Reform of economic evaluation of medicines in Spain: proposals from the Advisory Committee for Pharmaceutical Financing.

Abstract

This paper describes the reforms recommended by the Advisory Committee on the Financing of Pharmaceuticals (CAPF) for the National Health System (NHS) of Spain from 2019 to 2024 for the drug pricing and reimbursement process, to integrate economic evaluations and improve efficiency and sustainability. The CAPF has proposed a three-phase reform of the economic evaluation (EE) and budget impact analysis (BIA) processes. The first phase involves the mandatory submission of EE and BIA by applicants for new drugs. The second phase involves the assessment of these submissions, coordinated by the Directorate-General for Pharmaceuticals. The third phase focuses on the application of these assessments to decision-making on drug positioning, pricing and financing. The CAPF's recommendations emphasise improved regulation, transparency and the development of methodological guidelines for economic evaluations. These proposals include a dynamic appraisal system and the creation of official NHS guidance on EE and BIA. The process is designed to ensure compliance with established criteria and to incorporate efficiency into decision-making. The initiatives of the CAPF aim to make progress towards the integration of efficiency in Spanish pharmaceutical policy seeking to improve the methodological quality and transparency of economic evaluations, ultimately contributing to more informed decision-making and sustainable healthcare practices.