Budget impact of introducing oral semaglutide to the public healthcare benefit package in Saudi Arabia.

BACKGROUND: The Kingdom of Saudi Arabia (KSA) has embarked on a Health Sector Transformation Program as part of the Kingdom's Vision 2030 initiatives with the facilitation of access to healthcare services for the millions in KSA with diabetes an essential part of the Program. Decision-making tools, such as budget impact models, are required to consider the addition of new medications like oral semaglutide that have multifaceted health benefits and address barriers related to therapeutic inertia to reduce diabetes-related complications. OBJECTIVE: To determine the financial impact of the introduction of oral semaglutide as a treatment option for people with type 2 diabetes mellitus (T2DM) in KSA. METHODS: From the public payer's perspective, the budget impact model estimates the costs before and after the introduction of oral semaglutide over a 5-year time horizon. The budget impact of introducing oral semaglutide (primary comparator) compared with three different classes of diabetes medicines: glucagon-like peptide-1 receptor agonists (GLP-1), sodium-glucose transport protein 2 inhibitors (SGLT 2i) and dipeptidyl peptidase 4 inhibitors (DDP-4i) have been calculated based on the projected market shares. The model includes the cost of care through the incorporation of health outcomes that have an impact on the national payer's budget in Saudi Riyals (SAR). RESULTS: The budget impact over the five-year time horizon indicates a medication cost increase (17,424,788 SAR), and cost offsets which include a difference in diabetes management costs (-3,625,287 SAR), CV complications costs (-810,733 SAR) and weight loss savings of 453,936 SAR. The cumulative total cost difference is 12,427,858 SAR (0.66%). CONCLUSION: The introduction of oral semaglutide 14 mg as a second-line treatment option after metformin is indicated as budget-neutral to slightly budget-inflating for the public pharmaceutical formulary of KSA. The price difference is offset by positive health outcomes and costs. This conclusion was confirmed through a probabilistic sensitivity analysis.

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.

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.

Superinfection rate among the patients treated with carbapenem versus piperacillin/tazobactam: Retrospective observational study.

BACKGROUND: Superinfection is a new isolate pathogen after 48 h of antibiotic treatment or within one week of treatment discontinuation. In many studies carbapenem and piperacillin-tazobactam were associated with high risk of superinfection. AIM: To evaluate the rate of superinfections during carbapenem and piperacillin/tazobactam treatment. Also, to identify risk factors for superinfections. METHODS: A Retrospective observational study was conducted in King Abdulaziz Medical City. Approval from the institutional Review Board was obtained. The study included all adult patient treated with carbapenem or piperacillin/tazobactam for more than 72 h. Univariate and multivariate analysis was conducted to compare piperacillin/tazobactam versus carbapenems and to identify the associated risk factor to develop superinfection. FINDING: 507 patients were included in this study. The mean age of the patients was 61 years ± 19.33. Of these, 278 received carbapenems and 229 received piperacillin/tazobactam. In univariate analysis superinfections were significantly higher with carbapenems compared with piperacillin-tazobactam (28.77% versus 20.96%; P value = 0.044). After adjustment of cofounders in multivariate analysis, presence of tracheostomy, endotracheal ventilation, foley catheter and duration of antibiotic were associated with higher risk to developed superinfection adjusted odd ratio (aOR) 3.23 (95% CI,1.39-7.52) P < 0.01, aOR 2.556 (95% CI,1.30-5.02) P < 0.01, aOR 2.20 (95% CI,1.35-3.61) P < 0.001, aOR 1.051(95% CI,1.02-1.08) P < 0.001 respectively, but not carbapenems use aOR 1.052 (95% CI,0.657-1.685). CONCLUSIONS: The use of carbapenems were not associated with higher risk to developed superinfection. The most important risk factors associated with superinfection were presence of tracheostomy, endotracheal mechanical ventilation, Foley catheter and the duration of antibiotics.

Assessment of safety and effectiveness of oral multiple sclerosis medication.

