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.

Cost-effectiveness analysis of upadacitinib as a treatment option for patients with rheumatoid arthritis in the Kingdom of Saudi Arabia.

AIM: To evaluate cost-effectiveness of upadacitinib (targeted synthetic-disease modifying anti-rheumatic drug [ts-DMARD]) as first-line (1 L) treatment versus current treatment among patients with rheumatoid arthritis (RA) in the Kingdom of Saudi Arabia (KSA), who had an inadequate response to prior conventional-synthetic (csDMARDs) and/or biologic-DMARDs (bDMARDs). METHODS: This Excel-based model included patients with moderate (Disease Activity Score [DAS28]: >3.2 to ≤5.1) or severe RA (DAS28 > 5.1). Cost-effectiveness of current treatment (1 L: adalimumab-originator/biosimilar; second-line (2 L): other bDMARDs/tofacitinib) was compared against a new treatment involving two scenarios (1 L: upadacitinib, 2 L: adalimumab-biosimilar [scenario-1]/adalimumab-originator [scenario-2]) for a 10-year time-horizon from societal perspective. Model outcomes included direct and indirect costs, quality-adjusted life-years (QALYs), hospitalization days, number of orthopedic surgeries, and incremental cost-utility ratio (ICUR) per QALY. RESULTS: With the current pathway, estimated total societal costs for 100 RA patients over 10-year period were Saudi Riyal (SAR) 50,450,354 (United States dollars [USD] 13,453,428) (moderate RA) and SAR50,013,945 (USD13,337,052) (severe RA). New pathway (scenario-1) showed that in patients with moderate-to-severe RA, upadacitinib led to higher QALY gain (+8.99 and +15.63) at lower societal cost (cost difference: -SAR2,023,522 [-USD539,606] and -SAR3,373,029 [-USD899,474], respectively). Thus, as 1 L, upadacitinib projects "dominant" ICUR per QALY over current pathway. Moreover, in alternate pathway (scenario-2), upadacitinib also projects "dominant" ICUR per QALY for patient with severe RA (QALY gain: +15.63; cost difference: -SAR 164,536 [-USD43,876]). However, moderate RA was associated with additional cost of SAR1,255,696 (USD334,852) for improved QALY (+8.99) over current pathway (ICUR per QALY: SAR139,742 [USD37,264]). Both scenarios resulted in reduced hospitalization days (scenario-1: -14.83 days; scenario-2: -11.41 days) and number of orthopedic surgeries (scenario-1: -8.36; scenario-2: -6.54) for moderate-to-severe RA over the current treatment pathway. CONCLUSION: Upadacitinib as 1 L treatment in moderate-to-severe RA can considerably reduce healthcare resource burden in KSA, majorly due to reduced drug administration/monitoring/hospitalization/surgical and indirect costs.

An Institutional Guide for Formulary Decisions of Biosimilars.

Biologics have changed the landscape for the management of many debilitating chronic diseases but account for a significant expenditure of medications globally. Fortunately, advances in technology paved the way for the introduction of biosimilars, which are highly similar to the originator biologics. In the quest to reduce the budget impact of biologics, organizations have begun to adopt biosimilars. Institutions evaluating biosimilars for inclusion in the hospital formulary must make informed formulary decisions by conducting a thorough review of key elements for evaluation of biosimilars and address the multidimensional aspects during the selection process of different biosimilar products. Therefore, we aim to present an institutional guide of these elements to inform formulary decisions. These key elements include biosimilar evaluation for formulary addition; regulatory approval; substitution, interchangeability, and switching; extrapolation; product characteristics, manufacturing, and supply chain issues; pharmacoeconomic evaluations; traceability, nomenclature, and coding; education; and pharmacovigilance.

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.

Digital Biomarker-Based Interventions: Systematic Review of Systematic Reviews.

BACKGROUND: The introduction of new medical technologies such as sensors has accelerated the process of collecting patient data for relevant clinical decisions, which has led to the introduction of a new technology known as digital biomarkers. OBJECTIVE: This study aims to assess the methodological quality and quality of evidence from meta-analyses of digital biomarker-based interventions. METHODS: This study follows the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline for reporting systematic reviews, including original English publications of systematic reviews reporting meta-analyses of clinical outcomes (efficacy and safety endpoints) of digital biomarker-based interventions compared with alternative interventions without digital biomarkers. Imaging or other technologies that do not measure objective physiological or behavioral data were excluded from this study. A literature search of PubMed and the Cochrane Library was conducted, limited to 2019-2020. The quality of the methodology and evidence synthesis of the meta-analyses were assessed using AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews 2) and GRADE (Grading of Recommendations, Assessment, Development, and Evaluations), respectively. This study was funded by the National Research, Development and Innovation Fund of Hungary. RESULTS: A total of 25 studies with 91 reported outcomes were included in the final analysis; 1 (4%), 1 (4%), and 23 (92%) studies had high, low, and critically low methodologic quality, respectively. As many as 6 clinical outcomes (7%) had high-quality evidence and 80 outcomes (88%) had moderate-quality evidence; 5 outcomes (5%) were rated with a low level of certainty, mainly due to risk of bias (85/91, 93%), inconsistency (27/91, 30%), and imprecision (27/91, 30%). There is high-quality evidence of improvements in mortality, transplant risk, cardiac arrhythmia detection, and stroke incidence with cardiac devices, albeit with low reporting quality. High-quality reviews of pedometers reported moderate-quality evidence, including effects on physical activity and BMI. No reports with high-quality evidence and high methodological quality were found. CONCLUSIONS: Researchers in this field should consider the AMSTAR-2 criteria and GRADE to produce high-quality studies in the future. In addition, patients, clinicians, and policymakers are advised to consider the results of this study before making clinical decisions regarding digital biomarkers to be informed of the degree of certainty of the various interventions investigated in this study. The results of this study should be considered with its limitations, such as the narrow time frame. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/28204.

