Pharmacoeconomic Guidelines: Portugal

Country/Region: Portugal
PE Guidelines
Guidelines for Economic Drug Evaluation Studies (1998)
PDF in EnglishPDF in Portuguese
PE Guidelines Source:
INFARMED – National Authority of Medicines and Health Products, IP

Information current as of Thursday, April 28, 2016

Key Features

Type of Guidelines PE Guidelines
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 Yes
Disclosure Yes
Target audience of funding/ author's interests Researchers, policy-makers, health authorities, marketing authorisation holders
Perspective Societal, should be broken down into other relevant points of view namely third payer
Indication 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 Yes
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.
Modeling Yes, data should reflect the situation in the country
Systematic review of evidences Yes
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: consider 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 Required
Total costs vs effectiveness (cost/effectiveness ratio) Required
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 Mandatory


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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