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 document
Economic Assessment Study Guideline for Updating The National Formulary in Mexico (2015)  
Affiliation of authors
General Health Council. CANIFARMA, AMID, AMIIF, Pharmaceutical Industry, and Academics also contributed  
Purpose of the document
The 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 included
Yes 
Disclosure
Yes 
Target audience of funding/ author's interests
Decision Makers, Researchers, Pharmaceutical Industry and Public Health Sector.  
Perspective
Public Health Institutions  
Indication
COFEPRIS approved indications 
Target population
The patient population to be treated with the health technology under study. Age, gender, health status, relevant comorbidity and prognosis should be stated.  
Subgroup analysis
Yes 
Choice of comparator
Compare options must be alternatives that have the same indication at the National Formulary and Clinical Practice Guidelines.  
Time horizon
It depends on the natural history of the disease in order to cover all relevant costs and health effects.  
Assumptions required
Yes 
Preferred analytical technique
Cost-effectiveness, Cost-utility, Cost-benefit and Cost minimization  
Costs to be included
Only direct costs  
Source of costs
Published Cost Lists of Public Health Institutions  
Modeling
Modeling 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 evidences
Yes, 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 efficacy
Yes 
Preferred outcome measure
Incremental Cost-Effectiveness Ratio (ICER)  
Preferred method to derive utility
No preference for any 
Equity issues stated
Yes  
Discounting costs
5%  
Discounting outcomes
5%  
Sensitivity analysis-parameters and range
Parameters to consider include those with the greatest level of uncertainty, and those with the greatest influence on model outcomes.  
Sensitivity analysis-methods
Sensitivity analysis should include probabilistic and deterministic methods.  
Presenting results
The 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 analysis
Yes 
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 analysis
Yes. Mandatory for orphan drugs.  
Mandatory or recommended or voluntary
Mandatory 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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