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Introduction: To improve resource allocation within our healthcare system, the Egyptian Authority for Unified Procurement, Medical Supply and the Management of Medical Technology (UPA) and Universal Health Insurance Authority (UHIA) established a joint economic evaluation process to support UHIA reimbursement decisions and UPA procurement decisions. The main objective of this study is to describe the developed national pharmacoeconomic guidelines in Egypt, especially for reimbursement and procurement for new pharmaceuticals., Methods: A focus group was formed as a national initiative activity by governmental authorities in Egypt. The aim of this focus group was to develop national pharmacoeconomic guidelines for the evaluation of innovative and high-budget pharmaceutical products. This group consisted of various stakeholders with experience in health economics, outcomes research, public health, and pharmacy practice. To develop our national pharmacoeconomic guidelines, three steps were taken. First, the focus group reviewed the European Network for Health Technology Assessment (EUnetHTA) methods for health economic evaluations for new pharmaceuticals as well as the Canadian Agency for Drugs and Technologies in Health (CADTH) guidelines and the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions. Second, the focus group used the EUnetHTA guideline as a reference and adapted it to our local context. The focus group added the value assessment component, using the CADTH and AMCP guidelines. Third, the focus group collected input and feedback from key stakeholders through a focus group by using the quasi-Delphi panel approach., Results: The results of the focus group are a main structure of national pharmacoeconomic guidelines for the evaluation of innovative and high-budget pharmaceutical products, consisting of seven main topics., Conclusion: Economic evaluation is a core element of Health Technology Assessment, (HTA); therefore, the UHIA and UPA were encouraged to produce unified joint pharmacoeconomic guidelines for innovative products as an initial step in their commitment to implement the use of HTA in decision-making. This standardization of guidelines not only ensures transparency but also guarantees an accurate and transparent process to support evidence-based decision-making. These guidelines are expected to help decision-makers improve their process and attain better health outcomes for Egyptian patients., Competing Interests: Source of Support: None. Conflict of Interest: None.

Background: Cost-effectiveness analyses rarely offer useful insights to policy decisions unless their results are compared against a benchmark threshold. The cost-effectiveness threshold (CET) represents the maximum acceptable monetary value for achieving a unit of health gain. This study aimed to identify CET values on a global scale, provide an overview of using multiple CETs, and propose a country-specific CET framework specifically tailored for Egypt. The proposed framework aims to consider the globally identified CETs, analyze global trends, and consider the local structure of Egypt's healthcare system., Methods: We conducted a literature review to identify CET values, with a particular focus on understanding the basis of differentiation when multiple thresholds are present. CETs of different countries were reviewed from secondary sources. Additionally, we assembled an expert panel to develop a national CET framework in Egypt and propose an initial design. This was followed by a multistakeholder workshop, bringing together representatives of different governmental bodies to vote on the threshold value and finalize the recommended framework., Results: The average CET, expressed as a percentage of the gross domestic product (GDP) per capita across all countries, was 135%, with a range of 21 to 300%. Interestingly, while the absolute value of CET increased with a country's income level, the average CET/GDP per capita showed an inverse relationship. Some countries applied multiple thresholds based on disease severity or rarity. In the case of Egypt, the consensus workshop recommended a threshold ranging from one to three times the GDP per capita, taking into account the incremental relative quality-adjusted life years (QALY) gain. For orphan medicines, a CET multiplier between 1.5 and 3.0, based on the disease rarity, was recommended. A two-times multiplier was proposed for the private reimbursement threshold compared to the public threshold., Conclusion: The CET values in most countries appear to be closely related to the GDP per capita. Higher-income countries tend to use a lower threshold as a percentage of their GDP per capita, contrasted with lower-income countries. In Egypt, experts opted for a multiple CET framework to assess the value of health technologies in terms of reimbursement and pricing., (© 2024. The Author(s).)

