Pharmacoeconomic Guidelines: Brazil

Country/Region: Brazil
PE Guidelines
Methodological Guidelines: Economic Evaluation of Health Technologies (2014)
PDF in Portuguese
PE Guidelines Source:
Brazil Ministry of Health
http://www.saude.gov.br

Information current as of Monday, January 15, 2018

Key Features

Type of Guidelines PE Guidelines
Title and year of the document Methodological Guidelines: Economic Evaluation of Health Technologies (2014)
Affiliation of authors Universities, government.
Purpose of the document Contribute to the standardization of the local studies in order to improve transparency, review and reproduction of them.
Standard reporting format included Yes
Disclosure Yes
Target audience of funding/ author's interests Either those who conduct HE evaluation or those who evaluate such studies (decision makers)
Perspective Preferably the one of the public payer. Societal perspective also possible
Indication Approved indications
Target population Clearly specified
Subgroup analysis When either there is a group of similar alternatives or a variability in clinical practice among a subgroup of patients
Choice of comparator Most prevalent treatment in the public system, most used treatment
Time horizon It must have as a basis the natural history of the disease in order to capture all relevant costs and consequences
Assumptions required Yes
Preferred analytical technique Cost-consequence Analysis, CMA, CEA, CUA, CBA
Costs to be included It depends on the perspective of the study: direct costs with/without indirect costs.
Source of costs Government databases and other public databases when necessary
Modeling Yes
Systematic review of evidences Yes
Preference for effectiveness over efficacy Yes. Efficacy has to be converted into effectiveness by means of appropriate methods. Details must be provided.
Preferred outcome measure Effectiveness
Preferred method to derive utility standard gamble, time trade-off, personal trade-off or visual analogue scale.
Equity issues stated Yes
Discounting costs Base case: 5% (0%-10% in S.A.)
Discounting outcomes Base case: 5% (0%-10% in S.A.)
Sensitivity analysis-parameters and range For all uncertain parameters, a plausible range must be defined for each parameter. A 2nd order Monte Carlo simulation to be used when applicable.
Sensitivity analysis-methods One-way, multi-way, probabilistic analysis
Presenting results The report has to be clear, detailed and transparent. A 3-page executive summary must be written in a context accessible to a non-technical reader.
Incremental analysis Yes
Total costs vs effectiveness (cost/effectiveness ratio) Yes
Portability of results (Generalizability) Yes; details must be provided.
Financial impact analysis Yes
Mandatory or recommended or voluntary Recommended

Acknowledgement:

Mario Giorgio, Managing Director, Asigma, São Paulo, Brazil contributed to the key features form. 
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