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.

Table of contents

  • Nonalcoholic Steatohepatitis - Access & Reimbursement - Detailed, Expanded Analysis (US)
    • A & R - Non-alcoholic Steatohepatitis (US)

Author(s): Andrew Frost ; Chris Lewis

Andrew Frost is a Business Insights Analyst in Decision Resources Group’s Cardiovascular, Metabolic, Renal, and Hematologic Disorders team focusing on obesity and non-alcoholic steatohepatitis (NASH). In this role, he evaluates the latest primary and secondary research, as well as available commercial information, to forecast the potential of developmental drugs and provide insight on the various dynamics affecting relevant markets. Prior to joining DRG, Andrew worked as a Senior Drug Analyst at Citeline in the Cardiovascular and Metabolic Team. Andrew holds a BSc (Hons) degree in Pharmacology, awarded by King’s College London, and he has previously worked in the Immunopharmacology team at UCB.

 

Chris Lewis serves as primary research manager, U.S. Access and Reimbursement, with responsibility for coordination, content review and content generation of the market access and reimbursement insights at DRG. Content is based on online surveys of managed care organizations and physicians and expert analysis of reimbursement and prescribing patterns of key therapies treating various disease states.

Lewis was an analyst/senior analyst for the group’s HealthLeaders-InterStudy subsidiary for eight years, specializing in the managed care and pharmacy benefit management industries. Throughout her tenure, she has produced the Health Plan Analysis reports for California, New York, New Jersey, Connecticut, and Pennsylvania and authored DRG’s series of pharmacy benefit manager profiles. She has also conducted numerous webinars for the group. She is a seasoned journalist with a B.A. in communications from California State University, Sacramento.