Non-Invasive Tests (NITs) to Risk-Stratify Patients with Noncirrhotic Metabolic-Associated Steatohepatitis (MASH) in a Specialty Setting Eligible for Resmetirom: A Cost-Effectiveness Analysis from a U.S. Payer Perspective
Moderator
Yestle Kim, MSc, PharmD, Madrigal Pharmaceuticals, Jersey City, NJ, United States
Speakers
John O'Donnell, MPP, PhD; Melissa Gomez Montero, MSc, Optimax access, Netherlands; Mehdi Javanbakht, MSc, PhD; Suneil Hosmane; Amir Ansaripour
OBJECTIVES: NITs are crucial for identifying patients eligible for resmetirom. Accurate diagnosis of patients with F2-F3 non-cirrhotic MASH is essential for optimizing patient outcomes and resource allocation. This study assessed and compared the cost-effectiveness and accuracy of two diagnostic strategies: (1) two sequential NITs, and (2) the same NIT sequence followed by liver biopsy (LB) for discordant cases, reflecting clinical practice in specialty care.
METHODS: A cost-utility analysis combined a decision tree for diagnostic pathways with a Markov model to evaluate long-term cost-effectiveness of resmetirom treatment compared with placebo over a lifetime horizon, using a willingness-to-pay threshold of $100,000 per quality-adjusted life-year. Two-step NIT sequences, defined by pre-specified cut-off thresholds, were modeled: the first NIT identified significant MASH fibrosis (F≥2), and the second NIT ruled out cirrhosis (F4). Three categories of NITs (blood-based, imaging-based, and combined modalities) were assessed, yielding 57 combinations. The model simulated patients referred to specialty care for suspected non-alcoholic fatty liver disease, with or without fibrosis.
RESULTS: The most accurate NIT combinations in each category were: enhanced liver fibrosis (ELF) using two cutoffs of ≥8.8 for NIT1 and ≥11.3 for NIT2 (blood-based); transient elastography (TE) ≥8kPa followed by magnetic resonance elastography (MRE) ≥4.7kPa (imaging-based); and ELF ≥8.8, followed by MRE ≥4.7kPa (blood-imaging). Among these strategies, the imaging-based combination using TE ≥8kPa and MRE ≥4.7kPa demonstrated the highest net monetary benefit of $2,358, making it the most cost-effective approach, compared with the same respective sequence followed by LB for discordant cases.
CONCLUSIONS: This modeling study demonstrates that imaging-based NITs without LB offer the most cost-effective approach for diagnosing F2-F3 MASH in the US, while enhancing diagnostic efficiency and reducing reliance on invasive and costly LBs. These findings highlight the value of integrating NIT-only strategies to enhance access to emerging therapies, support payer value, and optimize healthcare resources.
METHODS: A cost-utility analysis combined a decision tree for diagnostic pathways with a Markov model to evaluate long-term cost-effectiveness of resmetirom treatment compared with placebo over a lifetime horizon, using a willingness-to-pay threshold of $100,000 per quality-adjusted life-year. Two-step NIT sequences, defined by pre-specified cut-off thresholds, were modeled: the first NIT identified significant MASH fibrosis (F≥2), and the second NIT ruled out cirrhosis (F4). Three categories of NITs (blood-based, imaging-based, and combined modalities) were assessed, yielding 57 combinations. The model simulated patients referred to specialty care for suspected non-alcoholic fatty liver disease, with or without fibrosis.
RESULTS: The most accurate NIT combinations in each category were: enhanced liver fibrosis (ELF) using two cutoffs of ≥8.8 for NIT1 and ≥11.3 for NIT2 (blood-based); transient elastography (TE) ≥8kPa followed by magnetic resonance elastography (MRE) ≥4.7kPa (imaging-based); and ELF ≥8.8, followed by MRE ≥4.7kPa (blood-imaging). Among these strategies, the imaging-based combination using TE ≥8kPa and MRE ≥4.7kPa demonstrated the highest net monetary benefit of $2,358, making it the most cost-effective approach, compared with the same respective sequence followed by LB for discordant cases.
CONCLUSIONS: This modeling study demonstrates that imaging-based NITs without LB offer the most cost-effective approach for diagnosing F2-F3 MASH in the US, while enhancing diagnostic efficiency and reducing reliance on invasive and costly LBs. These findings highlight the value of integrating NIT-only strategies to enhance access to emerging therapies, support payer value, and optimize healthcare resources.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EE209
Topic
Economic Evaluation
Disease
SDC: Gastrointestinal Disorders