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

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  • Pilar Pinilla-Dominguez

    (University of Las Palmas de Gran Canaria (ULPGC)
    National Institute for Health and Care Excellence)

  • Jaime Pinilla-Dominguez

    (University of Las Palmas de Gran Canaria (ULPGC))

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

Suggested Citation

  • Pilar Pinilla-Dominguez & Jaime Pinilla-Dominguez, 2025. "Challenges and reforms in Spain’s health technology assessment system: analysis of criteria influencing medicines’ reimbursement decisions between 2019 and 2022 in Spain," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 26(9), pages 1569-1579, December.
    • Handle: RePEc:spr:eujhec:v:26:y:2025:i:9:d:10.1007_s10198-025-01790-7
    DOI: 10.1007/s10198-025-01790-7
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