Medicolegal analysis of physical violence toward physicians in Egypt.

This study analyzed physical violence against physicians in Egypt from a medicolegal perspective. 88%, 42%, and 13.2% of participants were exposed to verbal, physical, and sexual violence. Concerning the tools of violence, 75.2% of attackers used their bodies. Blunt objects (29.5%), sharp instruments (7.6%), and firearm weapons (1.9%) were used. The commonest manners of attacks were pushing/pulling (44.8%), throwing objects (38.1%), and fists (30.5%). Stabbing (4.8%) and slashing (2.9%) with sharp instruments were also reported. Traumas were mainly directed towards upper limbs (43.8%), trunks (40%), and heads (28.6%). Considering immediate effects, simple injuries were reported that included contusions (22.9%), abrasions (16.2%), and cut wounds (1.9%). Serious injuries included firearm injuries (4.8%), internal organs injuries (3.8%), fractures (2.9%), and burns (1.9%). Most (90.5%) of injuries healed completely, whereas 7.6% and 1.9% left scars and residual infirmities, respectively. Only 14.3% of physicians proceeded to legal action. The current study reflects high aggression, which is disproportionate to legal actions taken by physicians. This medicolegal analysis could guide protective measures for healthcare providers in Egypt. In addition, a narrative review of studies from 15 countries pointed to violence against physicians as a worldwide problem that deserves future medicolegal analyses.

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.

The clinical & economic burden of treatment-resistant depression in the Gulf-Cooperation Council: The Kingdom of Saudi Arabia, Kuwait and the United Arab Emirates.

OBJECTIVE: The current analysis assessed the economic and clinical burden of treatment-Resistant Depression (TRD) imposed on the Kingdom of Saudi Arabia (KSA), Kuwait and United Arab Emirates (UAE) from the societal perspective. METHODS: A Microsoft Excel® based Markov model was developed to estimate the overall burden of disease imposed by TRD across KSA, Kuwait and UAE. Data for the models' adaptation were retrieved from literature and validated by country-specific key opinion leaders. The cycle length and time horizon used in the model were 4 weeks and 1 year, respectively. RESULTS: The study results estimated that at the end of 1-year time horizon, overall burden imposed by TRD was 3994, 982 and 670 million USD in KSA, Kuwait, and UAE, respectively. This can be attributed to the high cost incurred due to non-responsive health state (ranging from 44% to 47%). The productivity loss was either the greatest or second greatest component of TRD's burden in the countries of interest (ranging from 32% to 43%). CONCLUSIONS: TRD represents a large clinical and economic burden on both individual patients and society. Hence, noval and innovative treatments are especially required for the management of TRD patients.

Economic evaluation of cladribine tablets in high disease activity (HDA) relapsing multiple sclerosis (RMS) patients in Lebanon.

BACKGROUND: Cladribine tablets are a newly launched short course oral treatment approved for high disease activity (HDA) relapsing multiple sclerosis (RMS). The current analysis assessed the cost-utility and budgetary impact of introducing cladribine tablets in HDA-RMS patients compared with other HDA-RMS therapies in Lebanon. METHODS: The global cost-utility and budget impact models were adapted from Lebanese National Social Security Fund (NSSF) perspective. The data for the models' adaptation were retrieved from the literature and validated by Lebanese experts. The comparators considered in the cost-utility model were alemtuzumab, fingolimod, and natalizumab while budget impact analysis additionally considered dimethyl fumarate. A sensitivity analysis was also performed to assess the uncertainty in the analysis. RESULTS: The cost-utility results showed that cladribine tablets are an economically dominant therapeutic strategy (i.e., less costly and better quality-adjusted life year [QALY]) compared to all comparators. The cost saving was driven by drug acquisition, administration, and monitoring costs; while incremental QALY gain was driven by differences in delayed Expanded Disability Status Scale progression. Sensitivity analysis showed that cladribine tablets have a high probability (99.3-100%) of being dominant at a threshold of 22,000 United States Dollars (approximately three times of gross domestic product) per QALY gained against different comparators. The budget impact analysis showed that the introduction of cladribine tablets would result in 5.0% to 21.5% savings in the overall budget over a period of five years. CONCLUSIONS: Cladribine tablets are a cost-effective and a budget-saving treatment option for the treatment of HDA-RMS patients in Lebanon from the NSSF perspective.

