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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.

Last Webpage Update: Monday, January 15, 2018

PE Guidelines Key Features:

Key Features:  
Title and year of the documentGuidelines for reporting pharmacoeconomic evaluations in Egypt (2013) 
Affiliation of authorsPharmacoeconomic Unit, Central Administration for Pharmaceutical Affairs 
Purpose of the documentProvide a scientific guidance to conduct and report a PE study 
Standard reporting format includedyes 
Target audience of funding/ author's interests Public and private payers, healthcare industries and clinicians 
PerspectiveIt should be relevant to the research question and adapted to benefits gained by the health care system. 
IndicationIt should be used in the approved Indications.  
Target populationBoth those who are insured and uninsured by the Egyptian health care system. 
Subgroup analysisOnly for those whom clinical and cost effectiveness may be expected to differ from that of the overall population. 
Choice of comparatorComparators should be policy relevant. The widely used and reimbursed health care technology for a given patient group is the preferred option. 
Time horizonIt should be ensured that the chosen outcome and the resource consumption of the treatment alternatives are observable in this period.  
Assumptions requiredyes 
Preferred analytical techniqueAny of CMA, CEA and CUA considered.  
Costs to be includedDirect medical costs as well as additional costs, savings or other benefits when data are available. 
Source of costsPrimary 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.  
ModelingModeling 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 evidencesyes 
Preference for effectiveness over efficacyyes 
Preferred outcome measurePrimary 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 utilityThe direct use of EQ-5D, SF-6D or similar generic measures is recommended. 
Equity issues statedAll lives, life years, or QALYs should be valued equally, regardless of age, gender, or socioeconomic status of individuals in the population. 
Discounting costsA discount rate of 3.5 % per year should be used for costs and outcomes. 
Discounting outcomesA discount rate of 3.5 % per year should be used for costs and outcomes. 
Sensitivity analysis-parameters and rangeCritical component(s) in the calculation should be varied through a relevant range or from worst case to best case.  
Sensitivity analysis-methodsDSA should be required, whilst PSA remains optional.  
Presenting resultsTotal 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)yes 
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 analysisNot required but recommended when data is available 
Mandatory or recommended or voluntaryRecommended 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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