BURLINGTON, Mass., Nov. 11, 2015 /PRNewswire/ -- Decision Resources Group finds that the lack of a simple diagnostic test and low physician awareness coupled with the lack of therapeutics are all contributing to underdiagnosis of nonalcoholic steatohepatitis (NASH). Our study estimates the prevalence of NASH to be four to ten percent in major markets under study, including U.S., Germany, France, Spain, Italy, and U.K., fueled in large part by the current obesity epidemic. Tremendous unmet need exists for NASH therapies in developed markets, particularly among patients with advanced liver disease, driven in part by a large patient population that is further anticipated to grow due to aging. Currently, a hefty pharmaceutical pipeline of NASH therapeutics is progressing through clinical trials. However, our research reveals that only patients with advanced liver disease are likely to be treated with emerging agents.
Other key findings from Special Report entitled "Nonalcoholic Steatohepatitis":
- Diagnosed prevalence of NASH will increase slowly through 2024 in markets under study, owing to population growth and/or aging and increasing physician awareness, driven in part by the anticipated launches of novel therapeutics and new diagnostics.
- Upon launch, we expect that the availability of Intercept's obeticholic acid (OCA) and Genfit's elafibranor will see rapid uptake, as there are currently no approved therapies for NASH. Interviewed thought leaders agree that these agents appear to offer similar clinical efficacy. Hence, prescribing decisions will be primarily driven by safety and tolerability profiles, and payer dynamics.
- Substantial data and expert opinion support both lifestyle intervention, such as diet modification and exercise, and high-dose vitamin E as providing benefit in NASH. Since these approaches, together or separately, are extremely inexpensive, payers may impose step-therapy restrictions and require implementing these low-cost options before initiating pharmacotherapy, limiting the potential drug-treated population. As lifestyle modification and vitamin E provide little benefit in patients with advanced disease, emerging pharmaceutical agent use may be reserved for patients with significant hepatic injury.
Comments from Decision Resources Business Insights Analyst Michael Breen, Ph.D.:
- "While NASH itself is a liver disease, its development and progression are likely influenced by multiple organs or systems. The best therapeutic for NASH may address a non-specific issue systemically, such as inflammation or insulin resistance, or may directly affect another tissue, such as muscle, with secondary effects on liver disease. The fact that NASH may be treatable via multiple mechanisms, along with the magnitude of the market opportunity, suggests there will be intense competition from numerous drug developers in this space."
- "There are several lessons to be learned so far from clinical trials in NASH. Patients with less severe disease show high rates of spontaneous improvement, which can skew trial data and make results difficult to interpret. End points such as changes in NASH activity score (NAS), and particularly improvements in fibrosis, will be the standard going forward. Looking at a single end point, such as steatosis, or enrolling patients with mild disease will likely not be sufficient to demonstrate enough clinical benefit to compete with the widening field of potential NASH agents."
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Decision Resources Group offers best-in-class, high-value data, analytics and insights products and services to the healthcare industry, delivered by more than 900 employees across 14 global locations. DRG provides the pharmaceutical, biotech, medical device, financial services and payer industries with the tools, insights and advice they need to compete and thrive in an increasingly complex and value-based marketplace. DecisionResourcesGroup.com.
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