Economic Evaluation of Cladribine Tablets in Patients With High Disease Activity-Relapsing-Remitting Multiple Sclerosis in the Kingdom of Saudi Arabia.

OBJECTIVE: Cladribine tablets are the first short-course oral treatment approved for high disease activity relapsing-remitting multiple sclerosis (HDA-RRMS) across various countries. This analysis assessed the cost-effectiveness of introducing cladribine tablets as a treatment option for patients with high disease activity compared with other HDA-RRMS therapies in the Kingdom of Saudi Arabia (KSA). METHODS: The cost-effectiveness model was adapted from the KSA payer's perspective. Data for the model's adaptation were retrieved from the literature and validated by key opinion leaders. The comparators considered in the model were alemtuzumab, dimethyl fumarate, fingolimod, interferon beta-1a (subcutaneous and intramuscular) and beta-1b, natalizumab, and teriflunomide. A sensitivity analysis was also performed to assess the robustness of the analysis. RESULTS: The cost-effectiveness results showed cladribine tablets as the dominant strategy (ie, less costly and more effective) versus all the comparators. The incremental cost and quality-adjusted life-years gained were largely driven by drug acquisition cost and delayed expanded disability status scale progression, respectively. Cladribine tablets showed an 81% to 100% probability of being cost-effective at a threshold of Saudi Riyal 225 326 per quality-adjusted life-years gained against different comparators. CONCLUSIONS: Cladribine tablets are a dominant treatment option for patients with HDA-RRMS from the payer perspective in the KSA.

Clinical and economic burden of nonalcoholic steatohepatitis in Saudi Arabia, United Arab Emirates and Kuwait.

BACKGROUND AND AIMS: The Middle East (ME) has a high prevalence of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), driven by obesity and type-2 diabetes mellitus (T2DM). Studies in Saudi Arabia (KSA) and United Arab Emirates (UAE) predict an escalating impact of NAFLD/NASH, particularly advanced fibrosis due to NASH (AF-NASH), increasing cases of cirrhosis, liver cancer and death. The scale of this burden in other ME countries is unknown with no reports of NAFLD/NASH healthcare resource utilization (HCRU) or costs. We estimated the clinical and economic burden of NAFLD/NASH in KSA, UAE and Kuwait. METHODS: Markov models populated with country-specific obesity and T2DM prevalence data estimated numbers and progression of NAFLD/NASH patients from 2018 to 2030. Model inputs, assumptions and outputs were collected from literature, national statistics, and expert consensus. RESULTS: Over 13 years, the KSA model estimated cases increasing as follows: patients with fibrosis F0-3 doubled to 2.5 m, compensated and decompensated cirrhosis and hepatocellular carcinoma trebled to 212,000; liver failure or transplant patients increased four-fold to 4,086 and liver-related death escalated from < 10,000 to > 200,000. Similar trends occurred in UAE and Kuwait. Discounted lifetime costs of NASH standard-care increased totaling USD40.41 bn, 1.59 bn and 6.36 bn in KSA, UAE (Emiratis only) and Kuwait, respectively. NASH-related costs in 2019 comprised, respectively, 5.83%, 5.80% and 7.66% of national healthcare spending. CONCLUSIONS: NASH, especially AF-NASH, should be considered a higher priority in ME Public Health policy. Our analyses should inform health policy makers to mitigate the enormity of this escalating regional burden.

