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.

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.

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.

Recommendation for a Pilot MCDA Tool to Support the Value-Based Purchasing of Generic Medicines in the UAE.

Introduction: In recent periods the United Arab Emirates (UAE) has strengthened economic measures in its pharmaceutical policy by promoting local manufacturing and facilitating the use of generic medicines. International examples indicate the importance of quality control elements in the implementation of cost containment policies. Multicriteria Decision Analysis (MCDA) is increasingly used in health care to facilitate health care decision based on multiple objectives. Our objective was to develop a pilot MCDA tool for repeated use to support the value-based purchasing of generic medicines in the UAE. Methods: An international evidence framework was adapted to UAE in a multistakeholder workshop organized by Dubai Health Authority. After validating the relevance of nine criteria in the local jurisdiction, participants decided the ranking and weight of each criterion by anonymous voting. Results: The top four criteria focused on quality elements starting with real-world clinical or economic outcomes (with 19.8% weight), followed by the quality assurance of manufacturing (17.3%), then evidence on the equivalence with the original product (14.8%), and drug formulation and stability (12.3%). The pharmaceutical acquisition cost criteria ranked fifth with 9.4% weight. The bottom four criteria, including reliability of drug supply, macroeconomic benefit, pharmacovigilance and added value services related to the product had similar weights in the range of 5.5-7.7%. Conclusion: Policy-makers in Dubai put high emphasis of value-based health care by incentivizing manufacturers of off-patent pharmaceuticals to generate additional scientific evidence compared to the mandatory minimum and acknowledging efforts to improve quality standards. The MCDA tool is considered suitable to improve the transparency and consistency of decision making in UAE for off-patent pharmaceuticals, and subsequently for other health technologies.

Risk factors for hypocalcaemia after completion hemithyroidectomy in thyroid cancer.

BACKGROUND: Hypocalcaemia (HC) is the most common complication after thyroid surgery in differentiated thyroid cancer and leads to a prolongation of the hospital stay. While risk factors for HC after total thyroidectomy (TE) are well investigated, only few studies have been published about HC risk factors after completion of thyroidectomy. Our aim was to identify potential risk factors for HC after completion of TE and to compare these incidences with figures from primary total TE. MATERIALS AND METHODS: A retrospective cohort study was undertaken including patients undergoing completion of TE between 2002 and 2013 in our tertiary care centre. Patients with hypocalcaemia (group 1) after undergoing second surgery were compared to normocalcaemia patients (group 2) with respect to gender, age, type of thyroid cancer, time interval between surgeries, pre/postoperative calcium and parathyroid hormone (PTH) levels, clinical hypocalcaemia signs and calcium substitution (intravenous, oral). Hypocalcaemia was defined as <2.10 mmol/l, hypoparathyroidism as <15pg/ml. RESULTS: 34 (25 female, 9 male) patients were included. A total of 12 patients (33%) developed a hypocalcaemia (group 1). Three patients out of these also presented with hypoparathyroidism. One patient in each group showed clinical signs of hypocalcaemia. Calcium substitution was necessary in six cases in group 1 and in one case in group 2. There was a significant difference between the groups concerning postoperative PTH (25.1 vs 37.6 pg/ml) and calcium levels (1.87 vs 2.27 mmol/l) (p <0.05). Group comparison shows no significant relationships between all other parameters (age, gender, type of thyroid cancer and duration of interval between surgeries). Logistic regression analysis identified a low preoperative serum calcium level as the only dominant factor indicating postoperative hypocalcaemia. CONCLUSIONS: A hypocalcaemia rate of 33% (12/34) and a hypoparathyroidism rate of 9% (3/34) after completion of thyroidectomy in our cohort is comparable to primary total thyroidectomy. A low preoperative calcium level is a significant risk factor for postoperative hypocalcaemia after completion of thyroidectomy. The prediction of hypocalcaemia still remains difficult since it has multifactorial causes.

THREAT helps to identify epistaxis patients requiring blood transfusions.

OBJECTIVE: To analyze the characteristics of patients who needed a blood transfusion due to epistaxis-caused anemia and to define potential risk factors. DESIGN: Retrospective cohort study. SETTING: A total cohort of 591 epistaxis patients, prospectively included between March 2007 and April 2008 at the ENT department of the University Hospital of Zurich, was evaluated concerning the need for blood transfusions. METHODS: The clinical charts and medical histories of these patients were evaluated. MAIN OUTCOME MEASURES: Common parameters that increase the risk for severe anemia due to epistaxis. RESULTS: Twenty-two patients required blood transfusions due to their medical condition. 22.7% suffered from traumatic nosebleeds. Another 27.3% had a known medical condition with an increased bleeding tendency. These proportions were significantly higher than in the group of patients without need of blood transfusion. The odds ratio for receiving a blood transfusion was 14.0 in patients with hematologic disorders, 4.3 in traumatic epistaxis and 7.7 in posterior bleeders. The transfusion-dependent epistaxis patients suffered significantly more often from severe posterior nosebleeds with the need for a surgical therapeutic approach. CONCLUSIONS: Patients with severe nosebleeds either from the posterior part of the nose or with known hematologic disorders or traumatic epistaxis should be closely monitored by blood parameter analyses to evaluate the indication for hemotransfusion. The acronym THREAT (Trauma, Hematologic disorder, and REAr origin of bleeding → Transfusion) helps to remember and identify the factors associated with an increased risk of receiving blood transfusion.

18F-FDG-PET/CT for the assessment of the contralateral neck in patients with head and neck squamous cell carcinoma.

