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Country/Region: México

PE Guidelines
Economic Assessment Study Guideline for Updating The National Formulary in Mexico (2015)

PE Guidelines Source:
General Health Council
http://www.csg.gob.mx/descargas/pdfs/2015/GCEEE_2015.pdf

PDF in Spanish

Additional Information:
In order to regulate all the processes for updating the National Formulary there is the Internal Regulation of the National Formulary of Health Sector Institutional Commission. Its principal aim is to contribute and improve the quality, safety and efficiency of health care that grant public institutions of the National Health System.

Internal Regulation of the National Formulary of Health Sector Institutional Commission Source:
http://www.csg.gob.mx/contenidos/CB2013/normatividad.html

Last Webpage Update: Tuesday, May 17, 2016

PE Guidelines Key Features:

Key Features:  
Title and year of the documentEconomic Assessment Study Guideline for Updating The National Formulary in Mexico (2015)  
Affiliation of authorsGeneral Health Council. CANIFARMA, AMID, AMIIF, Pharmaceutical Industry, and Academics also contributed  
Purpose of the documentThe aim of this guideline is to lead the entire processes and criteria for preparation, presentation, analysis, evaluation, opinion and dissemination of proposals for updating the National Formulary and to provide an overview of the principles and methods of health technology assessment.  
Standard reporting format includedYes 
DisclosureYes 
Target audience of funding/ author's interestsDecision Makers, Researchers, Pharmaceutical Industry and Public Health Sector.  
PerspectivePublic Health Institutions  
IndicationCOFEPRIS approved indications 
Target populationThe patient population to be treated with the health technology under study. Age, gender, health status, relevant comorbidity and prognosis should be stated.  
Subgroup analysisYes 
Choice of comparatorCompare options must be alternatives that have the same indication at the National Formulary and Clinical Practice Guidelines.  
Time horizonIt depends on the natural history of the disease in order to cover all relevant costs and health effects.  
Assumptions requiredYes 
Preferred analytical techniqueCost-effectiveness, Cost-utility, Cost-benefit and Cost minimization  
Costs to be includedOnly direct costs  
Source of costsPublished Cost Lists of Public Health Institutions  
ModelingModeling should be applied if the available data are insufficient to allow a full assessment of the cost-effectiveness of an intervention. Models should be based as much as possible on data from meta-analysis or clinical studies.  
Systematic review of evidencesYes, if systematic reviews are available with existing clinical and economic analises of the comparator and in case of being available for the study drug, the search strategy should be transparent and reproducible. 
Preference for effectiveness over efficacyYes 
Preferred outcome measureIncremental Cost-Effectiveness Ratio (ICER)  
Preferred method to derive utilityNo preference for any 
Equity issues statedYes  
Discounting costs5%  
Discounting outcomes5%  
Sensitivity analysis-parameters and rangeParameters to consider include those with the greatest level of uncertainty, and those with the greatest influence on model outcomes.  
Sensitivity analysis-methodsSensitivity analysis should include probabilistic and deterministic methods.  
Presenting resultsThe results should be presented detailing the costs and clinical outcomes of each alternative. The budget impact results should be disaggregated by public health institution. 
Incremental analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)Yes 
Portability of results (Generalizability)Yes, the origin of the data used and the hypotheses adopted should be clearly specified.  
Financial impact analysisYes. Mandatory for orphan drugs.  
Mandatory or recommended or voluntaryMandatory for health technologies submission to National Formulary.  

Acknowledgement: Luz Helena Saavedra-Valdemar & Rosa María Galindo-Suárez, General Health Council, Ministry of Health, Mexico City, Mexico

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