Translation, cultural adaptation and psychometric validation of the SF-6D measure of health-related quality of life for use in Arabic-Speaking countries.

BACKGROUND: The SF-6D is a generic, six-dimensional health-related quality of life (HRQoL) measure derived from a selection of items from the SF-36. OBJECTIVES: To translate, culturally adapt and validate the SF-6D for use in Arabic-speaking countries. METHODS: The International Quality of Life Assessment (IQOLA) methodology was followed. Two forward translations, one consensus and one backward translation were undertaken. Difficulties encountered were categorized as grammatical, idiomatic, semantic/conceptual, and cultural. The content validity of the final version was tested and Cronbach's alpha test of internal consistency was used for assessing reliability. Confirmatory factor analysis (CFA), was also used to assess construct validity and to test a pre-specified relationship of observed measures. RESULTS: Minor changes were made to the forward translation to improve cultural appropriateness. The Backward translation did not reveal major problems and equivalence to the original was confirmed following committee review. A total of 470 participants from Jordan, Egypt, UAE, Qatar and Palestine completed the translated SF-6D. All the incremental indices values are ≥0.90 and close to 1. Item loading values ranged from 0.52 to 0.87. The measurement model weight for those with chronic health conditions ranged from 0.68 to 0.91, and from 0.42 to 0.73 for those without. The percentage of variation in self-reported health state was about 55%. The measurement weight of SF-6D on self-reported health state among chronic responders was 0.87 while among responders reporting no chronic disease was 0.61. The t-value for the difference in measurement weight was -8.93 (p ≤ 0.01). CONCLUSION: Arabic translation and cultural adaptation of SF-6D has resulted in an acceptable and culturally-adapted version that can be used in Arabic-speaking countries. Reliability and validity have been confirmed as well as ability to assess the difference in quality of life between patients with chronic health conditions and healthy individuals.

Pharmaceutical Policy Reforms to Regulate Drug Prices in the Asia Pacific Region: The Case of Australia, China, India, Malaysia, New Zealand, and South Korea.

Medicine price directly affects affordability and access to medicines particularly in countries where a major portion of pharmaceutical spending is through out-of-pocket payment, such as in the Asia Pacific region. We have undertaken a detailed appraisal of the pharmaceutical policy reforms to regulate drug prices in 3 developed (Australia, New Zealand, and South Korea) and 3 emerging (China, India, and Malaysia) economies of the Asia Pacific region. Despite continuous efforts by the authorities in adopting a wide range of reformatory pharmaceutical pricing policies to ensure affordability of medicines, these policies may not be optimal where drug prices were not lowered as expected (eg, in Korea). On the contrary, considerable price reductions of various pharmaceuticals have been observed in New Zealand and India because of the reform in pharmaceutical pricing policy. This review of pharmaceutical pricing reforms reinforces the need for constant monitoring by policy makers in Asia Pacific countries to regulate drug prices and to undertake reform in pharmaceutical pricing policies when necessary to ensure affordability and access to medicines.

The Impact of a Pricing Policy Change on Retail Prices of Medicines in Egypt.

OBJECTIVES: To describe the products with price changes and assess the impact of price changes on the products' price and affordability within the context of the Egyptian market. METHODS: A descriptive pre-post observational study was conducted. We selected March through June 2013 as the post-change observation period. A matching pre-change observation period, one year earlier, was selected to be consistent with potential seasonal variation in product use. RESULTS: It was found that 65.7% of the products with price changes were low-priced generic products. The overall average percent change in price was 24.7%. Before decree #499 implementation, the average affordability of the low-, medium-, and high-priced products was 0.25 days' wage, 2 days' wage, and more than 100 days' wage, respectively. After the implementation, the cost increase for the low- and medium-priced products was less than 0.1 days' wage, whereas the high-priced products' cost decreased by 11 days' wage. CONCLUSIONS: The policy change resulted in both price decreases and increases without substantive implications on affordability.