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Quentin M Anstee,1,2 Kate Hallsworth,1,2 Niall Lynch,3 Adrien Hauvespre,4 Eid Mansour,5 Sam Kozma,5 Juliana Bottomley,6 Gary Milligan,7 James Piercy,8 Victoria Higgins9 1Translational & Clinical Research Institute, Faculty of Medical Sciences, University of Newcastle, Newcastle Upon Tyne, UK; 2Liver Unit, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; 3Global Value and Access, Gilead Sciences, Hayes, Uxbridge, UK; 4Market Access and Reimbursement, Gilead Sciences, Hayes, Uxbridge, UK; 5Pricing and Market Access (Middle East), Gilead Sciences, Dubai, United Arab Emirates; 6Pricing and Market Access, Gilead Sciences, Hayes, Uxbridge, UK; 7Statistics Department, Adelphi Real World, Bollington, UK; 8Scientific Franchise, Adelphi Real World, Bollington, UK; 9Scientific and NASH Franchise, Adelphi Real World, Bollington, UKCorrespondence: Victoria Higgins, Adelphi Real World, Adelphi Mill, Grimshaw Lane, Bollington, SK10 5JB, UK, Tel +44 1625 577233, Email victoria.higgins@adelphigroup.comObjective: Stratifying disease severity in patients with non-alcoholic steatohepatitis (NASH) is essential for appropriate treatment and long-term management. Liver biopsy is the reference standard for fibrosis severity in NASH, but less invasive methods are used, eg, Fibrosis-4 Index (FIB-4) and vibration-controlled transient elastography (VCTE), for which reference thresholds for no/early fibrosis and advanced fibrosis are available. We compared subjective physician assessment of NASH fibrosis versus reference thresholds to understand classification in a real-world setting.Methods: Data were drawn from Adelphi Real World NASH Disease Specific ProgrammeTM conducted in France, Germany, Italy, Spain and UK in 2018. Physicians (diabetologists, gastroenterologists, hepatologists) completed questionnaires for five consecutive NASH patients presenting for routine care. Physician-stated fibrosis score (PSFS) based on available information was compared with clinically defined reference fibrosis stage (CRFS) determined retrospectively using VCTE and FIB-4 data and eight reference thresholds.Results: One thousand two hundred and eleven patients had VCTE (n = 1115) and/or FIB-4 (n = 524). Depending on thresholds, physicians underestimated severity in 16– 33% (FIB-4) and 27– 50% of patients (VCTE). Using VCTE ≥ 12.2, diabetologists, gastroenterologists and hepatologists underestimated disease severity in 35%, 32%, and 27% of patients, respectively, and overestimated fibrosis in 3%, 4%, and 9%, respectively (p = 0.0083 across specialties). Hepatologists and gastroenterologists had higher liver biopsy rates than diabetologists (52%, 56%, 47%, respectively).Conclusion: PSFS did not consistently align with CRFS in this NASH real-world setting. Underestimation was more common than overestimation, potentially leading to undertreatment of patients with advanced fibrosis. More guidance on interpreting test results when classifying fibrosis is needed, thereby improving management of NASH.Keywords: fibrosis staging, non-alcoholic steatohepatitis, clinically derived reference fibrosis score, physician-stated fibrosis score, real-world evidence

Coronavirus disease 2019 (COVID-19) has spread rapidly worldwide. Saudi Arabia was significantly impacted by COVID-19. In March 2021, 381,000 cases were reported with 6539 deaths. This study attempts to quantify the impact of remdesivir on healthcare costs in Saudi Arabia, in terms of intensive care unit admissions, mechanical ventilation, and death prevention.A forecasting model was designed to estimate the impact of remdesivir on the capacity of intensive care units and healthcare costs with patients requiring low flow oxygen therapy. The forecasting model was applied in the Saudi context with a 20-week projection between 1 February and 14 June, 2021. Model inputs were collected from published global and Saudi literature, available forecasting resources, and expert opinions. Three scenarios were assumed: the effective pandemic infection rate (Rt) remains at 1, the Rt increases up to 1.2, and the Rt declines from 1 to 0.8 over the study period.The model estimated that the use of remdesivir in hospitalized patients, in the optimistic and pessimistic scenarios, could prevent between 1520 and 3549 patient transfers to intensive care units and mechanical ventilation, prevent between 815 and 1582 deaths, and make potential cost savings between $US154 million and $US377 million owing to the reduction in intensive care unit capacity, respectively.The treatment with remdesivir may improve patient outcomes and reduce the burden on healthcare resources during this pandemic.

Objectives Hepatitis B virus (HBV) infection remains a worldwide public health problem. The last major review of the HBV care pathway in the Middle East was published in 2011. This article aims to assess the current situation of the HBV care pathway in Jordan, identify gaps and barriers and recommend initiatives that could be taken to improve disease management across all stages of the care pathway. Methods A Delphi process was used between February and October 2017, including a literature review (PubMed and Google Scholar) for published articles on HBV in Jordan, followed by individual interviews with various healthcare professionals and group discussions with leading Jordanian hepatologists and gastroenterologists to provide context to the results of the literature review. Results and discussion The national prevalence of HBV is estimated to be around 2.4% and has declined from 9.9% in the pre-vaccination era. There is limited data on the burden of HBV-related hepatocellular carcinoma in the country. Awareness of various aspects of the disease is considered low among the general population and medium among primary care providers. There are several mandated national screening structures, however, established protocols for those that test positive and subsequent linkage-to-care are not optimal. In conclusion, significant improvements have been made in the past 30 years in Jordan in terms of decline in HBV prevalence. However, efforts must be made by all key stakeholders to optimise screening and linkage-to-care of patients and reduce both morbidity and mortality in the country.

Background and Objective Recent advances in hepatitis C virus (HCV) diagnostic testing methods allow for a one-stop simplified ‘test and cure’ approach. The cost effectiveness of incorporating this simplified approach into HCV screening in Iraq remains uncertain. This study aimed to compare the cost effectiveness of different HCV testing and diagnostic approaches, and screening strategies in Iraq from a health service perspective. Methods A cost-effectiveness analysis was undertaken using a hybrid model comprising a screening decision tree linked to a lifetime Markov model to estimate outcomes in HCV-infected people. Cost and utility estimates were sourced from the published literature and expert guidance provided by clinicians and policy makers in Iraq. Cost estimates were reported in 2019 USD or 2019 Iraqi Dinar and both costs and benefits were discounted at 3.5% annually. Results Strategies using a simplified approach were found to be cost saving in addition to improving patient outcomes when compared with a standard testing and diagnostic approach. When considering risk-based screening, a simplified approach was associated with a total cost saving of Iraqi Dinar 4375 billion (USD 3.7 billion) and per patient life-year and quality-adjusted life-year gains of 0.30 and 0.55, compared with a standard approach. Benefits and cost savings were driven by a 32.2% and 23.6% reduction in the incidence of cirrhosis and hepatocellular carcinoma, respectively. Estimated benefits and cost savings increased under total population screening. All screening and testing and diagnostic approaches were cost effective compared with a no screening scenario. Conclusions Improvements in the detection of HCV combined with a simplified one-stop testing and diagnostic approach represents an opportunity to reduce the burden of HCV in Iraq and may play a significant role in meeting World Health Organisation HCV elimination targets. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-021-01064-z.

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 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.