Background: Biosimilars constitute a pathway for sustainable financing of healthcare systems in the era of expensive biologics. However, such a pathway is not free of challenges. Since the biosimilars market is expanding in Egypt, there is an urgent need for a policy framework to optimize their use and diffusion in the market. We aim to characterize a national framework based on the experiences of other countries and consultation with local experts., Methods: A narrative literature review was conducted to identify biosimilars' policy elements worldwide. A workshop was organized with experts to discuss the narrative review findings and create consensus on recommendations., Results: The narrative literature review highlighted the need for biosimilar policy actions in four areas: market authorization, pricing, reimbursement, and uptake. Eighteen experts representing the Egyptian healthcare authorities attended the workshop. The most significant conclusions from the workshop included setting the price of the biosimilar at 30-40% less than its originator's price and establishing financing protocols, in which the more expensive biologics with significant price premiums should be excluded from the formulary., Conclusions: A summarized national framework policy recommendation for biosimilars was created by local experts from the main public healthcare entities in Egypt. These recommendations coincide with the international policies adopted across different countries that aim to improve patient access while sustaining health expenditure., (© 2023. The Author(s).)

Background: With the availability of several similar medical devices performing the same function, choosing one for reimbursement is not easy, especially if purchased for a large number of patients. The objective of this project was to create a multicriteria decision analysis (MCDA) tool, that captures and compares all implantable medical devices' attributes, to provide an objective method for choosing among the available options in Egypt., Method: We conducted a systematic review and expert interviews, to identify the relevant criteria for inclusion in the tool. Subsequently, a workshop was conducted, that involved experts in procuring and tendering medical devices. Experts chose the criteria, ranked them, assigned weights and scoring functions for each criterion, and then created the draft tool. A pilot phase followed; then, another workshop was conducted to fine-tune the tool. We readjusted the tool based on experts' experience with the draft tool., Results: The final tool included eight criteria, arranged according to their weightage: technical characteristics (29.4%), country of origin (19.5%), use in reference countries (14.9%), supply reliability (11.7%), previous use in tenders (9.0%), instant replacement within product variety (6.9%), pharmacovigilance (4.6%), and refund or replacement (4.0%). Each medical device was assessed on these eight criteria to achieve a final score, that was compared to the alternative devices' scores. Price is not included in the MCDA tool, but it will be added in the financial evaluation phase., Conclusion: Decisionmakers could use the MCDA tool, to make evidence-based and objective decisions for purchasing implantable devices, in the Egyptian public sector. Post price evaluation, the product with the best value will be chosen for reimbursement., Highlights: We created an MCDA tool to help decision makers choose between alternative implantable medical devices in Egypt. The MCDA tool includes eight criteria, where price is evaluated as a separate step. "Technical characteristics" and "country of origin" criteria carried the highest weights, thus representing approximately 50% of the decision., (© 2022. The Author(s).)

Objective: To conduct a situational analysis with the aim to inform future health technology assessment efforts (HTA) in Egypt. Introduction: The Egyptian government has set universal health coverage as a 2030 target. Several agencies have been created in the context of the ongoing healthcare reform. The Egyptian Authority for Unified Procurement, Medical Supply and the Management of Medical Technology (UPA) is one of them and was established to support strategic procurement using HTA. Methods: Description of the development of HTA in Egypt supported by a literature search as part of a scoping exercise, and a stakeholder analysis and identification of HTA capacity survey, based on previous surveys, with relevant stakeholders conducted in 2022. This was followed by a stakeholder event where results were shared and further contextualized. Results: The UPA is expected to evaluate the cost-effectiveness of health technologies and public health programs. The HTA process is being developed, focusing on the assessment of the value of new pharmaceuticals being introduced to the Egyptian market. A total of 16 participants responded on behalf of their organizations to the stakeholder analysis and identification of HTA capacity survey. More than 80% of the respondents were familiar with current efforts conducted by UPA and strongly support the implementation of HTA in Egypt. Transparency was highlighted as an important criterion. Over 90% of the respondents mentioned economic analyses as an HTA product being developed in Egypt, and medicines were the type of technology that stakeholders ranked as first in the rank of health technologies that need the output from HTA urgently. Capability building and training were highlighted as areas in which further support is required. Conclusion: This study represents the first attempt to describe the current path for HTA in Egypt. There seems to be momentum in Egypt to proceed and advance with HTA institutionalization. It would be important that next steps are built on the skills and capabilities already in place in Egypt, ensure methods and processes are in place and up to date and involve the wider system in Egypt so stakeholders can appropriately contribute and participate in the HTA process., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Pinilla-Dominguez, Taha, McGuire, Elagamy, Sedrak, Gamal, Eldebeiky and Dawoud.)

