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

26 May 2023

When the first non-alcoholic steatohepatitis drugs reach market, the health cost watchdog says payers will be justified in setting step-therapy including weight-management efforts, while early prescribing should be by specialists.

Cost control — ICER report recommends step therapy when NASH drugs reach market • Source: Shutterstock

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...