Spain Publishes New Guidance for Economic Evaluation of Pharmaceutical Pricing and Access
This new guideline provides recommendations for setting criteria and procedures that govern drug pricing decisions and market entry or withdrawal of new pharmaceuticals, offering a framework for their subsequent re-evaluation. It will serve as a methodological instrument for economic drug assessments by the Directorate-General of the Basic Portfolio of National Health System and Pharmacy Services (DGCF).
In the face of rising healthcare costs and the introduction of ground-breaking yet costly medications, Spain's healthcare system is facing the challenge of integrating such innovations without compromising sustainability and accessibility of care. The economic evaluation guideline of the Comité Asesor para la Financiación de la Prestación Farmacéutica del Sistema Nacional de Salud (CAPF) is a strategic response to the situation, aiming to put in place a clear and methodical evidence-driven process for assessing the economic ramifications of new pharmaceuticals.
This process aims to strike a balance between clinical advantages and financial impact. Such an approach is vital to streamline the allocation of resources for pricing and reimbursement of drugs within the Spanish National Health System, while at the same time upholding healthcare equity and patient access to efficacious treatments in an era marked by medical advancements.
The guideline covers the essential components of economic evaluation, from setting objectives and defining the evaluative scope to the nuanced appraisal of health outcomes and associated costs. It highlights:
The public (NHS) perspective with the potential of including the societal perspective.
The identification of target population and subgroups.
The methodology to identify comparators and prioritise the most efficacious or cost-effective therapies.
A preference for cost-utility analysis (CUA) employing Quality-Adjusted Life Years (QALYs) while also accommodating cost-effectiveness analysis (CEA) and cost-minimisation analysis (CMA) under specified conditions.
A requirement for robust evidence to support efficacy/effectiveness and safety, such as randomised controlled trials (RCTs), systematic reviews or, when needed, supplementary evidence such as indirect comparisons or observational studies.
That QALYs for CUA and clinically pertinent outcomes for CEA are preferred with a preference for patient-focused results.
That the analysis will include and justify costs relevant to the evaluated drug within the NHS budget, delineating resource quantities, unit costs, and inflation adjustments. It will ensure medication prices include VAT and reflect actual costs for the NHS, accounting for price variability in sensitivity analyses.
Modelling techniques that are clearly delineated and congruent with established best practices as well as conceptually validated.
Incorporating robust guidance for economic evaluation into Spain's drug assessment protocols is a critical advancement for the national healthcare system. Systematic economic evaluations reflect a commitment to transparency, efficiency, and inclusivity in healthcare decision-making. This commitment is embodied in the new Health Technology Assessment (HTA) system, which is set to be introduced by the end of the year. This system will replace the Revalmed framework and will operate through a structured three-phase process: evaluation, positioning, and decision-making, with an initial focus on oncological and advanced therapy medicinal products.
Source:
Ministerio de Sanidad, Consumo y Bienestar Social. (2023). Guía de Evaluación Económica de Medicamentos. Retrieved from https://www.sanidad.gob.es/areas/farmacia/comitesAdscritos/prestacionFarmaceutica/docs/20240227_CAPF_Guia_EE_definitiva.pdf
Written by Jorge Ferrer
Decisive Dialogue 25th April 2024
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