Background: Multi- criteria decision analysis (MCDA) can assist policymakers in objectively choosing between alternative therapeutic options based on multiple value attributes. Our aim was to create an MCDA tool for the national tenders of off-patent oncology medicines in Egypt., Methods: An initial list of criteria was developed through a literature review complemented by local expert interviews. Price or cost-related criteria were excluded to abide by the national regulations of the tender process. Next, a workshop hosting diversified stakeholders representing different governmental bodies was held. Anonymous voting was used to rank and weigh the criteria as well as assigning scores. Price was added as a separate step to identify best option based on price per point. The tool was then tested on a national tender sample of off-patent oncology medicines to assess its performance, and it was readjusted accordingly in a second workshop., Results: Seven non-price criteria were selected, including use in reference countries (23.49% weight), equivalence with the reference product (18.79%), manufacturing quality (15.53%), provision of pharmacovigilance services (12.94%), supply reliability (10.78%), previous use in local settings (9.8%) and macroeconomic benefit (8.67%). A medicine receives a score ranging from 0 to 100% of each criterion's weight. The aggregated score is calculated on a hundred-point scale. Based on participants' consensus, an overall score of 65 was set as a cut-off for passing the technical eligibility phase of the tendering process. Any product receiving a lower score would be disqualified from the tender. For qualified products, the lower price per point represents preferential option for the national tender., Conclusions: The created MCDA tool is capable of objectively comparing similar off-patent oncology medicines by considering multiple value attributes and providing reliable scoring functions for each., (© 2022. The Author(s).)

Purpose: To identify anatomical aberrations following PSARP procedure by using MRI, while correlating MRI findings to clinical outcome., Patients and Methods: Between January 2014 and December 2017, we conducted our study on male patients with rectourethral fistula who underwent PSARP. Postoperative pelvic MRI studies were performed and correlated to their clinical continence scores (Rintala, and Krickenbeck classification)., Results: The study included 31 patients. Fourteen patients were retrieved from the hospital records and accepted to participate in the study; while the remaining 17 were collected from the fecal incontinence clinic. Their age ranged from 40 to 156 months (mean 83) We divided patients in the study into two groups according to their Rintala continence scores: (Group A) 15 patients with low scores (10 or less); and (Group B) 16 patients with higher scores (more than 10). We detected wider pelvic hiatus (hiatus/PC ratio) and more obtuse anorectal angle in group A than B., Conclusion: Several anatomical alterations can be detected by MRI following the PSARP procedure that include abnormalities in the striated muscle sphincter (attenuation/deficiency), deviated neorectum, and presence of excessive perirectal fat. A widened pelvic hiatus and/or obtuse anorectal angle may correlate with poor fecal continence in these patients., Level of Evidence: This is a case control study (level III evidence)., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Long-term follow-up has substantiated the colon as a durable and highly acceptable esophageal substitute. Exposure of colonic conduit to gastric acid may lead to histopathologic changes in the form of chronic inflammation., Materials/methods: Thirty children with esophageal replacement were studied from 2 to 12 years (mean, 5.20 years) postoperatively. All cases underwent upper gastrointestinal tract endoscopy to evaluate the gross appearance of colonic conduit mucosa, and punch biopsies were taken from upper and lower junctions of the conduit. All biopsies were submitted to histopathologic examination., Results: Endoscopic findings were comparable with normal regarding the gross appearance of colonic mucosa in both upper and lower junctions (25 cases/83.3%). Some abnormalities were seen including cervical anastomosis stricture (2 cases/6.7%), redundancy (3 cases/10%), mucosal ulcer in the lower residual esophagus (1 case/3.3%), and hyperemia (3 cases/10%). Pathologic changes were minimal regarding the change in position of the colon to a thoracic organ during follow-up. Most of the cases were normal (22 cases/73.3%). Seven cases (23.4%) showed mild chronic nonspecific inflammation of the colonic mucosa, whereas only 1 case (3.3%) showed mildly active inflammation of colonic mucosa., Conclusion: The use of the colon for esophageal replacement showed that no significant pathologic changes affecting its function as a conduit because its mucosa showed no significant change in response to gastric acid reflux in long-term follow-up and can be further protected by an antireflux procedure., (Copyright © 2012 Elsevier Inc. All rights reserved.)