Standardizing economic evaluation in Spain's pharmaceutical pricing and reimbursement system: specification, interpretation and integration.

INTRODUCTION

Economic evaluation (EE) is a key input for pharmaceutical pricing and reimbursement (P&R), yet countries differ in how EE is specified, interpreted and integrated into decisions. Spain is a timely case: despite long-standing legal recognition of efficiency, EE has historically been weakly operationalized and difficult to trace in P&R.

AREAS COVERED: This narrative review analyses Spain's reform trajectory through the lenses of specification, interpretation and integration, focusing on the work of the Advisory Committee for Pharmaceutical Financing (CAPF) (2019-2024). Evidence was identified through searches in PubMed, Scopus, Web of Science and Google Scholar (2000-2025), complemented by Spanish and EU legislative and policy documents. The review synthesizes CAPF recommendations to reorganize the evaluation pathway, including structured model linking clinical assessment, EE and budget impact analysis, and publication of national guideline and reference case. It also examines how these initiatives interact with draft national reforms and the EU HTA Regulation, highlighting a hybrid transitional context (late 2025) in which Joint Clinical Assessments are progressively incorporated while national procedural reform remains incomplete.

EXPERT OPINION: Spain illustrates how EE standardization can strengthen deliberative, multi-criteria P&R by improving transparency and coherence, although impact depends on regulatory enactment, capacity and implementation.