Strategic Approaches to Reducing the Burden of Atopic Dermatitis in the Middle East and Africa Region.

OBJECTIVES: Atopic dermatitis (AD) creates a significant burden on patients and society. This study proposes a set of health policy interventions that can reduce the burden of AD in the Middle East and Africa. METHODS: We conducted a scoping review to find relevant actions that have been implemented or recommended to decrease AD burden globally. An expert panel was conducted to discuss the review findings, then experts were surveyed to suggest the most efficient actions. Finally, survey results and recommendations were formulated into key actions to reduce the burden in the Middle East and Africa region. RESULTS: Recommended actions were related to 5 domains; capacity building, guidelines, research, public awareness, and patient support and education. Several actions related to each domain can help reduce the burden. One of the most advocated recommendations was investing in patient education through trained healthcare professionals. Understanding the disease and learning how to control it is a key cornerstone to treatment optimization and reducing the burden. Multidisciplinary care, publishing defined therapeutic guidelines, and investing in research were the most recommended actions based on the experts' discussion and survey results. CONCLUSIONS: Although the burden of AD is the highest among dermatological diseases, a well-grounded action plan has the potential to reduce the disease burden. Decision makers may develop a national AD action plan by selecting the most relevant items of this study based on their potential impact, feasibility, timeliness, and affordability.

Development of the Emirates Multi-Criteria Decision Analysis Tool for Orphan Drugs.

Background The number of orphan drug approvals is currently increasing globally. This creates a significant burden on payers and healthcare systems. This study aimed to create a multi-criteria decision analysis (MCDA) tool for evaluating orphan drugs within the United Arab Emirates (UAE). The intended result of the tool is to provide evidence-based guidance to decision-makers in reimbursement and procurement decisions. Methods We conducted a literature search and local expert interviews to identify relevant preliminary criteria for the MCDA tool. Then we conducted a structured consensus-building session for healthcare experts and decision-makers in the UAE to develop the Emirati MCDA tool for orphan drugs. The experts voted for the criteria to be included in the tool and their ranking according to importance, as well as the weight of each criterion and its scoring function. To improve understanding and facilitate the voting process, experts were provided with a brief illustration of similar tools conducted in other countries before the voting sessions. Finally, the tool was developed in a Microsoft Excel sheet (Microsoft Corporation, Redmond, Washington, United States), and it was validated and tested based on real case studies, then it was fine-tuned accordingly based on the experts' discussions. The final tool was provided to the attendees to guide their decisions in the reimbursement and procurement of orphan drugs. Results The created tool provides a score for each analyzed orphan drug based on its value. Ten criteria were included in the final MCDA tool. These were cost-effectiveness (25.1% of the weight), magnitude of health gain (20.1%), availability of therapeutic alternative (14.3%), disease severity (11%), budget impact (7.9%), disease rarity (5.6%), strength of clinical evidence (5.6%), burden on households (4.5%), indication uniqueness (3.2%), and patients' age (2.6%). Conclusions Implementation of evidence-based healthcare necessitates assessing the fair value of each health technology. Addressing the high unmet medical needs and improving healthcare for patients with rare diseases are priorities within the UAE. The created Emirates MCDA tool for orphan drugs has the potential to help decision-makers implement value-based and evidence-based reimbursement decisions for orphan drugs.

Maximizing the benefits of using biosimilars in Egypt.

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.

Humanistic and Economic Burden of Atopic Dermatitis for Adults and Adolescents in the Middle East and Africa Region.

INTRODUCTION: Atopic dermatitis (AD) is a chronic skin disease that poses a significant burden on both patients and the society. AD causes the highest loss in disability-adjusted life years compared with other skin diseases. This study aimed to estimate the economic and humanistic burden of AD in adults and adolescents in seven countries in the Middle East and Africa region (Egypt, Lebanon, Saudi Arabia, Kuwait, Algeria, South Africa, and United Arab Emirates). METHODS: We conducted a literature review to identify country-specific data on this disease. Subsequently, meetings were organized with experts from each country to complete the missing data. The data were aggregated and calculation models were created to estimate the value of the humanistic and economic burden of the disease in each country. Finally, we conducted meetings with local experts to validate the results, and the necessary adjustments were made. RESULTS: On average, a patient with AD loses 0.19 quality-adjusted life years (QALYs) annually owing to this disease. The average annual healthcare cost per patient is highest in the United Arab Emirates, with an estimated value of US $3569 and a population-level indirect cost of US $112.5 million. The included countries allocated a range of 0.20-0.77% of their healthcare expenditure to AD-related healthcare services and technologies. The indirect cost of AD represents approximately 67% of the total disease cost and, on average, approximately 0.043% (range 0.022-0.059%) of the gross domestic product (GDP) of each country. CONCLUSION: Although the humanistic and economic burdens differ from country to country, AD carries a significant socioeconomic burden in all countries. The quality of life is severely affected by the disease. If AD is controlled, the costs, especially indirect costs, could decrease and the disease burden could be alleviated significantly.

