Interventions of Interest:
- resmetirom (Madrigal Pharmaceuticals, Inc.)
- obeticholic acid (Ocaliva or “OCA”, Intercept Pharmaceuticals)
An independent appraisal committee narrowly voted that currently available evidence for resmetirom is adequate to demonstrate a net health benefit over lifestyle management, whereas current evidence for obeticholic acid was deemed inadequate to demonstrate a net health benefit.
ICER analyses suggest resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year assuming that short-term effects on liver fibrosis translate into longer-term reductions in cirrhosis; under the same assumptions, obeticholic acid would achieve common thresholds for cost-effectiveness if priced between $32,600 – $40,400 per year.
ICER’s Chief Medical Officer David Rind, MD stated:
“NASH is increasingly common and lacks good therapies. While many with NASH will remain asymptomatic, some individuals will progress to severe liver disease and experience the complications of cirrhosis, hepatocellular cancer, and/or require liver transplantation. NASH is also a marker for increased cardiovascular risk and one of these therapies, resmetirom, improves lipids, while the other therapy, obeticholic acid, worsens lipids and also causes itching in many patients. If these drugs receive FDA approval, while awaiting long-term liver and cardiovascular data, patients and doctors will need to balance the risks, burdens, and potential benefits of each of these therapies.”