Pharmacoeconomic Guidelines: Iran

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


Information current as of Thursday, April 12, 2018

Key Features

Type of Guidelines Submission Guidelines
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
Disclosure It should be declared
Target audience of funding/ author's interests Without any conflict of interest with company
Perspective Society, Payer
Indication 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
Modeling 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 Yes
Discounting outcomes Yes
Sensitivity analysis-parameters and range Deterministic
Sensitivity analysis-methods One way, Tornado
Presenting results Provide results based on ICER
Incremental analysis Yes
Total costs vs effectiveness (cost/effectiveness ratio) Yes
Portability of results (Generalizability) Yes
Financial impact analysis Yes
Mandatory or recommended or voluntary Mandatory

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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