Atopic dermatitis is a chronic condition characterized by inflamed and itchy skin. The prevalence and symptoms of atopic dermatitis are observed to increase in dry weather. Owing to its high prevalence in children, the majority of studies on atopic dermatitis are in children. Although it is also prevalent in adults and adolescents, its burden on adults has not been sufficiently studied, especially in Africa and the Middle East. This study quantified the burden of atopic dermatitis in adults and adolescents in seven countries in the Middle East and Africa. We estimated the economic and humanistic burden of this disease. We conducted a literature review and expert interviews to determine the effects on patients and caregivers. We created mathematical models to calculate the disease burden in each country, and local experts in each country validated the data. The study results showed that atopic dermatitis significantly affects the quality of life of patients. The direct medical costs of treatment in each country were calculated. The management of atopic dermatitis consumes around 0.20­0.77% of the healthcare expenditure in a country. The indirect cost of atopic dermatitis represents 0.022­0.059% of the gross domestic product (GDP) of a country. The country-specific burden data are essential to guide decision-makers in arriving at evidence-based decisions and efficiently allocating available resources. This study focused on the significant indirect economic burden of the disease, which can sometimes be underestimated because the disease is not fatal.

A roadmap toward implementing health technology assessment in Egypt.

Background: The Egyptian healthcare system is currently in the early phase of health technology assessment (HTA) implementation. The aim of this study is to propose an implementation roadmap based on the national healthcare system status. Methods: A survey was conducted among Egyptian healthcare sector decision-makers to assess the current and future (preferred) HTA implementation status in Egypt based on a widely used international scorecard methodology. Subsequently, interviews were conducted with experts representing middle- and top-tier management in the Egyptian healthcare system to interpret the survey results and recommend specific actions. Results: Experts recommended more capacity-building programs for HTA and health economics. Additionally, they proposed establishing HTA units in separate healthcare authorities and merging them into a single central HTA unit in the long term. Regarding the scope of implementation, experts recommended commencing with the assessment of innovative pharmaceuticals, and thereafter, expanding the scope to cover all health technologies in the long term. Additionally, they recommended using innovative tools such as "multi-criteria decision analysis (MCDA)" for tendering, and "managed entry agreements" for reimbursement decisions. Local burden of diseases and costing studies were also recommended to facilitate the implementation of HTA. Conclusion: Experts agreed that several actions are required for successful HTA implementation in Egypt, including coordination between HTA bodies, application of an explicit MCDA framework, and strengthening of local evidence generation. To implement these actions, investment in technical capacity-building is indispensable. Most experts favored using multiple and soft cost-effectiveness thresholds. Efforts should be made to publish HTA submission guidelines and timelines of the processes.

The humanistic and economic burden of atopic dermatitis among adults and adolescents in Saudi Arabia.

Aims: Atopic dermatitis (AD) is a chronic skin disease that creates a significant burden to patients and society. There is scarcity in local data about the burden of AD in the Kingdom of Saudi Arabia (KSA). We aimed to fill in this gap and quantify the humanistic and economic burden of AD among adults and adolescents in KSA.Materials and methods: A literature search and local expert interviews were conducted to assess the disease burden. Prevalence values were estimated through the literature. International data about health-related quality of life lost owing to AD was adjusted to age and prevalence in KSA. Direct and indirect costs were calculated using a bottom-up approach. Resource utilization data were collected from local dermatologists through online interviews, and indirect costs were based on absenteeism and presenteeism estimates. Validation meetings were conducted with local experts to adjust the final estimates.Results: The age-standardized health loss per patient due to AD is 0.187 quality-adjusted life-years (QALYs) annually, aggregating to 64 thousand lost QALYs in KSA. The annual average direct cost for a patient with AD was 2924 Saudi Riyal (SAR; 780 USD), totaling 373 million SAR in KSA (99.5 million USD). This value represents 0.2% of the annual health expenditure in KSA. The total productivity loss due to AD was 1.36 billion SAR (363.7 million USD). Overall, the economic burden of AD consumes up to 0.059% of the national gross domestic product.Limitations: Local quality of life and productivity lost data were not available for KSA, so global averages were used, assuming these numbers also apply to KSA.Conclusion: Indirect costs represent a large proportion of AD burden in KSA. The disease has a substantial effect on patient quality of life and social well-being. Alleviating the burden might result in significant savings in resources to society.

