MARKET OUTLOOK

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.

QUESTIONS ANSWERED

  • 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?

PRODUCT DESCRIPTION

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.

GEOGRAPHY

France, Germany, Italy, Spain, UK

PRIMARY RESEARCH

  • 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)

KEY DRUGS COVERED

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

CONTENT HIGHLIGHTS

  • 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

  • Nonalcoholic Steatohepatitis - Access & Reimbursement - Detailed, Expanded Analysis - Top 5 European Markets

Author(s): Yulia Privolnev, MA; Tim Blackstock, MB, ChB, MPhil

Yulia Privolnev is a manager on the Global Market Access Insights team at Decision Resources Group, primarily focusing on European market access. She is responsible for monitoring, analyzing, and reporting on global market access through the production of DRG’s Global Market Access Solution (GMAS) and Access & Reimbursement products. Yulia’s specific focus is on all aspects of market access in Western and Eastern Europe, as well as external reference pricing (ERP) and managed entry agreements (MEAs) on a global scale. Yulia 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., is a Director in Decision Resources Group’s Cardiovascular, Metabolic, Renal and Hematologic Disorders team focusing on dyslipidemia, 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, as well as overseeing the work of team analysts across various metabolic and renal indications.

Tim holds a bachelor degrees in medicine and surgery from the University of Otago, New Zealand, and practiced medicine for five years, rotating through various specialties, including internal medicine, general surgery, and psychiatry. Prior to joining DRG, he was a writer in the medical communications industry, developing content for various media, as well as providing editorial assistance to leading pharmaceutical companies and medical experts across a variety of therapeutic areas.