OBJECTIVES: There are no drugs approved for the treatment of NASH. The current treatments, such as lifestyle modification, have limitations. As a result, there is a well-defined patient population with an unmet need. Biopharmaceutical manufacturers have responded with 43 drugs for NASH in clinical development. The NASH market has been estimated at $25B by 2026. The purpose of this research is to understand how US payers are planning to manage the influx of promising specialty NASH products and their expected data requirements.

METHODS: This study used primary and secondary research. Subjects included 25 US payers employed by a private or public insurer. To gain payer insights, we conducted a mix of 20 online survey, advisory board, and five telephone interviews. Targeted literature search was conducted. All data and information were tabulated and analyzed.

RESULTS: The research identified NASH as a topic of great interest and importance, driven by cost concerns. To manage the cost, payers will rely heavily on utilization management, with prior authorization as the primary restriction. One of the prior authorization criteria will likely be a confirmed NASH diagnosis, with Fibroscan being the preferred diagnostic tool. A phase III study demonstrating significant incremental benefit over a combination therapy, such as lifestyle management, is the payer’s preference. Payers are also looking for cost-related information, in particular, cost offset data. Diabetes, hypertension, and hepatitis C were analogues payers referenced. The likelihood of a formulary with a preferred product in the NASH class or by the mechanism of action was mixed. Discounts and rebates are the preferred contract types.

CONCLUSIONS: There is an enormous opportunity for manufacturers to address an unmet need for patients with NASH. It will be critical for biopharmaceutical manufacturers to develop and execute a robust evidence plan and payer strategy to meet the payer’s needs.