Atopic dermatitis is one of the most common skin diseases. Mild cases of the disease cause inflamed and itchy skin, while severe cases may cause painful episodes of itching and cracked skin. Patients with atopic dermatitis and their families suffer lower quality of life as the severity of the disease increases. In countries with hot weather like Saudi Arabia, skin is more susceptible to become dry, so the disease is very prevalent. Therefore, the disease poses a significant quality of life burden as well as an economic burden due to the direct costs of treatment and the indirect costs that arise because patients become non-productive or absent from work or school. Our study aimed to quantify the economic and quality of life burden of atopic dermatitis in Saudi Arabia to understand it's real burden and help decision makers quantify its impact on the patients and society. We conducted a literature search and interviewed local experts to determine estimates of costs and quality of life effects. The results of this study should help in prioritizing treatment disease areas in Saudi Arabia and other countries with similar circumstances.

A multicriteria decision analysis (MCDA) tool to purchase implantable medical devices in Egypt.

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.

Burden of Atopic Dermatitis in Adults and Adolescents: a Systematic Literature Review.

INTRODUCTION: Although previously regarded as a children's disease, it is clear that atopic dermatitis (AD) is also highly prevalent in adults. Because AD is not associated with mortality, it is usually neglected compared with other, fatal diseases. However, several studies have highlighted that AD burden is significant due to its substantial humanistic burden and psychosocial effects. This study aims to summarize and quantify the clinical, economic, and humanistic burden of AD in adults and adolescents. METHODS: A systematic literature search was performed in PubMed, Scopus, Cochrane, Centre for Reviews and Dissemination (CRD), EconPapers, The Professional Society for Health Economics and Outcomes Research (ISPOR), The National Institute for Health and Care Excellence (NICE), and The Canadian Agency for Drugs and Technologies in Health (CADTH). Studies were included if they reported clinical, economic, or humanistic effects of AD on adults or adolescents, from January 2011 to December 2020. The Grading of Recommendations Assessment tool was used to assess risk of bias for the included studies. Regression models were used to explain the correlation between factors such as disease severity and quality of life (QoL). RESULTS: Among 3400 identified records, 233 studies were included. Itch, depression, sleep disturbance, and anxiety were the most frequently reported parameters related to the clinical and humanistic burden of AD. The average utility value in studies not stratifying patients by severity was 0.779. The average direct cost of AD was 4411 USD, while the average indirect cost was 9068 USD annually. CONCLUSIONS: The burden of AD is significant. The hidden disease burden is reflected in its high indirect costs and the psychological effect on QoL. The magnitude of the burden is affected by the severity level. The main limitation of this study is the heterogeneity of different studies in terms of data reporting, which led to the exclusion of potentially relevant data points from the summary statistics.

Atopic dermatitis is a very common skin disease among children and adults. The disease is nonfatal but may lead to patients and families having a low quality of life and decreased productivity, especially in its severe state. Because atopic dermatitis is more common in children than adults, most published research is directed to studying the effect of the disease on children. Atopic dermatitis affects patients' health, quality of life, financial state, and productivity. Therefore, our study aims to study and quantify the burden caused by the disease represented in the clinical burden, humanistic burden, and economic burden. We conducted a systematic literature review to determine all relevant studies providing specific values for the burden. The studies included are those providing information on the percentage of patients affected by specific symptoms, costs paid for treatment, number of days of productivity lost due to the disease, and quality-of-life questionnaire results for patients with atopic dermatitis or their caregivers. We analyzed the data from all relevant studies to calculate average values and quantify the burden. The results of our study should help healthcare sector decision-makers in understanding the real effect of the disease on adults and adolescents and rearrange their priorities for treating different diseases based on the specific burden of each disease.

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.

Healthcare financing in Egypt: a systematic literature review.

BACKGROUND: The Egyptian healthcare system has multiple stakeholders, including a wide range of public and private healthcare providers and several financing agents. This study sheds light on the healthcare system's financing mechanisms and the flow of funds in Egypt. It also explores the expected challenges facing the system with the upcoming changes. METHODS: We conducted a systematic review of relevant papers through the PubMed and Scopus search engines, in addition to searching gray literature through the ISPOR presentations database and the Google search engine. Articles related to Egypt's healthcare system financing from 2009 to 2019 were chosen for full-text review. Data were aggregated to estimate budgets and financing routes. RESULTS: We analyzed the data of 56 out of 454 identified records. Governmental health expenditure represented approximately one-third of the total health expenditure (THE). Total health expenditure as a percent of gross domestic product (GDP) was almost stagnant in the last 12 years, with a median of 5.5%. The primary healthcare financing source is out-of-pocket (OOP) expenditure, representing more than 60% of THE, followed by government spending through the Ministry of Finance, around 37% of THE. The pharmaceutical expenditure as a percent of THE ranged from 26.0 to 37.0%. CONCLUSIONS: Although THE as an absolute number is increasing, total health expenditure as a percentage of GDP is declining. The Egyptian healthcare market is based mainly on OOP expenditures and the next period anticipates a shift toward more public spending after Universal Health Insurance gets implemented.

