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Background Non-alcoholic steatohepatitis (NASH) is a severe, typically progressive form of non-alcoholic fatty liver disease (NAFLD). The global prevalence of NASH is increasing, driven partly by the global increase in obesity and type 2 diabetes mellitus (T2DM), such that NASH is now a leading cause of cirrhosis. There is currently an unmet clinical need for efficacious and cost-effective treatments for NASH; no pharmacologic agents have an approved indication for NASH. Objective Our objective was to summarise and critically appraise published health economic models of NASH, to evaluate their quality and suitability for use in the assessment of novel treatments for NASH, and to identify knowledge gaps, challenges and opportunities for future modelling. Methods A systematic literature review was performed using the MEDLINE, Embase, Cochrane Library and EconLit databases to identify published health economic analyses in patients with NAFLD or NASH. Supplementary hand searches of grey literature were also performed. Articles published up to November 2019 were included in the review. Quality assessment of identified studies was also performed. Results A total of 19 articles comprising 16 unique models including either NAFLD as a whole or NASH alone were included in the review. Structurally, most models had a state-transition component; in terms of health states, two different approaches to early disease states were used, modelling either progression through fibrosis stages or NAFLD/NASH-specific health states. Conditions that frequently co-exist with NASH, such as obesity, T2DM and cardiovascular disease were not captured in models identified here. Late-stage complications such as cirrhosis, decompensated cirrhosis and hepatocellular carcinoma were consistently included, but input data (e.g. costs, utilities and transition probabilities) for late-stage complications were frequently sourced from other liver disease areas. The quality of included studies was heterogenous, and only a small proportion of studies reported internal and external validation processes. Conclusion The health economic models identified in this review are associated with limitations primarily driven by a lack of NASH-specific data. Identified models also largely overlooked the intricate association between NASH and other conditions, including obesity and T2DM, and did not capture the increased risk of cardiovascular events associated with NASH. High-quality, transparent, validated health economic models of NASH will be required to evaluate the cost effectiveness of treatments currently in development, particularly compounds that may target other non-hepatic outcomes.

ObjectiveTo characterise patients with metabolic dysfunction-associated steatohepatitis (MASH) in England and to estimate its associated healthcare resource use (HCRU) and costs, both overall and by progression status and comorbidities.DesignThis was a retrospective observational study of adults with a MASH-coded primary and/or secondary care recorded diagnosis in England (2011–2020). The analysis used data from the Clinical Practice Research Datalink linked to the Hospital Episode Statistics and death registrations. Annualised all-cause and MASH-related (ie, coded as MASH, end-stage liver disease or major adverse cardiovascular event) HCRU and costs were calculated for patients with incident MASH. Subgroup analyses were conducted for patients with type 2 diabetes, overweight/obesity, cardiovascular disease or progression to cirrhosis. Comparative cost analysis was conducted between those with progressed MASH and those who did not progress.ResultsA total of 2696 patients were included (mean follow-up: 4 years). Incidence of MASH was estimated at 4.7 per 100 000 person-years overall and increased among patients with key comorbidities. Patients who had type 2 diabetes had greater HCRU and costs than those who did not (eg, mean 1.8 vs 1.0 all-cause inpatient admissions and £2227 vs £1151 all-cause inpatient costs per-patient per-year). Some patients with MASH progressed to compensated (8.6%) or decompensated cirrhosis (6.5%) during the study. HCRU and costs were substantially higher among patients who progressed than among those who did not (eg, mean 2.4 vs 1.1 all-cause inpatient admissions and £3620 vs £1290 all-cause inpatient costs per-patient per-year).ConclusionHCRU and costs associated with MASH are higher among patients who have cardiometabolic comorbidities or who progress to advanced disease stages. Therefore, efforts to detect cases early and prevent disease progression could reduce healthcare burden.

