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

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 < 0.05). The innovation criterion was not used to support any decision. Only 9.49% of reimbursement reports mentioned the HTA in the conclusions, and 21.74% of the HTAs included keywords aligned with the specific decision-making criteria.

Conclusion: The criteria used to justify the reimbursement decisions of medicines in Spain do not align with the information included in the HTA. This discrepancy highlights the need for the ongoing HTA reform to develop an appraisal framework that aligns with the HTA assessment in a transparent, rigorous, and inclusive manner.