Framework for developing cost-effectiveness analysis threshold: the case of Egypt.

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.

Frequency and risk factors for headache disability: A population-based cross-sectional study in Egypt.

BACKGROUND: A headache is a very common condition that can have a significant impact on one's quality of life. It is one of the leading causes of years lived with disability worldwide. The objective of the study was to determine the prevalence of primary headache disability, its characteristics, risk factors and its impact on daily life. MATERIALS AND METHODS: A cross-sectional study was conducted in Fayoum governorate. The sample size was 1909 participants. A multistage random sample technique was used to select adults aged above 18 years. A self-structured questionnaire solicited information on sociodemographic characteristics, headache characteristics, and the headache disability index. SPSS v 22.0 was used for data analysis. RESULTS: Headaches caused complete disability in 19.5% of the study group, and 76.8% developed severe disability. Participants who reported that they had a headache more than once a week were; 44.5% had moderate pain and 40.2% had more intense pain. About 55% complained of attacks rather than continuous headache and were more likely to have a degree of complete disability, (P = 0.001). A statistically significant association was found between living in urban areas, working in professional occupations, complaining of severe headache in the form of an attack and seeking medical advice, with high scores of headache disability. CONCLUSION: Headache is a condition that affects the entire population in a way that causes high levels of disability. Good management is necessary for the reduction of the adverse effects of headaches on the health of the population. This should focus on raising public awareness by means of education and on the provision of basic healthcare.

Assessment of safe injection awareness and practices among healthcare providers at primary health care facilities.

BACKGROUND: Unsafe injection necessitates some preventive steps including promoting and assuring the execution of safe injection administration and waste disposal methods. The present study aimed to assess the awareness and practices of safe injection among health care providers working at all primary health care (PHC) facilities in Fayoum governorate, Egypt. Also, it assessed the awareness, readiness, and response related to needle stick injuries (NSIs). METHODS: A cross-sectional observational study conducted from September to December 2019 at all working PHC facilities in Fayoum Governorate, Egypt, resulted in enrolling 685 health care providers, and observation of 520 injection processes. Data were collected by a combination of staff interviews and structured observation of different injection processes using the WHO revised C tool. RESULTS: Safe injection and post-exposure NSI policies and procedures was implemented in 96.5% of the PHC facilities. Compliance to hand wash before preparing a procedure was 56.7%. Immediate disposal of used needles was 76.2% in observed injections. Hepatitis B vaccination rate among participants was 87.2%. Most participants 87.6% admitted the existence of a NSI reporting system but only 38.8% of those who had experienced NSI event reported. The rate of NSI was 14%. CONCLUSIONS: Fayoum PHC facilities have good awareness level among providers and broadly accepted compliance with injection practices as per the WHO tool. Most injection-safety aspects were satisfactory, and implemented measures to face NSI were in place. Appropriate timely actions are required to maintain the fair awareness and improve injections practices in the PHC facilities.

A multi-criteria decision analysis (MCDA) tool for purchasing off-patent oncology medicines in Egypt.

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.

Malnutrition and Its Associated Factors among Rural School Children in Fayoum Governorate, Egypt.

Malnutrition is an increasing health problem among children in developing countries. We assessed the level of malnutrition and associated factors among school children in a rural setting in Fayoum Governorate, Egypt. A school based cross-sectional survey was conducted on children (6-17 years) in Manshit El Gamal village in Tamia district of Fayoum Governorate. Weight, height, and age data were used to calculate z-scores of the three nutritional indicators using WHO anthroPlus. Sociodemographics and lifestyles Data were collected. Prevalence of stunting, underweight, and wasting was 34.2%, 3.4%, and 0.9%, respectively, while obesity was 14.9%. Prevalence of obesity was significantly higher in younger age group of 6-9 years in comparison with older age and was higher in males versus females in 10-13-year-age group. Increasing age, reduced poultry consumption, and escaping breakfast were associated factors for stunting with OR (95% CI) 1.27 (1.17-1.37), 2.19 (1.4-3.4), and 2.3 (1.07-5.03). Younger age and regular employment of the father were factors associated with obesity (OR = 0.753; 0.688-0.824 and OR = 2.217; 1.4-3.5). Malnutrition is highly prevalent in Fayoum in line with the national prevalence and associated with age, gender, regularity of father's employment, and dietary factors.

