Introduction: NASH is characterized by a buildup of excess lipid (steatosis) in the liver, resulting in inflammation and eventually liver damage, leading to fibrosis and subsequently cirrhosis and putting patients at risk of liver failure and hepatocellular carcinoma. Despite a major unmet need, there are currently no drugs approved for the treatment of NASH in any market. As a consequence, the only treatment options available are off-label therapies, typically confined to inexpensive generic drugs that have little evidence as effective treatment of NASH. With four compounds in Phase III trials and numerous drugs in Phase II development, the odds are high that there will be several launches in this space over the next decade. However, novel NASH agents will likely face significant market access challenges, as MCOs look to minimize the impact of NASH treatment on their budgets.

Questions Answered in This Report

  • How do payers anticipate reimbursing emerging therapies for NASH, such as Intercept’s Ocaliva or Genfit’s elafibranor, post-approval? What restrictions will they impose?
  • What are physicians’ opinions on current late-phase emerging therapies (Intercept’s Ocaliva, Genfit’s elafibranor, Allergan’s cenicriviroc, and Gilead’s selonsertib)?
  • How do payers reimburse current diagnostic tests, such as liver biopsy, in 2018? What role will diagnostic tests play in the prescribing of emerging therapies?
  • What role do reimbursement, restriction, and patient cost play in physicians’ decisions to prescribe therapies for NASH?

Scope:

  • Markets covered: United States.
  • Methodology: Survey of 27 hepatologists and 73 gastroenterologists in the United States in addition to 30 U.S. managed care organization (MCO) pharmacy and medical directors (PDs/MDs).
  • Indication coverage: non-alcoholic steatohepatitis (NASH).
  • Key drugs covered: Ocaliva (obeticholic acid), elafibranor, cenicriviroc, selonsertib, vitamin E, pioglitazone, ursodiol, statins, ezetimibe, metformin, SGLT-2 inhibitors, GLP-1 receptor agonists.
  • Key companies mentioned: Intercept Pharmaceuticals, Genfit, Allergan, Gilead Sciences.

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