A Four-Country Modelling Study on Doubling MASH Diagnostic Rates by 2027

Contact information

Jeffrey V. Lazarus

CUNY Graduate School of Public Health and Health Policy, New York, NY, USA Jeffrey.Lazarus@sph.cuny.edu

Introduction

A four-country modelling study on doubling MASH diagnostic rates by 2027

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

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, CharitéUniversitätsmedizin Berlin, Berlin, Germany 13Houston Methodist Hospital, Houston Research Institute, Houston, TX, USA.

• 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.

• 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

• 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.

Results Aim

• 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).

Proportion of confirmatory tests by healthcare setting in 2022 and 2027 2022 2027 Figure 2:

Conclusions

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.