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: