The Dash to Treat NASH, Looking Toward the Finish Line


  • David J. Lomb, PhD, Associate Principal, Defined Health
  • Brent Osborne, PhD, Senior Consultant, Defined Health


  • Manal Abdelmalek MD, MPH, Duke University
  • Roger Longman, Real Endpoints

With an estimated 18-30 million adults affected in the U.S. alone and no FDA approved treatments, non-alcoholic steatohepatitis (NASH) has been proclaimed “the Next Big Global Epidemic” and “the Next Hepatitis C.” Indeed, analysts have forecast that the market for NASH drugs could reach $35-40 Billion by 2025.  The sheer magnitude of this opportunity has not been lost on investors or the Biotech/Pharma community, and NASH has rapidly become a crowded space in which to play.  There are now nearly 200 assets in development for NASH, a few of which have pivotal Phase III trials well underway (e.g., Intercept’s OCA, Genfit’s elafibranor). NASH undoubtedly represents an untapped market with blockbuster commercial potential, but analysts and drug developers alike will need to grapple with at least two factors that could prevent the industry from realizing the full potential of this market:

  1. The size of the addressable patient population may actually be much smaller than population-based studies would suggest, at least until better methods of identifying and diagnosing NASH patients are implemented, and,
  2. Pushback from payers may limit access to drugs for NASH, unless developers can demonstrate that treatment improves patient outcomes.

Accordingly, accurate assessment of the commercial potential of any new drug for NASH requires consideration of a number of essential questions:

  • What will a label indication for NASH look like?
  • How will clinicians identify NASH patients and decide which patients to treat?
  • What criteria will payers use to determine eligibility for reimbursement?
  • How will the pricing of drugs for NASH influence market access and reimbursement?
  • Once multiple drugs are approved, how will payers manage access to combination therapies?

In this webinar, David J. Lomb, PhD, and Brent Osborne, PhD lead a conversation with Manal Abdelmalek MD, MPH (Duke University) and Roger Longman (Real Endpoints) to discuss the impact of these and other questions on the clinical, regulatory and commercial prospects for new products being developed for NASH, and what this means for the stakeholders interested in investing in these therapies.