Budget Impact Analysis of Noninvasive Tests Strategies for Metabolic Dysfunction-Associated Steatohepatitis (MASH) Diagnosis in Japan

Author(s)

Yoshio Sumida, PhD1, Satoko Matsukawa, PhD2, Akshay Chauhan, MPH3, Hiroyuki Matsuda, DrPH, MSc4.
1Graduate School of Healthcare Management, International University of Healthcare and Welfare, Tokyo, Japan, 2Novonordisk Pharma, Ltd., Tokyo, Japan, 3IQVIA India, Mumbai, India, 4IQVIA Solutions Japan G.K., Tokyo, Japan.
OBJECTIVES: In the evaluation of Metabolic Dysfunction-Associated Steatohepatitis (MASH), non-invasive tests (NITs) have been intensively investigated to address the challenges associated with liver biopsy such as expensiveness and invasiveness. This study aims to compare the diagnosis cost and one-year lifetime liver disease management costs in Japan between intervention (diagnosing with NITs only) versus comparator (diagnosing with liver biopsy following NITs screening).
METHODS: Following ISPOR guidelines on good practices for BIA (2007), diagnosis costs and one-year lifetime liver disease management costs were computed for approximately 540,000 MASH prevalence in Japan, using a decision tree followed by a Markov model. The decision tree classified subjects into either less advanced (≤F2) or advanced (≥F3) liver disease categories based on the sensitivity and specificity of NITs as reported in previous studies. Liver biopsy was assumed to be 100% accurate. Diagnosed patients then transitioned to a Markov model, wherein liver disease management costs were incurred according to their health states as they progressed through the Markov cycles.
Three NITs scenarios were considered: FIB-4 combined with Type IV collagen 7S (T4C7S), a reimbursed diagnosis testing in Japan, for base case; FIB-4 combined with ELF and VCTE for alternative 1; FIB-4 combined with T4C7S and VCTE for alternative 2.
RESULTS: The use of NITs was cost-saving than comparator in all NIT scenarios despite the unnecessary management cost incurred by higher number of patients with ≤F2 misclassified as ≥F3. In base case, intervention resulted in reduction in the total of diagnosis cost and one-year lifetime liver disease management costs by ¥8.19 billion per Japanese population of 124 million than comparator.
CONCLUSIONS: It was demonstrated that diagnosing with NIT only costs less than NITs followed by liver biopsy confirmation. NITs can be considered to be a good alternative to liver biopsy.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

EE91

Topic

Economic Evaluation, Medical Technologies, Patient-Centered Research

Topic Subcategory

Budget Impact Analysis

Disease

Diabetes/Endocrine/Metabolic Disorders (including obesity), No Additional Disease & Conditions/Specialized Treatment Areas

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