A four-country modelling study on doubling MASH diagnostic rates by 2027 Jeffrey V. Lazarus CUNY Graduate School of Public Health and Health Policy, New York, NY, USA Jeffrey.Lazarus@sph.cuny.edu
1Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, University of Barcelona, Barcelona, Spain. 2Barts Liver Centre, Blizard Institute, Queen Mary University of London, London, UK. 3Division of Gastroenterology and
Hepatology, Department of Medicine, Mayo Clinic, Rochester, MN, USA. 4Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK 5Human Development & Heath, Faculty of Medicine, University of Southampton, Southampton, UK. 6Université Paris Cité, Department of Hepatology, Hospital Beaujon, AP-HP, Clichy, Paris, France. 7Endocrinology Diabetes Nutrition Hospices Civils de Lyon, Lyon, France. 8Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Florida, Gainesville, FL, USA. 9Division of Endocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA. 10 Novo Nordisk, Copenhagen, Denmark. 11Department of Endocrinology and Diabetology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany. 12Department of Hepatology & Gastroenterology, Charité Universitätsmedizin Berlin, Berlin, Germany. 13Houston Methodist Hospital, Houston Research Institute, Houston, TX, USA.
Introduction Cumulative diagnoses
• With high and increasing prevalence, but low diagnosis rates, identifying people living with MASH who require specialised care remains a significant challenge. • Non-invasive tests (NITs) promise to revolutionise diagnostic pathways, but little focus has been given to operational considerations for implementing MASH diagnostic pathways at scale.
Aim
4.500.000
35%
4.000.000
30%
3.500.000
• For each country, we used a 2021 baseline general population prevalence and diagnostic rate of ≥F2 MASH, defined as the cumulative proportion of all MASH patients diagnosed with ≥F2 MASH at the end of a given year. • Diagnostic pathways were constructed covering identification (e.g. abnormal liver function test), screening (e.g. FIB-4) and confirmatory diagnosis (e.g. FibroScan, Enhanced Liver Fibrosis, biopsy). • A weighted average sensitivity and specificity was used for each stage in the pathway depending on the proportion of different NITs used. • The model incorporated 5 healthcare settings – hepatology/GI office, hepatology/GI hospital, endocrinologist office and endocrinologist hospital, and primary care (PC) – and 4 patient pools (symptom led, obesity, type 2 diabetes mellitus [T2DM] and cardiovascular disease [CVD]). • We accounted for annual growth in MASH prevalence and bottlenecks in provider capacity across healthcare settings, adjusting future testing requirements accordingly.
2.500.000
20%
2.000.000
15%
1.500.000
• Doubling of the diagnostic rates of ≥F2 MASH across the four countries will result in the number of diagnosed patients increasing from 2.6m to 6.1m between 2022-2027 (Figure 1) • The number of screening tests will increase from 2.2m to 35.6m and confirmatory diagnosis tests from 833,000 to 11.6m, between 2022-2027. • To address capacity bottlenecks, the proportion of confirmatory diagnostic tests completed within liver specific settings will need to decrease from 95% in 2022 to 29% in 2027 and increase from 1% to 27% in primary care and from 4% to 34% in non-liver offices and non-liver clinic settings over the same time (Figure 2). • In 2027, the share of confirmatory tests that were true positive and false positive was 48% and 58%, and true negative and false negative was 93% and 7%. • The breakdown of diagnosis by patient pool changes marginally between 2022-2027, with over half of diagnoses coming from within the T2DM patient pool in both 2022 and 2027 (Figure 3).
10%
1.000.000 500.000
5%
-
0% 2022
2023
2024 France Germany
2025 UK USA
2026
2027
Figure 1: Modelled cumulative diagnoses and diagnosis rate in France, Germany, the UK and USA between 2022-2027
Diagnosis by patient pool in 2022 and 2027
Proportion of confirmatory tests by healthcare setting in 2022 and 2027 70%
60% 52%
61%
60%
50%
52%
43%
50%
40%
40% 30%
27% 18%
20%
16%
18%
20%
1%
2%
30% 20%
10%
10%
2%
0%
21% 18%
18%
12%11%
8%
0% PCP
Results
25%
3.000.000
• To estimate the testing requirements to double the diagnostic rates of ≥F2 MASH over a 5-year period in France, Germany, the United Kingdom (UK) and the United States of America (USA).
Method
Abstract:1992
Diagnostic rate
Contact information
Jeffrey V. Lazarus1, Henry E Mark1, William Alazawi2, Alina M. Allen3, Paul N. Brennan4, Christopher D. Byrne5, Laurent Castera6, Cyrielle Caussy7, Kenneth Cusi8, Martin M. Grajower9, Morten Faarbæk Mikkelstrup10, Michael Roden11, Frank Tacke12, Mazen Noureddin13
Endocrinologist Endocrinologist Hepatology/GI office hospital office 2022 2027
Hepatology/GI hospital
Figure 2: Changes in confirmatory tests by healthcare setting between 2022-2027
Conclusions
Symptom led
Obesity 2022
T2DM
CVD
2027
Figure 3: Changes in diagnosis by patient pool between 2022-2027
Doubling the diagnosis rate of ≥F2 MASH by 2027 will require enormous expansion of diagnostic pathways. This necessitates a paradigm shift and greater collaboration across disciplines, with much of the testing burden moving from liver specialists to primary care and non-liver specialist settings. Identifying efficient approaches to reduce the operational burden and costs of this expansion will be key for success.
Acknowledgements The authors acknowledge financial support from Novo Nordisk and Echosens for this abstract.