AIFA Guidelines for the economic evaluation of health technologies (P&R dossier, Chapter 9)
These guidelines explain how to carry out economic evaluations for health technologies in Italy, particularly for pricing and reimbursement applications. They specify when to use cost-effectiveness or cost-minimization analyses, how long the analysis should cover, and which costs to include.
At a glance
Use when
Submitting a pricing and reimbursement dossier in Italy; conducting economic evaluations for new drugs, especially orphan drugs, new active substances, or new indications
Avoid when
Conducting international HTA submissions outside Italy; evaluating non-pharmaceutical technologies where AIFA guidance may not apply
Inputs
Clinical effectiveness data, cost data, comparator information, disease epidemiology, healthcare resource use, utility values (if applicable)
Outputs
Economic evaluation report compliant with AIFA requirements, including cost-effectiveness or cost-minimization results
How it works
Developed by Agenzia Italiana del Farmaco (AIFA), these guidelines provide methodological standards for economic evaluations submitted in price-and-reimbursement (P&R) dossiers. They define requirements for choosing between cost-effectiveness analysis (CEA) and cost-minimization analysis (CMA), set recommendations on time horizons, and detail cost components to be included based on technology type (e.g., orphan drugs, new active substances, new indications).
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Organisational aspects
- Assumptions
- The technology under evaluation has sufficient clinical evidence to support economic modeling; comparators are appropriately selected and reflect current practice in Italy
- Strengths
- Provides clear, nationally standardized criteria for economic evaluations in Italy; supports transparency and consistency in reimbursement decisions; tailored to different types of health technologies
- Limitations
- Limited flexibility for innovative or complex technologies not fitting standard categories; may not fully account for broader social or patient-reported outcomes
- Also known as
- AIFA P&R Dossier Guidelines Chapter 9, AIFA Economic Evaluation Guidelines 2020
Questions this answers
- › When is a cost-effectiveness analysis required versus a cost-minimization analysis?
- › What time horizon should be used in economic models?
- › Which cost categories must be included in an economic evaluation for reimbursement?
- › How should new active substances be evaluated economically?
- › Are there specific rules for orphan drugs in economic evaluations?
- › What are the requirements for submitting economic evidence in Italian P&R dossiers?
References & sources
- websiteaifa.gov.it ↗
Similar by meaning
- Italian Group of Pharmacoeconomic Studies (GISP) guidelines for economic evaluations in Italy
- Guidelines for the Economic Evaluation of Health Technologies in Ireland (HIQA)
- Revised methods guide for economic evaluation studies of health technologies in Portugal
- Spanish recommendations on economic evaluation of health technologies (López-Bastida guideline)
- Guidelines for the Economic Evaluation of Health Technologies: Canada — 4th Edition
Beta record. Based on the original catalogue summary; primary-source enrichment pending.