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.

Real-World Impact of Switching From Insulin Glargine (Lantus®) to Basaglar® and Potential Cost Saving in a Large Public Healthcare System in Saudi Arabia.

Background: The advent of Basaglar®, which is a biosimilar insulin glargine formulation for Lantus® has brought hope that it will result in similar outcomes and lower costs. However, some health practitioners raised some concerns about the therapeutic equivalence of this new biosimilar. Therefore, we aimed to examine the clinical and financial impact of switching from Lantus® to Basaglar®. Methods: This was a single-center retrospective chart review study of adult patients (e.g., ≥18 years) with diabetes mellitus (DM) who were treated with insulin glargine (Lantus®) for at least 12 months and then switched to Basaglar® for another 12 months. The potential cost savings for the years 2018 to 2021 and the cost avoidance for 2022 were estimated using different conversion ratios between the two insulin glargine products (Basaglar® and Lantus®) and acquisition prices. Results: One-hundred patients with DM who were previously treated with Lantus® and switched to Basaglar® were retrospectively recruited. About two-thirds of the patients (68%) had type 2 DM, and the male and female patients were equally represented. The mean glycated hemoglobin (A1C) at baseline was 9, and the mean difference in the A1C levels before and after switching to Basaglar® was not significant (0.18, p-value = 0.503, 95% CI [-0.36-0.72]). Although the difference in the total daily insulin units between Lantus® and Basaglar® was not significant, the difference was leaning toward statistical significance despite the small sample size (-1.88, P-value = 0.25, 95% CI [-5.15-1.38]). Switching from Lantus® to Basaglar® could have led to significant cost savings that would range from approximately 1.77 to 23.7 million United States Dollars (USD) for the years 2018 to 2021 assuming an equal conversion ratio. However, those cost savings might not be realized if the switching to Basaglar® required higher daily insulin units, and the difference in the public tender acquisition price between Lantus® and Basaglar® is less than 15%. Conclusion: Basaglar® and potentially other biosimilar insulin glargine products can lead to significant cost savings without compromising the quality of care. However, their acquisition prices should be discounted.

Disease-Related Costs Published in The Middle East and North Africa Region: Systematic Review and Analysis of Transferability.

BACKGROUND: In the Middle East and North Africa (MENA) the scarcity of local cost data is a key barrier to conducting health economic evaluations. We systematically reviewed reports of disease-related costs from MENA and analysed their transferability within the region. METHODS: We searched PubMed and included full text English papers that reported disease-related costs from the local populations of Algeria, Bahrain, Egypt, Iraq, Jordan, Saudi Arabia, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Qatar, Syria, Tunisia, United Arab Emirates and Yemen between 1995 and 2019. Screening, study selection and data extraction were done in duplicate. Study-related variables, costing methods, all costs and their characteristics were extracted and analysed via descriptive methods. From multi-country studies of MENA employing homogenous costing methods, we estimated the ratio (cost transfer coefficient) between the relative differences in direct medical costs and macroeconomic indicators via robust regression. We predicted each cost via the estimated cost transfer formula and evaluated prediction error between true and predicted (transferred) costs. RESULTS: The search yielded 1646 records, 206 full text papers and 3525 costs from 84 diagnoses. Transferability was analysed involving 144 direct medical costs from eight multi-country studies. Adjusting the average of available foreign costs by 0.28 times the relative difference in GDP per capita provided the most accurate estimates. The correlation between true and predicted costs was 0.96; 68% of predicted costs fell in the true ± 50% range. Predictions were more accurate for costs from studies that involved the largest number of countries, for countries outside the Gulf region and for drug costs versus unit or disease costs. CONCLUSION: The estimated cost transfer formula allows the prediction of missing costs in MENA if only GDP per capita is available for adjustment to the local setting. Input costs for the formula should be collected from multiple sources and match the decision situation.

