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Pharmacoeconomic Guidelines Around The World

Country/Region: Italy

Published PE Recommendations
Guidelines for Economic Evaluations in Italy: Recommendations from the Italian Group of Pharmacoeconomic Studies (Manuscript 2001)
PDF in English

Published PE Recommendations Source:

Additional Information:

Last Webpage Update: Monday, June 20, 2016

Published PE Recommendations Key Features:

Key Features:  
Title and year of the documentGuidelines for Economic Evaluations in Italy: Recommendations from the Italian Group of Pharmacoeconomic Studies (Manuscript 2001) 
Affiliation of authorsItalian Group for Pharmacoeconomic Studies 
Purpose of the documentPricing and reimbursement 
Standard reporting format includedYes, includes Summary, Synthesis, and Detailed version of the EE 
DisclosureNot specific, mentioned to list the authors and sponsor of the EE 
Target audience of funding/ author's interestsPharmaceutical companies. Italian National Health Service. researchers 
PerspectiveSocietal, Italian National Health Service 
Target populationYes 
Subgroup analysisYes 
Choice of comparatorMost wide-spread treatment. Solid evidence for a scientifically-based comparison must be available. 
Time horizonNot specific 
Assumptions requiredNot stated 
Preferred analytical techniqueCEA, CUA 
Costs to be includedSocietal: both direct costs and indirect costs. Use human capital method for indirect costing. 
Source of costsUse microcosting carried out through studies performed at health care structures 
ModelingYes, requires details 
Systematic review of evidencesYes, check internal and external validity 
Preference for effectiveness over efficacyYes, studies must refer to the national context. 
Preferred outcome measureEffectiveness by intention-to-treat principle, and expressed in natural units or QALY 
Preferred method to derive utilityStandard gamble, time trade-off 
Equity issues statedNot stated 
Discounting costsBase:3%; SA: 0%~8% 
Discounting outcomesBase:3%; SA: 0%~8% 
Sensitivity analysis-parameters and rangeThose parameters which have the most influence on the final results. Effectiveness use CI, range of cost decided by author. 
Sensitivity analysis-methodsBetter showing simultaneous effect of the variations for the more important parameters 
Presenting resultsMust be able to provide adequate response to three questions: Valid and acceptable? What information emerges? What can be applied to actual situations? 
Incremental analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)Yes 
Portability of results (Generalizability)Studies must refer to the national context (treatment for comparison, medical practice, costs, institutional structure, epidemiological structure, and reference population) 
Financial impact analysisYes, first and second year of marketing 
Mandatory or recommended or voluntary 

Acknowledgement: Simona Montilla, PhD, MSc, Pharmaceutical Policy Officer, Agenzia Italiana del Farmaco (AIFA), Rome, Italy

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