Madrigal Pharmaceuticals, Inc. announced five health economics abstracts being presented at the NASH-TAG Conference, taking place from January 4-6, 2024 in Park City, Utah. A summary of the health economics outcomes research abstracts being presented at NASH-TAG follows: Abstract #21: ?Non-invasive tests as a prediction tool to assess MASH resolution score? [Presenter: Jesse Fishman] In an evaluation of biopsy and noninvasive test data from patients included in the TARGET-NASH registry, the FibroScan-AST score (FAST), FibroScan vibration-controlled transient elastography (VCTE), and the aspartate aminotransferase-to-platelet ratio index (APRI) demonstrated a strong ability to predict NASH resolution.

Overall, patients without NASH resolution had larger baseline median FIB-4 (1.7 vs. 1.4, p<0.003), APRI (0.7 vs. 0.5, p<.0001) and VCTE (12.5 vs.

8.4, p=0.0054) scores. Sequential testing with two or three noninvasive tests helped reduce indeterminate results. Abstract #25: ?Characterizing the management of patients with NASH (with versus without cirrhosis) in real-world clinical practice ?

Low utilization of gastroenterology and hepatology specialty care? [Presenter: Michael Charlton]: In a review of patient records from an Optum database, researchers found that a substantial proportion of patients with NASH were not assessed by a gastroenterologist or hepatologist at the frequency recommended in medical guidelines, even when diagnosed with cirrhosis. Among patients with cirrhosis, =25% were not seen by a specialist at the recommended frequency of once per year.

Among those without cirrhosis, =50% were not assessed by a specialist at the recommended frequency of every 2-3 years. Screening for hepatocellular carcinoma for most patients with cirrhosis occurred less than the recommended frequency. The findings suggest a need to improve clinical practice to align with clinical guidelines.

Abstract #26: ?Characterizing the real-world clinical outcomes of patients with NASH without cirrhosis versus with cirrhosis? [Presenter: Michael Charlton]: In another review of patient records from an Optum database, researchers examined the relationship between NASH disease progression and risk of clinical outcomes. For patients with NASH without cirrhosis at baseline, the risk of experiencing all-cause death, progression to cirrhosis or decompensated cirrhosis, or a liver transplant increased from 10.5% in year one to 31.4% by year five.

The risk of death was several-fold higher for those with cirrhosis. This study also found that the risk of death and progression increased significantly with age and presence of comorbidities of cardiovascular disease and type 2 diabetes, highlighting the importance of delaying liver disease progression. Abstract #27: ?A longitudinal assessment of cardiovascular risk for patients enrolled in TARGET-NASH?

[Presenter: Jesse Fishman]: In an analysis of patient data from the TARGET-NASH registry, patients with NASH with cirrhosis were found to be at an increased risk of cardiovascular events compared to patients with noncirrhotic NASH, even after adjusting for traditional cardiovascular risk factors: this finding supports the notion that the severity of liver disease impacts the level of cardiovascular risk and suggests that treatments that could delay progression to cirrhosis may potentially reduce health events like cardiovascular outcomes, morbidity, and mortality in patients with NASH. Abstract #41: ?Enhancing ASCVD Risk Prediction in NASH/NAFLD Patients? [Presenter: Jesse Fishman]: In an analysis of a retrospective dataset from a large U.S. integrated delivery network health system, researchers compared observed events to a model that predicted events and found that a cardiovascular risk model that included liver-specific biomarkers improved the prediction of cardiovascular mortality and myocardial infarction events in patients with NASH relative to the American Heart Association's Atherosclerotic Cardiovascular Disease Risk Estimator Plus.

This finding underscores the necessity of revisiting current cardiovascular risk models for patients with NASH to incorporate more holistic and liver-specific variables.