Statistics show approximately 15 million Americans suffer from NASH, a nonalcoholic fatty liver disease that is projected to become the most common reason for liver transplantation. There are no FDA approved therapies for NASH, so doctors are forced to treat patients with off-label medications while keeping an eye out for breakthroughs in medication development.

Two novel therapies, obeticholic acid and elafibranor, are currently in Phase III trials. If they receive FDA approval, interest will be high as they will be the first treatments specifically labeled for NASH. We detail a budget impact model for a sample state Medicaid plan in this poster presentation. This activity is valuable for payers to anticipate the impact of cutting-edge therapies in their population and proactively plan management strategies that ensure member access while maintaining cost-effectiveness. This presentation was given at the American Drug Utilization Review Society (ADURS) conference February 22-24, 2018 in Scottsdale, Arizona.