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 document
Guidelines for Economic Evaluations in Italy: Recommendations from the Italian Group of Pharmacoeconomic Studies (Manuscript 2001) 
Affiliation of authors
Italian Group for Pharmacoeconomic Studies 
Purpose of the document
Pricing and reimbursement 
Standard reporting format included
Yes, includes Summary, Synthesis, and Detailed version of the EE 
Disclosure
Not specific, mentioned to list the authors and sponsor of the EE 
Target audience of funding/ author's interests
Pharmaceutical companies. Italian National Health Service. researchers 
Perspective
Societal, Italian National Health Service 
Indication
Yes 
Target population
Yes 
Subgroup analysis
Yes 
Choice of comparator
Most wide-spread treatment. Solid evidence for a scientifically-based comparison must be available. 
Time horizon
Not specific 
Assumptions required
Not stated 
Preferred analytical technique
CEA, CUA 
Costs to be included
Societal: both direct costs and indirect costs. Use human capital method for indirect costing. 
Source of costs
Use microcosting carried out through studies performed at health care structures 
Modeling
Yes, requires details 
Systematic review of evidences
Yes, check internal and external validity 
Preference for effectiveness over efficacy
Yes, studies must refer to the national context. 
Preferred outcome measure
Effectiveness by intention-to-treat principle, and expressed in natural units or QALY 
Preferred method to derive utility
Standard gamble, time trade-off 
Equity issues stated
Not stated 
Discounting costs
Base:3%; SA: 0%~8% 
Discounting outcomes
Base:3%; SA: 0%~8% 
Sensitivity analysis-parameters and range
Those parameters which have the most influence on the final results. Effectiveness use CI, range of cost decided by author. 
Sensitivity analysis-methods
Better showing simultaneous effect of the variations for the more important parameters 
Presenting results
Must be able to provide adequate response to three questions: Valid and acceptable? What information emerges? What can be applied to actual situations? 
Incremental analysis
Yes 
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 analysis
Yes, 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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