The Burden of Obesity in Egypt.

Objective: Estimating the burden of obesity to society is an essential step in setting priorities and raising awareness. We aimed to assess the clinical, humanistic and economic burden of obesity for adults in Egypt. Methods: We used the population attributable fraction concept to estimate the burden. A non-systematic review was conducted to estimate the prevalence of obesity and its comorbidities in addition to the obesity attributable fraction. Patient numbers, direct healthcare costs, disability adjusted life years (DALYs) and attributable mortality were estimated. Results: Obesity is a major contributor to the development of diabetes mellitus, hypertension, obstructive sleep apnea and fatty liver, in addition to several serious diseases. The estimated annual deaths due to obesity was about 115 thousand (19.08% of the total estimated deaths in 2020). DALYs attributable to obesity may have reached 4 million in 2020.The economic burden imposed by obesity is around 62 Billion Egyptian pounds annually. This value is the cost of treating diseases attributable to obesity in adults. Conclusions: Diseases attributable to obesity create a huge economic, humanistic, and clinical burden in Egypt. Reducing obesity could help dramatically decrease the catastrophic health effect of these diseases which in turn decreases mortality and DALYs lost.

Criteria and Scoring Functions Used in Multi-criteria Decision Analysis and Value Frameworks for the Assessment of Rare Disease Therapies: A Systematic Literature Review.

BACKGROUND: Traditionally, the economic value of health technologies is assessed with cost-effectiveness (CE) and budget impact (BI) analyses. However, the evaluation of rare disease therapies often considers novel value criteria. Multi-criteria decision analysis (MCDA) is a promising tool in the assessment of value criteria that typically cannot be captured with traditional approaches. OBJECTIVES: The objective of this research was to investigate the criteria and scoring functions applied in value frameworks and MCDA tools relevant to the evaluation of rare disease therapies. The aim was to gain a better understanding of the domains and measurement of commonly referenced novel value criteria. METHODS: A systematic literature review was performed covering the period from 2013 to 2019. MCDA or value framework articles and structured review papers on orphan-drug-specific MCDA articles were reviewed. Information sources included MEDLINE, Embase, Scopus, and 26 other gray literature sources. A descriptive review of identified criteria and scoring functions was performed, with special focus on "novel" value criteria that are traditionally not considered in CE or BI analyses. RESULTS: In total, 15 relevant value frameworks and MCDA tools were identified. These studies included a large number (n = 56) of individual value criteria. The most commonly included novel criteria were unmet medical need, severity of disease, and reduction in uncertainty. The identified scoring functions (measurement methods) for novel criteria were highly heterogeneous and tailored. Standardized scoring functions were not observed. Additionally, the studies did not provide their rationale for choosing a specific scoring function for a criterion. CONCLUSIONS: MCDA is a promising tool to include novel value criteria into the health technology assessment of therapies for rare diseases. To support the development of a transparent and justified evaluation process, scoring functions should be further investigated.

Potential Criteria for Frameworks to Support the Evaluation of Innovative Medicines in Upper Middle-Income Countries-A Systematic Literature Review on Value Frameworks and Multi-Criteria Decision Analyses.

BACKGROUND: Multicriteria Decision Analysis (MCDA), a formal decision support framework, has been growing in popularity recently in the field of health care. MCDA can support pricing and reimbursement decisions on the macro level, which is of great importance especially in countries with more limited resources. OBJECTIVES: The aim of this systematic review was to facilitate the development of future MCDA frameworks, by proposing a set of criteria focusing on the purchasing decisions of single-source innovative pharmaceuticals in upper middle-income countries. METHODS: A systematic literature review was conducted on the decision criteria included in value frameworks (VFs) or MCDA tools. Scopus, Medline, databases of universities, websites of Health Technology Assessment Agencies, and other relevant organizations were included in the search. Double title-abstract screening and double full-text review were conducted, and all extracted data were double-checked. A team of researchers performed the merging and selection process of the extracted criteria. RESULTS: A total of 1,878 articles entered the title and abstract screening. From these, 341 were eligible to the full-text review, and 36 were included in the final data extraction phase. From these articles 394 criteria were extracted in total. After deduplication and clustering, 26 different criteria were identified. After the merging and selection process, a set of 16 general criteria was proposed. CONCLUSION: Based on the results of the systematic literature review, a pool of 16 criteria was selected. This can serve as a starting point for constructing MCDA frameworks in upper middle-income countries after careful adaptation to the local context.