Our study assessed the cost-effectiveness of screening for hepatic fibrosis in cases suspected of metabolic dysfunction-associated steatotic liver disease (MASLD) using serological noninvasive tests like the fatty liver index (FLI) and hepatic steatosis index (HSI). We applied a decision tree and Markov model from a healthcare system perspective to estimate life-years, quality-adjusted life-years (QALYs), costs, and the incremental cost-effectiveness ratio (ICER) for screening versus no screening in the United States. Prevalence of advanced hepatic fibrosis in individuals suspected of having MASLD was significantly higher when defined by FLI (10.6% vs. 1.3%, P  < 0.001) and HSI (8.6% vs. 2.2%, P  < 0.001), compared to those without MASLD. Screening (base case) for suspected MASLD defined by FLI had an ICER of $78,647 per QALY and by HSI, $84,874 per QALY, both of which were considered cost-effective based on the implicit ICER threshold of $100,000/QALY in the United States. However, screening for other subgroups without evidence of MASLD was not deemed cost-effective. When applying medical costs and fibrosis distribution data from Korea, similar results were observed. Implementing a two-step screening algorithm for advanced hepatic fibrosis in patients with suspected MASLD based on HSI or FLI calculation is cost-effective in primary care settings.

Most international guidelines recommend a two-step approach using the Fibrosis-4 index (FIB-4) and vibration-controlled transient elastography (VCTE) to identify advanced fibrosis, a key predictor of all-cause and liver-related mortality in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). However, VCTE is not available in most primary care settings in Malaysia, and there is scarce data on the cost-effectiveness of different approaches. This study evaluated the cost-effectiveness of three referral pathways for identifying advanced fibrosis among type 2 diabetes mellitus(T2DM) patients with MASLD. We developed a decision-analytical model from the healthcare provider's perspective, using 1,000 simulated patients to compare: (i) Current Practice (direct referral based on elevated alanine transaminase), (ii) Clinical Practice Guidelines (CPG) Pathway using FIB-4 single-cutoff 1.3, and (iii) FIB-4 dual-cutoffs (1.3,3.25) followed by a gamma-glutamyl transferase (GGT) test for indeterminate cases (Sequential FIB-4/GGT Pathway). Current practice served as the reference comparator. The primary outcomes were the average cost-effectiveness ratio (ACER) and the incremental cost-effectiveness ratio (ICER). Model parameters were mainly derived from local studies. Direct medical costs were reported in 2024 Malaysian Ringgit (MYR). Sequential FIB-4/GGT pathway had the lowest ACER at MYR930 per advanced fibrosis case identified, compared to MYR1,299 for current practice and MYR1,581 for the CPG pathway. Sequential FIB-4/GGT pathway was potentially more effective and less costly, demonstrating dominance over current practice with a cost savings of MYR2,911/additional advanced fibrosis case identified. CPG pathway was more effective and more costly than current practice, with an ICER of MYR3,785. Sequential FIB-4/GGT pathway was cost-effective for identifying advanced fibrosis in T2DM patients with MASLD. This pragmatic approach could reduce tertiary care referrals, lower healthcare resource use and costs compared to current practice. CPG pathway was more effective than current practice, but incurred higher costs and required increased availability of VCTE within clinical practice.

INTRODUCTION:Ultrasound (US) is associated with severe visualization limitations (US Liver Imaging Reporting and Data System visualization score C) in one-third of patients with nonalcoholic fatty liver disease (NAFLD) cirrhosis undergoing hepatocellular carcinoma (HCC) screening. Data suggest abbreviated MRI (aMRI) may improve HCC screening efficacy. This study analyzed the cost-effectiveness of HCC screening strategies, including an US visualization score-based approach with aMRI, in patients with NAFLD cirrhosis.METHODS:We constructed a Markov model simulating adults with compensated NAFLD cirrhosis in the United States undergoing HCC screening, comparing strategies of US plus visualization score, US alone, or no surveillance. We modeled aMRI in patients with visualization score C and negative US, while patients with scores A/B did US alone. We performed a sensitivity analysis comparing US plus visualization score with US plus alpha fetoprotein or no surveillance. The primary outcome was the incremental cost-effectiveness ratio (ICER), with a willingness-to-pay threshold of $100,000 per quality-adjusted life-year. Sensitivity analyses were performed for all variables.RESULTS:US plus visualization score was the most cost-effective strategy, with an ICER of $59,005 relative to no surveillance. The ICER for US alone to US plus visualization score was $822,500. On sensitivity analysis, screening using US plus visualization score remained preferred across several parameters. Even with alpha fetoprotein added to US, the US plus visualization score strategy remained cost-effective, with an ICER of $62,799 compared with no surveillance.DISCUSSION:HCC surveillance using US visualization score-based approach, using aMRI for visualization score C, seems to be the most cost-effective strategy in patients with NAFLD cirrhosis.

