Pharmacoeconomic Guidelines: Egypt
Country/Region: Egypt
PE Guidelines
Guidelines for Reporting Pharmacoeconomic Evaluations (8/28/2013)
http://www.eda.mohp.gov.eg/Files/402_Egyptian_Pharmacoeconomic_guidelines.pdf
PE Guidelines Source:
Egyptian Ministry of Health, Egyptian Drug Authority
http://www.eda.mohealth.gov.eg/Articles.aspx?id=165
http://www.eda.mohealth.gov.eg/Articles.aspx?id=165
Additional Information:
Isisi G, Kaló Z, Eldessouki R, et al. Recommendations for Reporting Pharmacoeconomic Evaluations in Egypt.
Value in Health Regional Issues 2013; 2: 319-327.
http://www.valuehealthregionalissues.com/article/S2212-1099(13)00077-0/pdf
Value in Health Regional Issues 2013; 2: 319-327.
http://www.valuehealthregionalissues.com/article/S2212-1099(13)00077-0/pdf
Information current as of Monday, June 13, 2022
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | PE Guidelines |
| 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 | yes |
| Disclosure | yes |
| Target audience of funding/ author's interests | Public and private payers, healthcare industries and clinicians |
| Perspective | It should be relevant to the research question and adapted to benefits gained by the health care system. |
| Indication | 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 | yes |
| 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 | 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 | yes |
| Preference for effectiveness over efficacy | yes |
| 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) | 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 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: