ICER’s Final NASH Report Urges Step Therapy, Specialist Prescribing, Equitable Access

The final assessment from the US Institute for Clinical and Economic Review (ICER) on the first drugs vying to open the market for non-alcoholic steatohepatitis (NASH), Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) and Madrigal Pharmaceuticals, Inc.’s resmetirom, concludes that payers should consider using step therapy for weight management before NASH drugs, that price-volume and outcomes-based agreements may be suitable for pricing the first NASH drugs to reach market, and that coverage criteria should foster equitable access to therapy.

The final report issued 25 May follows a draft report issued in February and a public hearing of ICER’s Midwest Comparative Effectiveness Public Advisory Council on 28 April that determined that resmetirom, an oral THRβ agonist, appears to offer cost-saving potential to the US health care system in NASH, an asymptomatic and slow-developing liver disease that can advance to liver failure and the need for transplantation