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Pharmacoeconomic Guidelines Around The World

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:

Last Webpage Update: Thursday, April 28, 2016

PE Guidelines Key Features:

Key Features:  
Title and year of the documentGuidelines for Economic Drug Evaluation Studies (1998) 
Affiliation of authorsINFARMED / ISEG / Lisbon University Faculty of Medicine / ENSP, UNL / CHE, University of York 
Purpose of the documentTo establish pharmacoeconomic studies methodology and requirements to provid to decision makers in the scope of reimbursement economic assessment 
Standard reporting format includedYes 
Target audience of funding/ author's interestsResearchers, policy-makers, health authorities, marketing authorisation holders  
PerspectiveSocietal, should be broken down into other relevant points of view namely third payer 
IndicationTarget therapeutic indication 
Target populationCorresponding as closely as possible to potential users 
Subgroup analysisPossible. 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 comparatorThe most common treatment, less expensive and most efficacious 
Time horizonShould be adequate to include time during which costs and consequences attributed to treatment occur.  
Assumptions requiredYes 
Preferred analytical techniqueAny scientific recognised economic evaluation technque can be used such as CMA, CEA, CUA, CBA  
Costs to be includedAll 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 costsMarket 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. 
ModelingYes, data should reflect the situation in the country 
Systematic review of evidencesYes 
Preference for effectiveness over efficacyYes,whenever possible 
Preferred outcome measureDepend on the type of study. Should be clearly identified 
Preferred method to derive utilityCUA: 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 statedNot stated 
Discounting costs5%. A sensitive analysis should be made of this rate. 
Discounting outcomes5%. 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 rangeKey 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-methodsNot specific 
Presenting resultsIn a way to be easily accessible and comprehensible to the recipients of the study, examples given. 
Incremental analysisRequired 
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 analysisRecommended, if appropriate, in the context of public financing. 
Mandatory or recommended or voluntaryMandatory 

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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