Background The identification of patients with advanced liver fibrosis secondary to non-alcoholic fatty liver disease (NAFLD) remains challenging. Using non-invasive liver fibrosis tests (NILT) in primary care may permit earlier detection of patients with clinically significant disease for specialist review, and reduce unnecessary referral of patients with mild disease. We constructed an analytical model to assess the clinical and cost differentials of such strategies. Methods A probabilistic decisional model simulated a cohort of 1000 NAFLD patients over 1 year from a healthcare payer perspective. Simulations compared standard care (SC) (scenario 1) to: Scenario 2: FIB-4 for all patients followed by Enhanced Liver Fibrosis (ELF) test for patients with indeterminate FIB-4 results; Scenario 3: FIB-4 followed by fibroscan for indeterminate FIB-4; Scenario 4: ELF alone; and Scenario 5: fibroscan alone. Model estimates were derived from the published literature. The primary outcome was cost per case of advanced fibrosis detected. Results Introduction of NILT increased detection of advanced fibrosis over 1 year by 114, 118, 129 and 137% compared to SC in scenarios 2, 3, 4 and 5 respectively with reduction in unnecessary referrals by 85, 78, 71 and 42% respectively. The cost per case of advanced fibrosis (METAVIR ≥F3) detected was £25,543, £8932, £9083, £9487 and £10,351 in scenarios 1, 2, 3, 4 and 5 respectively. Total budget spend was reduced by 25.2, 22.7, 15.1 and 4.0% in Scenarios 2, 3, 4 and 5 compared to £670 K at baseline. Conclusion Our analyses suggest that the use of NILT in primary care can increases early detection of advanced liver fibrosis and reduce unnecessary referral of patients with mild disease and is cost efficient. Adopting a two-tier approach improves resource utilization.

Purpose Vibration-controlled transient elastographies (VCTEs) are used to surveil disease progression in metabolic dysfunction-associated steatotic liver disease (MASLD), but this test is not covered by Florida Medicaid. This study aims to quantify the number of MASLD adults in a tertiary care center who did not obtain VCTEs despite indications for one based on their fibrosis-4 (FIB-4) scores, estimate the downstream costs associated with lack of VCTE access, and extrapolate these findings to the broader Florida Medicaid population. Methods The study population was categorized into fibrosis risk groups based on their FIB-4 scores. For each insurance group (Medicaid, Medicare, and private), elastography studies and costs were collected and compared in patients who did or did not receive them. This data were then extrapolated to the statewide Medicaid MASLD population. Results Among 282 MASLD patients with Medicaid, 64 patients were categorized as “intermediate-risk” for fibrosis based on their FIB-4, but only 4 had VCTEs performed. The number of VCTEs performed was significantly lower in the Medicaid group in comparison to all “intermediate-risk” patients with Medicaid, Medicare, and private insurance [ χ 2 (2, N  = 622) = 19.8, p  < 0.001]. In the “intermediate-risk” Medicaid patients, the VCTE and non-VCTE groups averaged $86.74 ± 23.91 and $424.95 ± 63.49 per patient-year ( p  = 0.01), respectively, in elastography costs. When extrapolating these findings to the statewide Medicaid MASLD population, performing at least one VCTE could reduce downstream elastography costs by $136,020,921.51 ± 27,299,855.72 annually. Conclusion VCTEs are underutilized in MASLD patients with Medicaid and VCTE use is associated with significantly lower downstream healthcare costs.

Screening for metabolic dysfunction-associated steatotic liver disease (MASLD) across the entire general population is not currently a recommended strategy. However, it is not uncommon to receive a medical check-up or health check-up for a various of reasons. We tried to investigate whether advanced fibrosis screening in MASLD patients is cost-effective for adults aged 40–49 years during medical or health check-up. The target group for analysis was adults who received medical check-ups for various reasons in the United States. We constructed a hybrid model of the decision tree model and Markov model to compare expected costs and quality-adjusted life-years (QALYs) between ‘screening’ and ‘no screening’ groups from healthcare system perspectives. Patients diagnosed MASLD with advanced fibrosis by FIB4 and VCTE were given intensive lifestyle intervention (ILI). The incremental cost-effectiveness ratio (ICER) was calculated for a 30-year horizon. Assuming effect of ILI is limited to regression of liver fibrosis, ICER of the FIB-4-based two steps algorithm was $103,405 per QALY in adults aged 40–49 years, which was slightly above the threshold value ($100,000/QALY). And in those in adults aged 50–59 and 60–69 years, the ICER was $137,593 and $197,901 per QALY, respectively. If we assume the effect of ILI can improve liver fibrosis as well as cardiovascular disease events, ICERs of screening in aged 40–49 and 50–59 years were $74,596, and $95,974 per QALY, respectively. In an analysis that included additional positive effect on extrahepatic cancer by ILI, estimated ICERs were below the threshold in those in aged 40–49 and 50–59 years. Advanced fibrosis screening in MASLD patients using the FIB-4-based two-step algorithm and ILI was cost-effective for adults aged 40–49 years, taking into account both liver fibrosis and cardiovascular disease.

