OBJECTIVES: Previous health economic evaluation guidelines have been developed in Spain, but in 2023 the Ministry of Health's Pharmacy General Directorate commissioned a guidance document primarily intended for medicines evaluation. The objective of this methodological note is to present the official English translation of the commissioned guideline for health economic evaluation of medicines proposed by the Advisory Committee for the Financing of Pharmaceutical Benefits of the National Health System (“Comité Asesor de la Prestación Farmacéutica del SNS” [CAPF]).

METHODS: The development process involved a review of previous Spanish guidelines on the subject, as well as selected international guidelines primarily from Australia, Canada, the United States, England and Wales, France, and Portugal, with a focus on the latter two. Additionally, the CHEERS 2022 statement and the EUnetHTA Guideline were considered

RESULTS: This guideline includes 17 dimensions that an economic evaluation of medicines must encompass, designing a base case, and defining a checklist for evaluating the methodological quality and reporting. This guideline should serve as a foundational document for reforming the health technologies evaluation processes of the Ministry of Health. The guideline can also assist researchers, public health professionals, health technology companies and decision makers in assessing the validity of findings and conclusions from health economic evaluations.

CONCLUSIONS: The proposed health economic guideline represents an essential tool for health services seeking to optimize the allocation of resources, promoting interventions with the best cost-effectiveness ratio, improving the quality of care, and ensuring the long-term sustainability of the system.