Pharmacoeconomic Guidelines: Portugal
Country/Region: Portugal

PE Guidelines
PE Guidelines Source:
INFARMED – National Authority of Medicines and Health Products, IP
http://www.infarmed.pt/
http://www.infarmed.pt/
Information current as of Thursday, April 28, 2016
Key Features
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 |
Acknowledgement: