteria influencing medicines’ reimbursement decisions between 2019 and 2022 in Spain

Pilar Pinilla-Dominguez () and Jaime Pinilla-Dominguez
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Pilar Pinilla-Dominguez: University of Las Palmas de Gran Canaria (ULPGC)
Jaime Pinilla-Dominguez: University of Las Palmas de Gran Canaria (ULPGC)

The European Journal of Health Economics, 2025, vol. 26, issue 9, No 4, 1569-1579

Abstract: Abstract Objective To analyse the criteria influencing medicines’ reimbursement decisions in the Spanish National Health Service and assess the extent to which these decisions have been supported by health technology assessment (HTA), considering the ongoing HTA reform. Materials and methods The sample includes all new medicines and new indications undergoing reimbursement between May 2019 and December 2022 in Spain. Criteria influencing the decision were derived from the Interministerial Pricing Committee for Medicines’ reports. These were matched with the HTA reports obtained from the Spanish Medicines Agency’s website. Spanish decisions are compared to those in France and England. The analyses include descriptive analysis, association statistical tests, sentiment text analysis, keyword extraction, decision analysis, and clustering. Results Out of 477 therapeutic indications, 253 could be matched to a HTA report. Positive recommendations (n = 110) were statistically significantly associated with severity and therapeutic value (including clinical and cost effectiveness) criteria, whereas negative recommendations (n = 143) were mostly associated with criteria based on budget impact and availability of a cheaper alternative option (p

Keywords: Pricing and reimbursement; Health technology assessment; Pharmaceutical policy (search for similar items in EconPapers)
Date: 2025
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DOI: 10.1007/s10198-025-01790-7

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