Guideline for the economic evaluation of medicines (CAPF / Spanish NHS Advisory Committee for Pharmaceutical Financing)
This guideline provides a structured approach to assess the economic value of medicines within Spain's National Health System. It defines key aspects that should be included in evaluations, such as study design, costs, health outcomes, and ethical considerations, helping ensure consistent and high-quality assessments.
At a glance
Use when
Evaluating new medicines for reimbursement in the Spanish NHS,Designing economic evaluations aligned with national standards,Assessing methodological quality of HTA submissions,Supporting policy development in pharmaceutical financing
Avoid when
Assessing non-pharmaceutical health technologies not covered by the reference case,Working outside the Spanish health system context where criteria may not apply
Inputs
Data on clinical effectiveness, safety, costs, patient-reported outcomes, and organizational impact of medicines
Outputs
Structured economic evaluation reports aligned with a defined reference case and quality checklist
How it works
The guideline outlines 17 methodological dimensions for economic evaluations of medicines, establishes a reference case framework, and includes a checklist for assessing methodological quality and reporting transparency. It was commissioned by Spain's Ministry of Health to support reform in health technology assessment processes and promote standardized, evidence-based decision-making across stakeholders.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Organisational aspects
- Categories
- Cost-effectiveness ModellingCosting & Resource UsePricing/PayerReporting Standards & Best Practice
- Assumptions
- The guideline assumes availability of reliable clinical and cost data, willingness to adopt standardized methods, and alignment with national health policy objectives
- Strengths
- Comprehensive coverage of 17 methodological dimensions, promotes transparency and consistency, supports policy reform, applicable to multiple stakeholder groups
- Limitations
- May require adaptation for non-pharmaceutical technologies, implementation depends on institutional uptake and regulatory integration
- Also known as
- Guideline for the economic evaluation of medicines, CAPF guideline, Spanish NHS CAPF guideline
Questions this answers
- › What are the key methodological requirements for conducting an economic evaluation of medicines in the Spanish NHS context?
- › How should a reference case for economic evaluation of medicines be structured?
- › What criteria should be used to assess the methodological quality and reporting of economic evaluations?
- › Which dimensions (e.g., clinical, economic, ethical) must be addressed in medicine evaluations?
- › How can stakeholders ensure consistency and validity in health economic assessments?
- › What role does this guideline play in shaping health technology assessment reforms in Spain?
References & sources
Similar by meaning
- Spanish recommendations on economic evaluation of health technologies (López-Bastida guideline)
- CAPF reform of economic evaluation of medicines in Spain (three-phase reform proposals)
- Revised methods guide for economic evaluation studies of health technologies in Portugal
- Dutch Guideline for Economic Evaluations in Healthcare
- AIFA Guidelines for the economic evaluation of health technologies (P&R dossier, Chapter 9)
Beta record. Based on the original catalogue summary; primary-source enrichment pending.