OBJECTIVES/HYPOTHESIS: The aim was to compare the value of 18-Fluoro-Deoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography (CT) regarding contralateral lymph node (LN) metastasis in the neck. STUDY DESIGN: Retrospective analysis of 61 patients staged by 18F-FDG-PET/CT. METHODS: Cytology/histology served as a reference standard. Further, metabolic midline invasion (MI) of the primary tumor and the presence of bilateral LN metastases were assessed. RESULTS: A true positive rate in the ipsilateral neck of 80% versus 65% in the contralateral neck was found (P = 0.067). Median-standardized uptake value (SUV)-max for suspicious LN ipsilaterally was 7.6 versus 5.8 contralaterally (P = 0.038). There was no positive correlation between metabolic MI and bilateral metastasis (P = 0.82). CONCLUSIONS: The rate of true positive detected LN by 18F-FDG-PET/CT is less on the contralateral neck side; therefore, all suspicious LNs should be verified by cytology. A high SUV in the contralateral neck suggests metastatic disease regardless of nodal size. Metabolic MI needs to be addressed carefully as it was not predictive for bilateral LN involvement. LEVEL OF EVIDENCE: 4.

Physiologic [18F]fluorodeoxyglucose uptake of floor of mouth muscles in PET/CT imaging: a problem of body position during FDG uptake?

OBJECTIVE: Assess the influence of 2 different patient positions during [18F]fluorodeoxyglucose (FDG) uptake phase on physiologic FDG accumulation of the floor of mouth (FOM) muscles. STUDY DESIGN: A prospective study design was used. METHODS: Two hundred prospectively enrolled patients were included in the study: (a) head and neck cancer (HNC) patients in supine or (b) sitting position, (c) patients with other malignant tumours in supine or (d) sitting position. An intra-individual analysis was done on patients (b) and (d) when such scans were available. Maximum standardized uptake values without correction and corrected for blood pool activity were assessed. RESULTS: The inter-individual analysis (sitting vs supine) revealed no significant differences (P = 0.17 and P = 0.56). The subgroup analysis on the patients with HNC (P = 0.56 and P = 0.15) and in patients with other malignancies (P = 0.14 and P = 0.08) revealed no significant difference; neither did the intra-individual analysis. CONCLUSIONS: The supine or sitting position during the uptake phase for FDG-positron emission tomography/computed tomography has no effect on the amount and distribution of physiologic FDG activity in the muscles of the FOM.

Contrast-enhanced ¹8F-FDG-PET/CT for the assessment of necrotic lymph node metastases.

BACKGROUND: Cystic lymph node metastasis (CLNM) is commonly found in human papillomavirus (HPV)-associated tonsillar squamous cell carcinoma (SCC). The aim of this study was to compare the accuracy in detecting cystic lymph node metastasis from tonsillar SCC between contrast-enhanced CT, ¹8F- fluorodeoxyglucose-positron emission tomography (FDG-PET), non-enhanced ¹8F-FDG-PET/CT, and contrast-enhanced ¹8F-FDG-PET/CT. METHODS: Thirty-four patients with a tonsillar SCC undergoing a pretreatment contrast-enhanced ¹8F-FDG-PET/CT followed by a neck dissection as a standard of reference were included. The contrast-enhanced CT part, the ¹8F-FDG-PET part, the non-enhanced ¹8F-FDG-PET/CT part, and the contrast-enhanced ¹8F-FDG-PET/CT were assessed separately for correct N classification and the differentiation of N0 versus N+. RESULTS.: Contrast-enhanced ¹8F-FDG-PET/CT, non-enhanced ¹8F-FDG-PET/CT, and contrast-enhanced CT are equally accurate for correct neck staging. Regarding pN0 versus pN+, contrast-enhanced CT and contrast-enhanced ¹8F-FDG-PET/CT are superior to non-enhanced ¹8F-FDG-PET/CT (p = .017). CONCLUSION: Contrast-enhanced CT and contrast-enhanced ¹8F-FDG-PET/CT perform equally and better than non-enhanced ¹8F-FDG-PET/CT in detecting CLNM in tonsillar SCC. Therefore, in patients scheduled for ¹8F-FDG-PET/CT, we strongly suggest performing a contrast-enhanced ¹8F-FDG-PET/CT, which is not routine in most centers.

18F-FET PET/CT in advanced head and neck squamous cell carcinoma: an intra-individual comparison with 18F-FDG PET/CT.

PURPOSE: To assess the diagnostic value of O-2-fluoro-18(F)-ethyl-L-tyrosine ((18)F-FET) positron emission tomography/computed tomography (PET/CT) for patients with advanced head and neck squamous cell carcinoma compared with 18F-fluoro-2-deoxy-D-glucose ((18)F-FDG) PET/CT at initial staging and following radiochemotherapy. PROCEDURES: Thirteen patients were prospectively enrolled; each of them underwent an (18)F-FDG PET/CT and (18)F-FET PET/CT before treatment. Ten of those were scanned 10 weeks after treatment. RESULTS: Sensitivity, specificity, and accuracy for (18)F-FDG PET/CT (primary and lymph node metastases) at initial staging were 89%, 50%, and 81%. For (18)F-FET PET/CT the numbers were 70%, 90%, and 74%. Sensitivity, specificity, and accuracy for (18)F-FDG PET/CT at follow-up were 71%, 65%, and 67%. For (18)F-FET PET/CT the numbers were 29%, 100%, and 83%. Additionally, (18)F-FDG PET/CT detected a higher number of second malignancies or distant metastases. CONCLUSIONS: (18)F-FET is no substitute for (18)F-FDG. Although it is more specific, too many malignant lesions are missed due to its lower sensitivity.