Disease severity predicts higher healthcare costs among hospitalized nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) patients in Spain

Romero–Gómez, Manuel; Kachru, Nandita; Zamorano, Meritxell Ascanio; Darbà, Josep; Shreay, Sanatan

doi:10.1097/md.0000000000023506

Cited by 17 publications

(14 citation statements)

References 48 publications

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“…Nonalcoholic fatty liver disease (NAFLD) is highly prevalent [1][2][3] and exerts tremendous economic strain on the world economy. [4][5][6] This condition is progressive, may lead to steatohepatitis, and has been linked to cardiovascular disease, diabetes, cirrhosis, and cancer. Steatosis, a hallmark and initiating pathogenic feature, represents fat droplets in hepatocytes.…”

Section: Introductionmentioning

confidence: 99%

Point‐of‐care magnetic resonance technology to measure liver fat: Phantom and first‐in‐human pilot study

Barahman

Grunvald

Prado³

et al. 2022

Magnetic Resonance in Med

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Purpose To assess feasibility and accuracy of point‐of‐care (POC) NMR‐proton density fat fraction (PDFF) in phantoms and in a human pilot study in a POC setting. Methods POC NMR (LiverScope, Livivos, San Diego CA) PDFF measurements were obtained of certified phantoms with known PDFF values (0%‐40%). In an institutional review board‐approved, Health Insurance Portability and Accountability Act‐compliant prospective human study, a convenience sample of participants from an obesity clinic was enrolled (November 2020 to June 2021). The inclusion criteria required body mass index (BMI) = 27‐40 kg/m2 and willingness to undergo POC NMR and MRI‐PDFF measurements. Liver PDFF was measured by POC NMR and, within 35 days after, by a confounder corrected CSE MRI PDFF acquisition and reconstruction method. The adverse events were documented and linear regression analyses were performed. Results POC NMR‐PDFF measurements agreed with known phantom PDFF values (R2 = 0.99). Fourteen participants were enrolled in the pilot human study. MRI‐PDFF could not be obtained in 4 participants (claustrophobia reaction, n = 3, exceeded size of MR scanner bore, n = 1). POC NMR was unevaluable in 2 participants (insufficient signal penetration depth, n = 1, failure to comply with instructions, n = 1). Technical success was 11 of 13 (85%) for POC NMR PDFF. In 7 participants (4 female; 31‐74 years old; median BMI 35 kg/m2), MRI‐PDFF (range, 2.8%‐18.1%), and POC NMR‐PDFF (range, 3%‐25.2%), agreed with R2 = 0.94. POC NMR had no adverse events. Conclusion POC NMR measures PDFF accurately in phantoms and, in a first‐in‐human pilot study, is feasible and accurate in adults with obesity. Further testing to determine precision and accuracy across larger and more diverse cohorts is needed.

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Section: Introductionmentioning

confidence: 99%

Point‐of‐care magnetic resonance technology to measure liver fat: Phantom and first‐in‐human pilot study

Barahman

Grunvald

Prado³

et al. 2022

Magnetic Resonance in Med

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“…The economic model has been largely informed by data from the resmetirom phase II trial in patients with NASH and stage 1-3 fibrosis [18]; in particular, the baseline patient characteristics and the initial distribution of patients across fibrosis health states used in the model. Multiple studies have highlighted the global economic burden associated with NASH and NAFLD [7][8][9][10][11][12], and a clinically beneficial and potentially cost-effective treatment such as resmetirom may reduce this burden.…”

Section: Discussionmentioning

confidence: 99%

“…20 years in the US [7]. Further global studies have demonstrated the significant costs associated with the condition, particularly in the latter stages of disease [8][9][10][11][12].…”

Section: Key Points For Decision Makersmentioning

confidence: 99%

“…As well as having a detrimental impact on patient quality of life, multiple studies have highlighted the significant healthcare costs and utilization of health services associated with NAFLD and NASH [7][8][9][10][11][12]. A 2020 US-based study by Younossi et al described a model developed to estimate economic burden and clinical outcomes associated with the condition over a 20-year time horizon [7].…”

Section: Key Points For Decision Makersmentioning

confidence: 99%

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Early Cost-Effectiveness and Price Threshold Analyses of Resmetirom: An Investigational Treatment for Management of Nonalcoholic Steatohepatitis