Economic Evaluation of the Combined Use of Warfarin and Low-dose Aspirin Versus Warfarin Alone in Mechanical Valve Prostheses.

BACKGROUND: The use of combined therapy of antiplatelet and anticoagulant versus anticoagulant alone to reduce instances of thromboembolic events in patients with heart valve prostheses is an established standard of care in many countries but not in Egypt. A previous Markov model cost-effectiveness study on Egyptian patients aged 50-60 years demonstrated that the combined therapy reduces the overall treatment cost. However, due to the lack of actual real-world data on cost-effectiveness and the limitation of the Markov model study to 50- to 60-year-old patients, the Egyptian medical community is still questioning whether the added benefit is worth the cost. OBJECTIVE: To assess, from the perspective of the Egyptian health sector, the cost-effectiveness of the combined use of warfarin and low-dose aspirin (75 mg) versus that of warfarin alone in patients with mechanical heart valve prostheses who began therapy between the age of 15 and 50 years. METHODS: An economic evaluation was conducted alongside a randomized, controlled trial to assess the cost-effectiveness of the combined therapy in patients with mechanical valve prostheses. A total of 316 patients aged between 15 and 50 years were included in the study and randomly assigned to a group treated with both warfarin and aspirin or a group treated with warfarin alone. RESULTS: The patients in the combined therapy group exhibited a significantly longer duration of protection against the first event. Fewer primary events were observed in the patients treated with warfarin plus aspirin than in those treated with warfarin alone (1.4 %/year, vs. 4.8 %/year), and a higher mean quality-adjusted life-years (QALYs) value over 4 years was obtained for the group treated with warfarin plus aspirin (difference 0.058; 95 % CI 0.013-0.118), although this difference did not reach a conventional level of statistical significance. The total costs over a 4-year period were lower with the combined therapy (difference -US$244; 95 % CI -US$483.1 to -US$3.8), which yielded an incremental cost-effectiveness ratio of -US$4206 per QALY gained. Thus, the combined therapy was dominant. All costs were reported in US dollars (USD) for the financial year 2014. CONCLUSIONS: The results of this analysis indicate that from the perspective of the Egyptian health sector, the addition of aspirin to the typical warfarin therapy is more effective and less costly for patients with mechanical valve prostheses than treatment with warfarin alone. This combined strategy could be adopted to prevent the complications of mechanical valve prostheses. Our study adds to the body of evidence supporting the option of warfarin-plus-aspirin therapy for patients with mechanical valve prostheses.

Indirect treatment comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report.

Despite the great realized or potential value of network meta-analysis of randomized controlled trial evidence to inform health care decision making, many decision makers might not be familiar with these techniques. The Task Force developed a consensus-based 26-item questionnaire to help decision makers assess the relevance and credibility of indirect treatment comparisons and network meta-analysis to help inform health care decision making. The relevance domain of the questionnaire (4 questions) calls for assessments about the applicability of network meta-analysis results to the setting of interest to the decision maker. The remaining 22 questions belong to an overall credibility domain and pertain to assessments about whether the network meta-analysis results provide a valid answer to the question they are designed to answer by examining 1) the used evidence base, 2) analysis methods, 3) reporting quality and transparency, 4) interpretation of findings, and 5) conflicts of interest. The questionnaire aims to help readers of network meta-analysis opine about their confidence in the credibility and applicability of the results of a network meta-analysis, and help make decision makers aware of the subtleties involved in the analysis of networks of randomized trial evidence. It is anticipated that user feedback will permit periodic evaluation and modification of the questionnaire.

Questionnaire to assess relevance and credibility of modeling studies for informing health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report.

The evaluation of the cost and health implications of agreeing to cover a new health technology is best accomplished using a model that mathematically combines inputs from various sources, together with assumptions about how these fit together and what might happen in reality. This need to make assumptions, the complexity of the resulting framework, the technical knowledge required, as well as funding by interested parties have led many decision makers to distrust the results of models. To assist stakeholders reviewing a model's report, questions pertaining to the credibility of a model were developed. Because credibility is insufficient, questions regarding relevance of the model results were also created. The questions are formulated such that they are readily answered and they are supplemented by helper questions that provide additional detail. Some responses indicate strongly that a model should not be used for decision making: these trigger a "fatal flaw" indicator. It is hoped that the use of this questionnaire, along with the three others in the series, will help disseminate what to look for in comparative effectiveness evidence, improve practices by researchers supplying these data, and ultimately facilitate their use by health care decision makers.

