Non-alcoholic steatohepatitis (NASH) is rapidly becoming an important public health issue in the top five European markets (France, Germany, Italy, Spain, UK). High prevalence of this multifaceted disease, coupled with a lack of approved pharmacotherapy and novel diagnostics on the horizon, presents a huge opportunity for drug manufacturers. With five agents currently in Phase III trials, and numerous products undergoing Phase II development, a number of highly anticipated launches are likely in the next decade. However, the potential cost of such a drug market will have a substantial impact on the tight healthcare budgets in Europe, such that payers will have to be convinced of the cost-effectiveness of treatments, and manufacturers may have to consider savvy pricing strategies. This research analyzes payer and prescriber perspectives on near-term emerging therapies for NASH, focusing on HTA considerations, reimbursement drivers, product positioning, and uptake potential.


  • What is the current treatment approach for NASH in the top European markets, and how, if at all, is this impacted by payer policy?
  • To what extent are off-label therapies used for NASH? How do payers reimburse and control any such off-label prescribing? How does this vary between and within the countries under study?
  • What are payer and prescriber perspectives on promising, but costly emerging agents such as Ocaliva? Do they consider the clinical benefit of these products to be worthy of premium price tags?
  • What key market access challenges will manufacturers of novel NASH therapies face? What can they do to encourage optimal pricing and reimbursement terms, and to drive uptake?


European Access & Reimbursement provides integrated brand-level and country-specific analysis of primary market research conducted with payers and prescribers examining reimbursement dynamics and evaluating the impact of payer policy on prescribing behavior.


France, Germany, Italy, Spain, UK


  • Survey of 250 hepatologists and gastroenterologists across the top 5 European markets (50 per country)
  • Interviews with 10 payers across the top 5 European markets (2 per country)


Ocaliva, elafibranor, cenicriviroc, selonsertib, vitamin E, pioglitazone, ursodiol, statins, ezetimibe, metformin, SGLT-2 inhibitors, GLP-1 receptor agonists.


  • Actionable recommendations to optimize market access
  • Market access success and stumbles
  • Market access roadblocks
  • Pricing and reimbursement dynamics
  • Impact of payer policy and coverage on prescribing
  • Market access outlook for emerging therapies

Table of contents

  • Non-Alcoholic Steatohepatitis - Access & Reimbursement - Detailed, Expanded Analysis - Top 5 European Markets
    • Access & Reimbursement - NASH - EU - December 2019

Author(s): Yulia Privolnev, M.A.; Tim Blackstock, M.B., Ch.B., M.Phil.

Yulia Privolnev, M.A., is a manager on the Global Market Access Insights team at DRG, part of Clarivate. She focuses on European market access. She holds a bachelor’s degree from the University of Toronto and a master’s degree from the London School of Economics.

Tim Blackstock, M.B. Ch.B., M.Phil., is a senior director on the Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders team at Clarivate. He has authored numerous reports focusing on metabolic indications, chiefly dyslipidemia, obesity, and nonalcoholic steatohepatitis (NASH), and has expertise in renal disorders and hemophilia. He has collaborated extensively with Clarivate’s Real World Data and Analytics team to provide expert analysis and advice, particularly related to NASH projects. Previously, Dr. Blackstock worked in the medical communications industry, providing scientific writing and editorial assistance to leading pharmaceutical companies in a variety of therapeutic areas. He holds bachelor degrees in medicine and surgery from the University of Otago in New Zealand and practiced medicine for five years, rotating through various specialties, including internal medicine, general surgery, and psychiatry.