OBJECTIVES: In June 2023, the Spanish National Court (Audiencia Nacional) annulled the “2020 plan for consolidating therapeutic positioning reports (IPTs)”, which included REvalMED’s pilot program for the integration of economic evaluations (EEs) into the IPTs. This study aimed to assess the progress made during the extent of the pilot program in regards to the integration of EEs into the IPTs in Spain.

METHODS: REvalMED meeting minutes published between October 2020 and May 2023 were screened to identify products entering the pilot program and their corresponding IPTs were retrieved. Data on time for assessment (time between entering the pilot program and IPT publication), therapeutic area and methodology used in the EEs of IPTs were collected.

RESULTS: Thirty products entered the pilot program, most of them in oncology (n=14). The time to publish an IPT with an associated EE (16.5 months) was longer than before the pilot program implementation (6.7 months). Within the 17 IPTs published at the time of search, 5 EEs were cost-utility, 4 were cost-effectiveness and 4 were cost-minimization analyses. Cost-effectiveness was not possible to assess in 4 cases. Among the 10 EEs developed de-novo by REvalMED, all included direct medical costs only. Of these, four (40%) included drug costs only, with no rationale for exclusion of other direct medical costs.

CONCLUSIONS: Although the REvalMED pilot program was annulled and the time needed for assessment doubled, it succeeded in setting a precedent for the inclusion of EEs into IPTs in Spain, demonstrating a willingness to incorporate economic modelling into a process that has been historically clinically driven. Any future endeavours will require data generation activities at the national level to ensure the EEs inputs are representative of the Spanish landscape. Early payer engagement will be crucial to validate national EEs models before submission to the authorities.