Country/Region: Italy
Published PE Recommendations

Linea guida per la compilazione del capitolo 9 del Dossier a supporto della domanda di rimborsabilità e prezzo (May 2020)
PDF in English

Published PE Recommendations Source:

Italian Medicines Agency

Additional Information:

Standard reporting template

Information up to date as of Tuesday, August 11, 2020

Published PE Recommendations Key Features:

Key Features:  
Title and year of the document
Guidance to applicants for the submission of pharmacoeconomic analysis within the Pricing and Reimbursement Dossier  
Affiliation of authors
Italian Medicines Agency  
Purpose of the document
Providing guidance to applicants for conducting and reporting economic evaluations and budget impact analyses in order to improve their quality, consistency and transparency  
Standard reporting format included
Yes, template available here https://www.aifa.gov.it/web/guest/linea-guida-capitolo-9 
Disclosure
The disclosure of funding is not explicitly requested, however it is a requirement for formal reimbursement submissions.  
Target audience of funding/ author's interests
Pharmaceutical companies submitting reimbursement applications to the Italian Medicines Agency  
Perspective
Italian National Health Service (base case). A supplementary analysis can be provided using a broader societal perspective.  
Indication
The authorised indication(s) of the product that is requested for reimbursement (ie. either the full licensed indication or a sub-group of the population covered by the marketing authorisation)  
Target population
Population of the reimbursement application  
Subgroup analysis
Heterogeneity issues shoud be explored in sensitivity analyses, when relevant.  
Choice of comparator
The comparator(s) should be the Italian Standard of Care, whenever possible, or the best treatment strategies reccomended by national or international guidelines. The exclusion of any relevant alternatives should be clearly stated and justified.  
Time horizon
5 years, 10 years, and lifetime  
Assumptions required
All the assumptions required should be clearly described and justified  
Preferred analytical technique
Cost-effectiveness and/or cost-utility analyses. Cost-minimisation analysis only for limited cases.  
Costs to be included
Health care costs. Indirect costs and non-health care costs could be considered in a supplementary analysis from the societal perspective.  
Source of costs
National costs relevant to the NHS (ie. National Tariffs or costing studies in the Italian context). Medicine costs should be based on ex-factory prices, net of mandatory reductions (Determinazioni AIFA 3 luglio 2006, Determinazione AIFA 27 settembre 2006).  
Modeling
Yes. It is recommended that electronic models are submitted especially for pharmaceuticals which are candidate for the innovativeness status. Internal and external validity of the model should be checked and reported.  
Systematic review of evidences
Not required  
Preference for effectiveness over efficacy
Not stated  
Preferred outcome measure
Not stated  
Preferred method to derive utility
Methods to derive utilities should be clearly described. Whenever possible, Italian values should be used.  
Equity issues stated
Not stated 
Discounting costs
Annual discount rate of 3%, and between 0% and 5% in sensitivity analyses  
Discounting outcomes
Annual discount rate of 3%, and between 0% and 5% in sensitivity analyses  
Sensitivity analysis-parameters and range
All uncertain parameters should be included. Ranges of variation and distributions of the parameters should be clearly reported.  
Sensitivity analysis-methods
Univariate deterministic sensitivity analyses and probabilistic sensitivity analysis for parameter uncertainty, supported by graphical representation. Scenario analyses are also recommended in some cases.  
Presenting results
Total and incremental cost, total and incremental effectiveness and ICER. Moreover, total costs should be also reported for each type of resources and for each health states in the model.  
Incremental analysis
Yes 
Total costs vs effectiveness (cost/effectiveness ratio)
Yes 
Portability of results (Generalizability)
The results should reflect the Italian health care setting.  
Financial impact analysis
Yes  
Mandatory or recommended or voluntary
Recommended  

Acknowledgement: Pierluigi Russo, Angelica Carletto, Annalisa Sammarco, and Matteo Zanuzzi, Italian Medicines Agency

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