Background and AimsLiver cirrhosis is a substantial health burden in the USA, but population-based data regarding the trend and medical expenditure are limited and outdated. We investigated the trends of inpatient admissions, costs, and inpatient mortality from 2005 to 2015 among cirrhotic patients.MethodsA retrospective analysis was conducted using the National Inpatient Sample database. We adjusted the costs to 2015 US dollars using a 3% inflation rate. National estimates of admissions were determined using discharge weights.ResultsWe identified 1,627,348 admissions in cirrhotic patients between 2005 and 2015. From 2005 to 2015, the number of weighted admissions in cirrhotic patients almost doubled (from 505,032 to 961,650) and the total annual hospitalization cost in this population increased three times (from 5.8 to 16.3 billion US dollars). Notably, admission rates varied by liver disease etiology, decreasing from 2005 to 2015 among patients with hepatitis C virus (HCV)-related cirrhosis while increasing (almost tripled) among patients with nonalcoholic fatty liver disease (NAFLD)-related cirrhosis. The annual inpatient mortality rate per 1000 admissions overall decreased from 63.8 to 58.2 between 2005 and 2015 except for NAFLD (27.2 to 35.8) (P < 0.001).ConclusionsRates and costs of admissions in cirrhotic patients have increased substantially between 2005 and 2015 in the USA, but varied by liver disease etiology, with decreasing rate for HCV-associated cirrhosis and for HBV-associated cirrhosis but increasing for NAFLD-associated cirrhosis. Inpatient mortality also increased by one-third for NAFLD, while it decreased for other diseases. Cost also varied by etiology and lower for HCV-associated cirrhosis.

Background Metabolic dysfunction-associated steatohepatitis (MASH) is commonly comorbid with metabolic syndrome; however, MASH can occur in the absence of metabolic syndrome. This retrospective cohort study evaluated the patient characteristics, healthcare utilization, and healthcare costs among patients with MASH with and without metabolic syndrome, obesity, and type 2 diabetes/elevated fasting glucose. Methods In a linked dataset of electronic health records (Veradigm Network EHR) and claims (Komodo Health), we identified adults with a MASH diagnosis code (7/1/2018-3/15/2023) and ≥12 months of continuous enrollment pre- and post-MASH diagnosis. Patients with other causes of liver disease, gestational or type 1 diabetes, or bariatric surgery were excluded. Six cohorts were identified: 1) MASH with metabolic syndrome, 2) MASH without metabolic syndrome, 3) MASH with body mass index (BMI) <25, 4) MASH with a BMI <25 and metabolic syndrome, 5) MASH with a BMI <25 without metabolic syndrome, and 6) MASH with a BMI <25 without metabolic syndrome or type 2 diabetes/elevated fasting glucose. We captured demographics, clinical characteristics, all-cause healthcare utilization, and costs. Results We identified 98,199 patients with MASH, of which 34.4% did not have metabolic syndrome, and 3.1% had a BMI <25. Mean (standard deviation) annualized all-cause healthcare costs exceeded $19,000 in all cohorts and ranged from $19,018 ($60,359) among patients with a BMI <25 without metabolic syndrome or type 2 diabetes/elevated fasting glucose to $32,592 ($337,462) among patients with metabolic syndrome. Median (interquartile range) costs ranged from $5,336 ($2,085-$14,839) to $11,373 ($4,478-$27,243), and mean costs after excluding the top 1% of spenders ranged from $14,355 ($25,868) to $21,878 ($30,755). Trends were consistent when the analysis was expanded to include patients without a documented BMI. Conclusions Metabolic syndrome is commonly comorbid with MASH; however, all-cause healthcare costs remain high even among the subpopulation without metabolic syndrome, elevated BMI, or type 2 diabetes/elevated fasting glucose.