OBJECTIVES: To assess the quality of economic evaluations (EE) and budget impact analyses (BIA) submitted by pharmaceutical companies to the Catalan Health Service (CatSalut) within the Medicines Harmonization framework.

METHODS: A revision of the EE and BIA received between December 2017 and May 2018 was performed based on the methodology guideline for economic evaluations and analyses (GAEIP) previously developed by CatSalut. The analysis was done through an adaptation of the validated checklist published in the guideline, which measures the inclusion or exclusion of 42 items for EE and 32 items for BIA. All the responses were aggregated in an anonymized dataset in order to calculate the average inclusion rate in each evaluation and the mean of compliance of each criterion.

RESULTS: CatSalut received 6 EE and 18 BIA during the studied period, mainly concerning oncology, rheumatology and respiratory medicines. EE included 70.6% of the checklist items on average albeit BIA had a 55.3% average inclusion rate. The use of a “crosswalk index value of EQ-5D adapted to Spain” was incorporated in 33.3% of the EE, whereas “health outcomes and cost data from relevant sources” was identified in 66.7% of them. Regarding BIA, the items “proper identification of the target population” and “choice of adequate comparators” were included in 66.7% and 44.4% of the reviewed submissions, respectively.

CONCLUSIONS: Study results suggest that the methodological quality of BIA is not entirely consistent with the GAEIP standards, while EE usually show a higher item inclusion rate. The difference could be associated with the requirement to develop more complex methods from the latest, which might also explain the fewer amount of EE submitted. The rates of inclusion of certain items appear to indicate that the implementation of GAEIP is still in process and there is a need to improve the quality of economic evaluations.