Country/Region: Portugal
PE Guidelines

Guidelines for Economic Drug Evaluation Studies (1998)
PDF in English; PDF in Portuguese

PE Guidelines Source:

INFARMED – National Authority of Medicines and Health Products, IP

Additional Information:
Information up to date as of Thursday, April 28, 2016

PE Guidelines Key Features:

Key Features:  
Title and year of the document
Guidelines for Economic Drug Evaluation Studies (1998) 
Affiliation of authors
INFARMED / ISEG / Lisbon University Faculty of Medicine / ENSP, UNL / CHE, University of York 
Purpose of the document
To establish pharmacoeconomic studies methodology and requirements to provid to decision makers in the scope of reimbursement economic assessment 
Standard reporting format included
Target audience of funding/ author's interests
Researchers, policy-makers, health authorities, marketing authorisation holders  
Societal, should be broken down into other relevant points of view namely third payer 
Target therapeutic indication 
Target population
Corresponding as closely as possible to potential users 
Subgroup analysis
Possible. Usually, it will only be considered if defined in advance and if the number of subgroups post hoc can be managed as a generator of hypotheses  
Choice of comparator
The most common treatment, less expensive and most efficacious 
Time horizon
Should be adequate to include time during which costs and consequences attributed to treatment occur.  
Assumptions required
Preferred analytical technique
Any scientific recognised economic evaluation technque can be used such as CMA, CEA, CUA, CBA  
Costs to be included
All relevant resources used as a result of the adoption of each treatment alternative. All direct and indirect costs should be identified. Advisable to include intangible costs. 
Source of costs
Market prices (societal perspective). Alternatively, DRGs or convention tables as the apprproximate price of health care (shadow prices) or fixing standard cost. Cost tables should be created and validated. 
Yes, data should reflect the situation in the country 
Systematic review of evidences
Preference for effectiveness over efficacy
Yes,whenever possible 
Preferred outcome measure
Depend on the type of study. Should be clearly identified 
Preferred method to derive utility
CUA: value-based methods validated for Portugal and justified as appropriate for the study. CBA: contingent valuation method prefered. Human capital method should only be used in exceptional, duly justified cases. 
Equity issues stated
Not stated 
Discounting costs
5%. A sensitive analysis should be made of this rate. 
Discounting outcomes
5%. A sensitive analysis (SA) should be made of this rate. If not valued in monetary terms, the SA should include the zero rate. 
Sensitivity analysis-parameters and range
Key parameters with values that are subject to uncertainty. For values obtained by sampling: considere confidence intervals for each estimate; for others values, variation intervals or alternative values justified in detail on the basis of empirical evidence or logic. 
Sensitivity analysis-methods
Not specific 
Presenting results
In a way to be easily accessible and comprehensible to the recipients of the study, examples given. 
Incremental analysis
Total costs vs effectiveness (cost/effectiveness ratio)
Portability of results (Generalizability)
Yes, the origin of the data used and the hypotheses adopted should be clearly specified 
Financial impact analysis
Recommended, if appropriate, in the context of public financing. 
Mandatory or recommended or voluntary

Acknowledgement: Carlos Gouveia Pinto, PhD, President, Research Center on the Portuguese Economy (CISEP), Lisbon School of Economics & Management University of Lisbon, Lisbon, Portugal

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