Cost-Effectiveness of the Combined Use of Warfarin and Low-Dose Aspirin versus Warfarin Alone in Egyptian Patients with Aortic Valve Replacements: A Markov Model.

BACKGROUND: The combination of antiplatelet and anticoagulant therapy significantly reduces the rate of thromboembolic events in patients with heart valves compared with anticoagulant therapy alone. Cost-effectiveness of this therapy in Egypt, however, has not yet been established. OBJECTIVE: The aim of the present study was to evaluate the cost-effectiveness of the combined use of warfarin and low-dose aspirin (100 mg) versus warfarin alone in patients with mechanical aortic heart valve prostheses who began therapy at the age of 50 to 60 years over a 5-year period from the perspective of the medical providers. METHODS: A cohort Markov process model with five health states (recovery, reoperation, bleeding, thromboembolism, and death) based on Egyptian clinical practice was derived from published sources. The clinical parameters were derived from meta-analyses of randomized controlled trials of patients with mechanical valve prostheses. The quality of life of the health states was derived using the available published data. Direct medical costs were obtained from four top-rated governmental cardiology hospitals in Egypt. All costs and effects were discounted at 3.5% annually. All costs were converted using the purchasing power parity rate and are reported in US $ for the financial year of 2013. RESULTS: The total quality-adjusted life-years (QALYs) were estimated to be 1.1616 and 1.1199 for the warfarin plus aspirin group and the warfarin group, respectively, which resulted in a difference of 0.0416 QALYs. The total costs for the warfarin plus aspirin group and the warfarin group were US $307.33 and US $315.25, respectively (the difference was US $7.92), which yielded an incremental cost-effectiveness ratio of -190.38 for the warfarin plus aspirin group. Thus, the combined therapy was dominant. Various one-way sensitivity analyses indicated that probabilities of reoperation and bleeding in the recovery state had the greatest effects on incremental costs. The model parameters that had the greatest effects on incremental QALYs were the relative risk reduction of death and the utility value in the recovery state. CONCLUSIONS: The present study is the first cost-utility analysis to conclude that, from the perspective of Egyptian medical providers, combined therapy is more effective and less costly than warfarin alone for patients with mechanical aortic valve prostheses. For clinicians and patients who choose to focus on minimizing thromboembolic risk, these results suggest that combined therapy offers the best protection. This study helps to inform decisions about the allocation of health care system resources and to achieve better health in the Egyptian population.

Recommendations for Reporting Pharmacoeconomic Evaluations in Egypt.

OBJECTIVE: Introduction of economic evaluations for pharmaceuticals or other health technologies can help the optimization of outcomes from resource allocations. This article aims to provide recommendations for researchers in presenting pharmacoeconomic evaluations in Egypt with special focus on pricing and/or reimbursement applications of pharmaceuticals. METHODS: The Minister of Health approved the initiative of establishing a focus group of decision makers that included academic and industry experts with experience in health economics, pharmacovigilance, and clinical pharmacy. The focus group has reviewed 17 economic evaluation guidelines available on the Web site of the International Society for Pharmacoeconomics and Outcomes Research for reporting health economic evaluations. To develop core assumptions before preparing a draft report, focus group meetings were held on a regular basis starting June 2012. The recommendations were developed by using the Quasi-Delphi method, taking into account current practices and capacities for conducting pharmacoeconomic evaluations in Egypt. CONCLUSIONS: Worldwide, health care decision makers are challenged to set priorities in an environment in which the demand for health care services outweighs the allocated resources. Effective pharmaceutical pricing and reimbursement systems, based on health technology assessment (HTA) that encompasses economic evaluations, are essential to an efficient sustainable health care system. The Egyptian Ministry of Health and Population was encouraged to establish a pharmacoeconomic unit, as an initial step, for the support of pricing and reimbursement decisions. We anticipate that standardization of reporting would lead to a progressive improvement in the quality of submissions over time and provide the Egyptian health care system with health economic evidence often unavailable in the past. Therefore, recommendations for pharmacoeconomic evaluations provide an essential tool for the support of a transparent and uniform process in the evaluation of the clinical benefit and costs of drugs that do not rely on the use of low acquisition cost as the primary basis for selection. These recommendations will help inform health care decisions in improving health care systems and achieving better health for the Egyptian population.