Country/Region: Iran
Submission Guidelines

Criteria for developing an economic evaluation file - 2017 to 2019
PDF in Farsi

Submission Guidelines Source:

Iran FDA, Medicine selecting committee secretriate

Additional Information:
Information up to date as of Thursday, April 12, 2018

Submission Guidelines Key Features:

Key Features:  
Title and year of the document
Criteria for developing an economic evaluation file - 2017 to 2019  
Affiliation of authors
Dr. Cheraghali: Head of economic committee. Dr.Nikfar: Head of IDL committee. Dr. Dinarvand: previous Head of IFDA  
Purpose of the document
Drug costs and resource constraints  
Standard reporting format included
Two parts: Economic evaluation, budget impact  
It should be declared  
Target audience of funding/ author's interests
Without any conflict of interest with company  
Society, Payer  
Indication approved by the Clinical Committee  
Target population
Age, Sex, Geographic Distribution of Disease in the Country  
Subgroup analysis
If there is evidence of better results in subgroups, analysis in subgroup should be done.  
Choice of comparator
Comparator approved by the Clinical Committee  
Time horizon
Based on Nature of the disease and treatment method and results  
Assumptions required
According to feasibility of study and availability of data  
Preferred analytical technique
Cost utility analysis (CUA), Cost Effectiveness analysis (CEA), Cost Minimization analysis (CMA)  
Costs to be included
Direct Costs, Indirect Costs, Intangible Costs 
Source of costs
Weighted average of the private and public sector  
Markov model, Treeage, Monte carlo  
Systematic review of evidences
RCT, Meta analysis  
Preference for effectiveness over efficacy
Prefered outcome measure  
Preferred outcome measure
Life Year or QALY  
Preferred method to derive utility
To complete generic form of quality of life questions  
Equity issues stated
Not yet  
Discounting costs
Discounting outcomes
Sensitivity analysis-parameters and range
Sensitivity analysis-methods
One way, Tornado 
Presenting results
Provide results based on ICER  
Incremental analysis
Total costs vs effectiveness (cost/effectiveness ratio)
Portability of results (Generalizability)
Financial impact analysis
Mandatory or recommended or voluntary

Acknowledgement: Shekoufeh Nikfar, PharmD, MPH, PhD, Associate Professor, Tehran University of Medical Sciences, Tehran, Iran contributed to the key feature form.

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