In the Middle East and North Africa (MENA) scarce local cost data hinder health economic evaluations. This systematic review summarized disease-related costs from 17 countries (Algeria, Bahrain, Egypt, Iraq, Jordan, Saudi Arabia, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Qatar, Syria, Tunisia, United Arab Emirates and Yemen). Eight studies applied the same costing method across multiple countries. We used these data to estimate a formula for transferring costs between countries. We assumed that costs vary proportionally with gross domestic product per capita (GDP). Most accurate cost predictions were provided when relative cost differences were set to 0.28-times the relative differences in GDP per capita. The correlation between transferred and true costs was very high. Still, only 68% of transferred costs fell in the true ± 50% range. Cost estimates were more accurate if costs were transferred from multiple countries. Also, estimates were more accurate for countries outside the Gulf region and for drug costs when compared to unit- or disease costs.

Demographic Characteristics and Status of Vaccinated Individuals with a History of COVID-19 Infection Pre- or Post-Vaccination: A Descriptive Study of a Nationally Representative Sample in Saudi Arabia.

BACKGROUND: Saudi Arabia expedited the approval of some COVID-19 vaccines and launched mass vaccination campaigns. The aim of this study was to describe the demographics of vaccinated COVID-19 cases and compare the mortality rates of COVID-19 cases who were infected post-vaccination in Saudi Arabia. METHODS: This was a retrospective cohort study. We retrieved data for COVID-19 cases who were infected pre- or post-vaccination and had received at least one injection of the Oxford-AstraZeneca or Pfizer-BioNTech vaccine from 4 December 2020 to 15 October 2021. RESULTS: The number of patients who were infected and had received at least one dose of a COVID-19 vaccine was 281,744. Approximately 45% of subjects were infected post-vaccination, and 75% of subjects had received the Pfizer-BioNTech vaccine. Only 0.342% of the patients who were infected post-vaccination died, and 447 patients were admitted to ICUs. Most of the patients who were infected with COVID-19 post-vaccination and were admitted to ICUs (69.84%) had received only one dose of the vaccine (p < 0.0001). The mean time to infection for patients who had received one and two doses of the Oxford-AstraZeneca vaccine were 27 and 8 days longer than their counterparts who had received one and two doses of Pfizer-BioNTech vaccine, respectively. No difference in the odds of mortality between the Pfizer-BioNTech and Oxford-AstraZeneca vaccines was found (OR = 1.121, 95% CI = [0.907-1.386], p-value = 0.291). Patients who had received two doses of the vaccine had significantly lower odds of mortality compared to those who had received one dose (p < 0.0001). CONCLUSIONS: Vaccines are vital in combating the COVID-19 pandemic. The results of this study show no difference between the Pfizer-BioNTech and Oxford-AstraZeneca vaccines in the rate of mortality. However, the number of vaccine doses was significantly associated with a lower risk of mortality. Future studies should examine the effectiveness of different COVID-19 vaccines using real-world data and more robust designs.

Cost Consequence Analysis of the Management of Hyperkalemia by Patiromer and Optimization of Renin-Angiotensin-Aldosterone System Inhibitors Therapy in Chronic Kidney Disease Patients in Saudi Arabia.

Renin-angiotensin-aldosterone system inhibitors (RAASi) have been shown to improve outcomes in chronic kidney disease (CKD) patients but are associated with an increased risk of hyperkalemia in this vulnerable population. Hyperkalemia often leads to patients' downtitrating or discontinuing RAASi which can result in sub-optimal health outcomes. The objective is to evaluate the cost and health benefits of maintaining normokalemia using patiromer, an oral potassium binder while optimizing RAASi therapy in CKD patients in the Kingdom of Saudi Arabia. The medium-to long-term costs and health outcomes of patients with CKD stage 3-4 and raised serum potassium levels (≥5.5 mmol/L) at baseline were estimated, from a Saudi Arabia payer perspective, using a Markov state-transition model simulating the natural progression of CKD depending on patients' serum potassium level and usage of RAASi at different dosages. The analysis demonstrated that appropriate management of hyperkalemia, enabling optimization of RAASi, leads to cost and health benefits. The cost of patiromer is offset by 68% due to a reduction in management costs associated with CKD progression, hyperkalemia-related hospitalization, and cardiovascular (CV) events. Over a 10-year time horizon, a pool of 300 patients treated with patiromer experience increased life-expectancy [+3.78 life-years (LYs)] and slower disease progression, with decreased time spent in end-stage renal disease (-9.59 LYs). Patiromer may deliver value to both CKD patients and payers in Saudi Arabia, leading to better health outcomes for the former and reduced cost of management of CKD progression and CV events at low additional costs for the latter.

Pharmacy and Therapeutics Committee Preparedness Plan for COVID-19.

As the Pharmacy and Therapeutics (P&T) committee acts as an advisory committee on therapeutic options, it is important during pandemics, such as the current Coronavirus disease 2019 pandemic, to quickly search the evidence, be able to select the most appropriate therapies despite the limited evidence, and make appropriate decisions related to which drugs to procure and stock. Potential therapies and recommendations to the P&T committee at a large healthcare institution as means of a preparedness plan are reviewed here.