OBJECTIVES: To assess the effectiveness and safety profile of the new disease modifying drugs (fingolimod, teriflunomide, and dimethyl fumarate) at a local hospital in Riyadh, Saudi Arabia. METHODS: This is a retrospective cohort, where institutional review board approval was granted in December 2015. The study was conducted at King Abdulaziz Medical City Research Center, Riyadh, Saudi Arabia. Demographic variables (age, gender, disease onset, and duration on medication), clinical variables (medication side effects and radiological findings), in addition to relapse frequency per year was collected. RESULTS: Fifty-seven patients' records were retrieved from the pharmacy and included in the analysis. Eight patients were on teriflunomide, 5 patients on dimethyl fumarate and 44 patients on fingolimod were enrolled. The patients' average age was 32.5 years with female gender representing 63% the study population. Annual relapse rates were 0.24, 0.34, and 0.5 per patient per year for those taking fingolimod, dimethyl fumarate, and teriflunomide, correspondingly, lymphopenia (91.4%), neutropenia (23%), and bradycardia (16%) were the most reported side effects for fingolimod therapy. CONCLUSION: The study results were able to capture the effectiveness rate for the targeted treatment in the studied population, with the frequency of incidence of side effects. However, as these results cannot be generalized for the entire Saudi population.

Drug resistant tuberculosis in Saudi Arabia: an analysis of surveillance data 2014-2015.

Background: There is limited data that investigates the national rates of drug-resistant tuberculosis (TB) in Saudi Arabia.This study aimed to estimate the rates of multi-drug-resistant tuberculosis (MDR-TB), rifampicin-resistant tuberculosis (RR-TB), and monoresistance (MR) in Saudi Arabia. Methods: A retrospective cohort study was conducted on all TB cases reported to the National TB Control and Prevention Program (NTCPP) registry at the Saudi Ministry of Health between January 1, 2014 and December 31, 2015. A total of 2098 TB patients with positive TB cultures were included in the study. Subgroup analyses and multivariate binary logistic regression models were performed with IBM SPSS 23.0. Results: Of the total TB cases, 4.4% (95% CI: 3.59%-5.40%) were found to have MDR-TB. The rates of MR were 3.8% (95% CI: 2.99%-4.67%) for ethambutol, 5.4% (95% CI: 4.50%-6.49%) for pyrazinamide, 10.2% (95% CI: 5.89%-11.52%) for isoniazid, 11% (95% CI: 9.70%-12.43%) for streptomycin, and 5.9% (95% CI: 4.90%-6.96%) for rifampicin. The high rates of MDR and RR-TB were found among the younger age group, female gender, and those who had a previous history of TB. We also discovered that renal failure tends to increase the risk of rifampicin resistance. Conclusions: National TB data in Saudi Arabia shows that the rate of MDR-TB was similar to the global rate reported by the World Health Organization (WHO). It is a relatively high rate as compared to Western countries. The proportion of MDR/RR-TB patients tends to be higher in the younger age group, female gender, and in patients with a previous history of TB treatment. Effective strategies for prevention of all multi-drug-resistant TB cases are warranted.

Assessment and comparison of CHADS2, CHA2DS2-VASc, and HAS-BLED scores in patients with atrial fibrillation in Saudi Arabia.

AIMS: No previous reports on the utilization of CHADS2, CHA2DS2-VASc, and HAS-BLED scores in atrial fibrillation (AF) patients in Saudi Arabia have been identified in the literature. The main objectives of this study were to assess and compare the distribution of CHADS2, CHA2DS2-VASc, and HAS-BLED scores and to identify the most common risk factors for stroke and bleeding among AF patients attending clinical pharmacists managed anticoagulation clinic. SETTINGS AND DESIGN: This cross-sectional study was conducted over 2 months period at clinical pharmacists managed anticoagulation clinic. METHODS: CHADS2, CHA2DS2-VASc, and HAS-BLED scores were calculated and compared for all eligible patients. RESULTS: Two hundred and sixty-four patients with AF were included in the analysis. The number of patients at low risk for stroke was found to be 14 (5.3%) using CHADS2 and only 4 (1.5%) using CHA2DS2-VASc. On the other hand, 64 patients (24.2%) were found at moderate risk for stroke using CHADS2 compared with 17 patients (6.4%) using CHA2DS2-VASc. Most of the patients were found to be at high risk for stroke using either the CHADS2 (70.5%) and CHA2DS2-VASc (92%). The study also revealed that most of the patients were at moderate (63.3%) to high (27.7%) risk of bleeding. CONCLUSIONS: The results of this study show that the percentage of patients at high risk for stroke and bleeding is very high. The study revealed that this could be attributed to the high prevalence of modifiable risk factors for stroke and for bleeding in Saudi patients with AF.