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High Cost Of Advanced Non-alcoholic Fatty Liver Disease/non-alcoholic Steatohepatitis (NAFLD/NASH) Revealed But Screening High-risk Patients May Not Be Cost Effective

ILC 2019: Italian study reveals high cost of advanced liver disease in NAFLD/NASH patients and missed opportunities to diagnose earlier, yet screening high-risk individuals for NAFLD may not be cost effective if treatments are too expensive

11 April 2019, Vienna, Austria

EASL (EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER)

The high cost of treating advanced liver disease in patients with non-alcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) has been revealed in a study presented today at The International Liver Congress™ 2019 in Vienna, Austria. The results highlight potential missed opportunities for early diagnosis and treatment, and the need to improve this to avoid the high economic burden associated with disease progression. However, a second study suggested that screening for NAFLD in a high-risk population (patients with diabetes) would not be cost-effective if treatment options are too expensive.

NAFLD is the most prevalent form of chronic liver disease in the world, paralleling the epidemic of obesity and type 2 diabetes mellitus.1,2 The natural history of NAFLD in some individuals is to progress from NAFLD to NASH, cirrhosis, hepatocellular carcinoma (HCC), and end-stage liver disease, and the presence of type 2 diabetes is thought to play a key role in its progression.2 The costs associated with the care of patients with NAFLD have recently been found to be very high,3,4 however, there is a lack of real-world data on the true economic burden of the condition.3

The first study aimed to characterize the health resource utilization and costs associated with patients with NAFLD/NASH and advanced liver disease (defined as NAFLD/NASH patients with compensated cirrhosis [CC], decompensated cirrhosis [DCC], liver transplant [LT], or HCC). Investigators studied the records of almost 10,000 NAFLD/NASH patients in Italy who were hospitalized during the study period (2011–2017) and identified 131 individuals (1.3%) with CC, 303 (3.1%) with DCC, 11 (0.1%) with LT, and 79 (0.8%) with HCC. NAFLD/NASH patients with advanced liver disease were hospitalized, on average, 4.2–4.4 times per year compared with 2.9 times for patients without advanced liver disease (p≤0.05). The total mean annual healthcare costs associated with hospitalized NAFLD/NASH patients were at least 86% higher in those with advanced liver disease versus those without, primarily as a result of higher inpatients costs: €10,576 for NAFLD/NASH patients without advanced liver disease, €19,681 for those with CC, €19,808 for those with DCC, €65,137 for those with LT, and €26,220 for those with HCC (2017 total annual costs; p<0.001 for all comparisons). A similar trend was observed  after adjusting these costs for patient characteristics and comorbidities such as type 2 diabetes and cardiovascular disease, suggesting that liver-related complications accounted for at least 50% of total healthcare costs among patients with advanced liver disease:  €2,418 for those without advanced liver disease, versus €9,318 for those with CC, €9,717 for those with DCC, €55,677 for those with LT, and €16,185 for those with HCC (p<0.01 for CC, DCC, and HCC; p=0.08 for LT).

‘The annual costs associated with NAFLD/NASH patients with advanced liver disease are extremely high and increase as liver disease progresses, highlighting the need for effective interventions to prevent progression,’ said Dr Salvatore Petta from the University of Palermo in Italy. ‘Additionally, in our study, there was a lower prevalence of CC compared with DCC, suggesting a missed opportunity to diagnose the disease at an earlier stage.’

So could screening for NAFLD in high-risk populations be cost effective?

Not according to a group of Israeli researchers, who presented their findings in Vienna today. In the Israeli study, a computer model was constructed to assess the impact of screening for liver fibrosis using elastography in individuals with diabetes, with a hypothetical new treatment capable of reducing the annual rate of progression by 15% and increasing the rate of regression by 15% being given to patients found to have NASH and significant liver fibrosis (F2–F3). In the model, individuals with cirrhosis would be managed according to current guidelines. The annual cost of the hypothetical new treatment was set in the range of $20,000 to $100,000.

‘We were motivated to do this analysis in-line with guideline recommendations to screen patients with diabetes for NAFLD5 and in-light of recent findings that several novel interventions have been shown to improve fibrosis in NAFLD/NASH,6’ explained Dr Yaakov Maor from the Institute of Gastroenterology and Hepatology in Rehovot, Israel.

According to these researchers, if a new treatment was to cost $40,000 per year, the average cost of a screening strategy would be $213,347, with a no-screening strategy costing $94,791 (a difference of $118,556). The average quality-adjusted life-year (QALY) of the screening strategy would be 15.86 compared with 15.25 for the no-screening strategy (a difference of 0.61), and the incremental cost-effectiveness ratio (ICER) would be $195,481 per QALY. In contrast, if the annual cost of a new treatment was to be $100,000, the ICER would increase to $509,301 per QALY.

‘What this shows us is that, for a NAFLD screening strategy in patients with diabetes to be cost effective, the cost of any new treatments must be relatively low: approximately ~$40,000 per year,’ said Dr Maor. ‘It will be important to reassess this when more effective medications become available.’

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About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ 2019 will take place from 10­–14 April 2019 at the Reed Messe Wien Congress and Exhibition Center, Vienna, Austria.

About The European Association for the Study of the Liver (EASL)

Since its foundation in 1966, this not-for-profit organization has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Contact

For more information, please contact the ILC Press Office at:

Onsite location reference

Session title: ‘NAFLD – Clinical burden natural history’

Time, date and location of session: 17:00–17:15, 11 April 2019, Strauss 1–2

Presenter: Jie Ting, USA

Abstract: Non-alcoholic fatty liver disease/Non-alcoholic steatohepatitis patients with advanced liver disease had high burden of comorbidities, healthcare resource utilization and costs: Results from Italian administrative databases (PS-061)

Session title: ‘NAFLD – Clinical burden natural history’

Time, date and location of session: 17:30–17:45, 11 April 2019, Strauss 1–2

Presenter: Yaakov Maor, Israel

Abstract: Screening diabetic patients for non-alcoholic fatty liver disease: Is it cost-effective (PS-063)

Author disclosures

Salvatore Petta is an advisor to Gilead Sciences Inc. Jie Ting is an employee of Gilead Sciences Inc, during the conduct of this study. The study he presented was funded by Gilead Sciences Inc.

Yaakov Maor has no relevant disclosures.

References

  1. Marcellin P, Kutala Liver diseases: A major, neglected global public health problem requiring urgent actions and large-scale screening. Liver Int. 2018;38 Suppl 1:2–6.
  2. BertotLC, Adams LA. The natural course of non-alcoholic fatty liver disease. Int J Mol Sci. 2016; 17(5): 774.
  3. Allen AM et al. Healthcare cost and utilization in nonalcoholic fatty liver disease: real-world data from a large U.S. claims database. 2018;68(6):2230–38.
  4. Sayiner M, et al. Variables associated with inpatient and outpatient resource utilization among Medicare beneficiaries with nonalcoholic fatty liver disease with or without cirrhosis. J Clin Gastroenterol. 2017;51(3):254–60.
  5. European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016;64(6):1388–402.

Sumida Y, Yoneda M. Current and future pharmacological therapies for NAFLD/NASH. J Gastroenterol. 2018;53(3):362–76.