Country/Region: Egypt
PE Guidelines

Guidelines for Reporting Pharmacoeconomic Evaluations (8/28/2013)

PE Guidelines Source:

Egyptian Ministry of Health, Egyptian Drug Authority

Additional Information:

lsisi G, Kaló Z, Eldessouki R, et al. Recommendations for Reporting Pharmacoeconomic Evaluations in Egypt.
Value in Health Regional Issues 2013; 2: 319-327.

Information up to date as of Tuesday, January 21, 2020

PE Guidelines Key Features:

Key Features:  
Title and year of the document
Guidelines for reporting pharmacoeconomic evaluations in Egypt (2013) 
Affiliation of authors
Pharmacoeconomic Unit, Central Administration for Pharmaceutical Affairs 
Purpose of the document
Provide a scientific guidance to conduct and report a PE study 
Standard reporting format included
Target audience of funding/ author's interests
Public and private payers, healthcare industries and clinicians 
It should be relevant to the research question and adapted to benefits gained by the health care system. 
It should be used in the approved Indications.  
Target population
Both those who are insured and uninsured by the Egyptian health care system. 
Subgroup analysis
Only for those whom clinical and cost effectiveness may be expected to differ from that of the overall population. 
Choice of comparator
Comparators should be policy relevant. The widely used and reimbursed health care technology for a given patient group is the preferred option. 
Time horizon
It should be ensured that the chosen outcome and the resource consumption of the treatment alternatives are observable in this period.  
Assumptions required
Preferred analytical technique
Any of CMA, CEA and CUA considered.  
Costs to be included
Direct medical costs as well as additional costs, savings or other benefits when data are available. 
Source of costs
Primary data collection; if unavailable, secondary data sources can be used such as local administration, accounting data patient chart review. Official sources of unit cost data for products (e.g. tender lists) are preferable.  
Modeling options include decision trees and Markov models. The model should be described in detail and should correspond to real practice of patient management. 
Systematic review of evidences
Preference for effectiveness over efficacy
Preferred outcome measure
Primary outcome measures are the first choice. In CEA, where intermediate marker is chosen, must have a validated, well established link with an important hard-end point. In CUA, outcomes are measured in QALY gained.  
Preferred method to derive utility
The direct use of EQ-5D, SF-6D or similar generic measures is recommended. 
Equity issues stated
All lives, life years, or QALYs should be valued equally, regardless of age, gender, or socioeconomic status of individuals in the population. 
Discounting costs
A discount rate of 3.5 % per year should be used for costs and outcomes. 
Discounting outcomes
A discount rate of 3.5 % per year should be used for costs and outcomes. 
Sensitivity analysis-parameters and range
Critical component(s) in the calculation should be varied through a relevant range or from worst case to best case.  
Sensitivity analysis-methods
DSA should be required, whilst PSA remains optional.  
Presenting results
Total costs and health outcomes must be reported separately, and the aggregated result be explained.The probability that the intervention is cost-effective at a range of threshold values should be reported and displayed graphically. 
Incremental analysis
ICER has to be calculated.  
Total costs vs effectiveness (cost/effectiveness ratio)
Portability of results (Generalizability)
The generalizability and extent to which the clinical efficacy data and the economic data are representative should be identified and discussed. 
Financial impact analysis
Not required but recommended when data is available 
Mandatory or recommended or voluntary
Recommended in the mean time but expected to be mandatory in few years 

Acknowledgement: Gihan Elsisi MSc, PhD(c), Head of Pharmacoeconomic Unit, Central Administration for Pharmaceutical Affairs, MOHP; Randa Eldessouki MBBCH, MSc, MD, Director of Scientific Initiatives, ISPOR; Mahmoud Elmahdawy Pharm D, Manager of Hospital Pharmacy Administration, Central Administration for Pharmaceutical Affairs, MOHP

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