Fibrosis-4 score (FIB-4) provides consistent assessment of healthcare costs and healthcare resource utilization (HCRU) among nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) patients with advanced fibrosis.

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Background: Hepatic fibrosis is the single most important predictor of morbidity and mortality among NAFLD/NASH patients. Due to lack of specific diagnosis codes for fibrosis stages and liver-biopsy data, limited data exists around the economic and clinical burden of advanced fibrosis (bridging fibrosis/F3 and compensated cirrhosis/F4) in the US. This study characterized total healthcare costs/HCRU among NAFLD/NASH patients with F3/F4. Methods: NAFLD/ NASH patients aged ≥18 years were identified (ICD-9/10-CM codes) from 2008-2016 using commercial Optum Research Database. Patients with no history of cirrhosis or hepatocellular carcinoma or liver transplant, having AST, ALT and platelet results within 180 days of each other were identified to calculate their FIB-4. Based on expert opinion and published literature, a comprehensive FIB-4 based F3/F4 identification algorithm with 3 separate criteria was developed-Criteria 1 [C1], Criteria 2 [C2], Criteria 3 [C3]. (Table) The first encounter of C1, C2 and C3 were assigned as F3/F4 index dates. Mean annual total healthcare costs/ HCRU was calculated through per member per month values as per 2016 USD. Results: Among 91,122 NAFLD/NASH patients with available FIB-4 scores, 3,251 (3.6%) had F3/F4 based on C1. When using C2, 2482 (2.7%) had F3 and 939 (1.0%) had F4, and when using C3, 363 (0.4%) had F3 and 1463 (1.6%) had F4. The mean age (56-58 years) and sex distribution (45-48% females) were comparable for all criteria used. The high comorbidity burden was also similar across all cohorts (C1-C3)-hypertension (57-59%), hyperlipidemia (50-54%), type-2 diabetes (35-37%). Total healthcare costs increased significantly from pre-index to post-index periods for all criteria. Using C1, healthcare costs increased from $28,983 to $39,658, indicating a 37% rise, with development of F3/F4. Likewise, total healthcare costs after developing F3 and F4 via C2-C3 criteria increased by 11-26% and 47-48%, respectively. The annual mean number of ambulatory visits for F3/F4, F3, and F4 using all criteria indicated a 26%, 21-26% and 29-34% significant increase. Conclusion: NAFLD/NASH patients experienced an increase in healthcare costs (11-48%) post the development of advanced fibrosis. Estimating fibrosis stage using the FIB-4 score categories of varying sensitivity and specificity allows for additional insights to assess economic and clinical burden associated with development of advanced fibrosis in NAFLD/NASH. (Table Presented).



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