Italian Group of Pharmacoeconomic Studies (GISP) guidelines for economic evaluations in Italy
These are the first official Italian guidelines for conducting economic evaluations in healthcare, developed by a group of pharmacoeconomics experts. They helped shape how cost-effectiveness studies are done in Italy before official agency guidance existed.
At a glance
Use when
Conducting early pharmacoeconomic evaluations in Italy; understanding historical development of HTA methods in Italy; informing studies prior to AIFA guidance adoption
Avoid when
Complying with current AIFA submission requirements; when up-to-date national HTA guidance is available and mandatory
Inputs
Data on healthcare costs, clinical outcomes, resource use, and patient-level inputs relevant to pharmacoeconomic analysis
Outputs
Structured economic evaluation reports with cost-effectiveness, cost-utility, or cost-benefit results applicable to Italian decision-making
How it works
Published in 2001 by the Italian Group of Pharmacoeconomic Studies (GISP) in Drug Inf J (Ther Innov Regul Sci), these guidelines provide methodological recommendations for pharmacoeconomic evaluations in Italy. They cover study design, cost measurement, outcome assessment, and analysis methods, serving as a foundational reference prior to AIFA's formal HTA guidance.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Organisational aspects
- Assumptions
- The healthcare system is the primary perspective; comparators should be relevant to Italian practice; long-term outcomes may be extrapolated from short-term data
- Strengths
- First nationally relevant guidance in Italy; expert-driven development; methodological rigor; paved the way for institutional HTA frameworks
- Limitations
- Predate formal HTA agency oversight; may lack alignment with current AIFA requirements; limited consideration of patient-reported outcomes or broader social aspects
- Also known as
- GISP guidelines
Questions this answers
- › What methods are appropriate for economic evaluations in the Italian healthcare context?
- › How should costs and outcomes be measured and valued in pharmacoeconomic studies?
- › What study designs are recommended for comparing healthcare interventions?
- › How should uncertainty be addressed in economic models?
- › What reporting standards should be followed for economic evaluations in Italy?
- › How do these guidelines inform later AIFA recommendations?
References & sources
Similar by meaning
- AIFA Guidelines for the economic evaluation of health technologies (P&R dossier, Chapter 9)
- Hungarian Methodological Guidelines for Economic Evaluation of Healthcare Interventions
- iDSI Reference Case for Economic Evaluation
- Spanish recommendations on economic evaluation of health technologies (López-Bastida guideline)
- Guideline for the economic evaluation of medicines (CAPF / Spanish NHS Advisory Committee for Pharmaceutical Financing)
Beta record. Based on the original catalogue summary; primary-source enrichment pending.