Javanbakht¹,

Fishman

Moloney³

et al. 2022

PharmacoEconomics Open

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Background Nonalcoholic steatohepatitis (NASH) is characterized by inflammation and hepatocellular damage caused by accumulation of fat in the liver. Resmetirom (MGL-3196) is an orally administered, small-molecule, liver-targeted, selective thyroid hormone receptor-β agonist. This early analysis explored the potential cost effectiveness of resmetirom for the treatment of NASH from a US commercial payer perspective. Methods An early economic model was developed to reflect the clinical pathways typically followed by patients with NASH and liver fibrosis. Use of resmetirom, compared with placebo, was assessed. The Markov model structure was informed by a previous modeling study and a randomized, double-blind, placebo-controlled, phase II trial of resmetirom. Costs and outcomes were assessed over a lifetime time horizon with results presented in terms of cost per quality-adjusted life-year (QALY) gained. Results Resmetirom treatment resulted in increased costs of US$66,764 per patient, while increasing QALYs by 1.24. The incremental cost-effectiveness ratio was US$53,929 per QALY gained, indicating resmetirom treatment would potentially be cost effective at a willingness-to-pay (WTP) threshold of US$100,000. Results indicated that resmetirom would reduce the lifetime number of cases of decompensated cirrhosis (− 87), hepatocellular carcinoma (− 59), and liver transplants (− 30) per 1,000 patients compared with placebo. Resmetirom treatment remained cost effective at a US$100,000 WTP threshold up to a daily price point of US$72.00. Conclusion Resmetirom is a potentially cost-effective treatment option for patients with NASH and liver fibrosis based on an analysis performed from a US commercial payer perspective. Future economic analyses of the technology should, however, focus on overcoming the limitations of existing modeling methodology.

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“…Both dietary interventions in this SR are in accordance with EASL, ESPEN, AGA, and AASLD guidelines, where a hypocaloric or the Mediterranean diet is suggested as a dietary treatment for NAFLD. However, current guidelines do not address the optimal dietary strategy specifically for active, fibrotic, and cirrhotic NASH, although it contributes to the overall burden of the disease, not only on the t point of view of patients but also economically on the public health (77)(78)(79)(80). Due to this burden, different stages, especially active and fibrotic NASH, cannot be disregarded when designing future studies.…”

Section: Discussionmentioning

confidence: 99%

Dietary Interventions in Patients With Non-alcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis

et al. 2021

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Background: With no approved pharmacotherapy to date, the present therapeutic cornerstone for non-alcoholic fatty liver diseases (NAFLD) is a lifestyle intervention. Guidelines endorse weight loss through dietary modifications, physical exercise, or both. However, no consensus exists on the optimal dietary treatment.Objectives: The aim of our systematic review and meta-analysis was to summarize and assess the evidence for applied types of dietary interventions on the liver and metabolic outcomes in patients with NAFLD, aside from any effects of exercise intervention.Methods: This systematic review was conducted according to the Preferred Reporting Items of Systematic Reviews and Meta-analysis (PRISMA) statement guidelines. The search was conducted in PubMed, Scopus, and Cochrane databases in February 2020. Included were only dietary interventions without exercise. This study was registered at PROSPERO: CRD42020203573.Results: Eight randomized controlled trials, seven with endpoint reduction of hepatic steatosis, one with an assessment of endpoint fibrosis, were included in this systematic review, five of which were included in the meta-analysis. Mediterranean dietary interventions without energy restriction (n = 3) showed significant reduction of intrahepatic lipid content (IHL) (SDM: −0.57, 95% CI: −1.04, −0.10), but there was no significant change in alanine transaminase (ALT) (SDM: 0.59, 95% CI: −0.5, −1.68). Hypocaloric dietary interventions with foods high in unsaturated fatty acids (n = 2) led to a significant decrease in ALT (SDM: −1.09, 95% CI: −1.49, −0.69) and aspartate aminotransferase (AST) (SDM: −0.75, 95% CI: −1.27, 0.23); yet effects on steatosis could not be aggregated due to different assessment techniques. Mediterranean diet did not lead to significant changes in concentrations of gamma-glutamyl transpeptidase (γGT), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), fasting glucose or insulin, or homeostatic assessment for insulin resistance.Conclusions: In patients with NAFLD, Mediterranean and hypocaloric dietary interventions favoring unsaturated fatty acids result in improvements in IHL and transaminases. Since many dietary intervention studies are combined with exercise interventions and there is a paucity of ample-sized studies examining dietary interventions on the more advanced and clinically relevant stages of NAFLD, that is active and fibrotic NASH, with multiparametric imaging and liver histology as outcome measures, the optimal dietary invention in NAFLD remains to be defined.

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Disease severity predicts higher healthcare costs among hospitalized nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) patients in Spain

Cited by 17 publications

References 48 publications

Point‐of‐care magnetic resonance technology to measure liver fat: Phantom and first‐in‐human pilot study

Point‐of‐care magnetic resonance technology to measure liver fat: Phantom and first‐in‐human pilot study

Early Cost-Effectiveness and Price Threshold Analyses of Resmetirom: An Investigational Treatment for Management of Nonalcoholic Steatohepatitis

Dietary Interventions in Patients With Non-alcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis

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