System-Level Barriers and Evidence Gaps in the Adoption of Emerging MASH Therapies

The panelist examined the key obstacles to MASH therapy adoption at the system level, with Dr. Behari identifying patient identification as the most critical challenge and outlining a two-step risk stratification pathway — beginning with the Fibrosis 4 (FIB-4) Index, a readily calculable score that can be integrated into electronic health record (EHR) systems to triage low-risk patients away from subspecialty referral, followed by transient elastography for higher-risk patients, a technology that remains unevenly distributed across health systems and largely inaccessible to patients in rural or smaller community settings. Dr. Behari then addressed the evidence required for formulary adoption of the two conditionally approved MASH therapies, noting that final FDA approval awaits hard clinical endpoint data demonstrating reductions in liver decompensation, liver cancer, need for transplantation, and death, and that additional evidence is needed around competing risks in patients with advanced comorbidities such as heart failure or chronic kidney disease (CKD), where treating liver disease with expensive therapies may not be cost-effective. He also highlighted the emerging importance of multi-target therapy evidence, pointing to tirzepatide as an example of a glucagon-like peptide-1 (GLP-1) receptor agonist with potential benefits across obesity, type 2 diabetes, and MASH simultaneously, and emphasized that demonstrating cost-effectiveness in patients with metabolic multimorbidity will be a critical evidence priority at the population level.

Throughout the conversation, the expert provided a comprehensive reflection on the field and the factors that may shape how clinicians approach care moving forward.

The next episode in this series, 'Improving Coverage and Multidisciplinary Care Delivery for MASH,' features the panelists advancing their conversation on metabolic dysfunction-associated steatohepatitis and focusing on systems-level strategies to improve insurance coverage readiness for new MASH therapies and the broader health system transformations needed to sustain scalable, multidisciplinary MASH care.