Challenging the status quo in NASH

October 11, 2018
Mark DeLegge, Senior Medical Director and Strategy Lead, NASH Center of Excellence

By 2020 NASH will be the leading cause for liver transplantation globally. IQVIA’s NASH Center of Excellence offers solutions to accelerate the development of treatment options.

Pharma companies looking for new opportunities to develop drugs for unmet medical needs are increasingly drawn to patients with non-alcoholic steatohepatits (NASH). NASH is the severe form of non-alcoholic fatty liver disease (NAFLD), in which fat builds-up in the liver causing inflammation, fibrosis, cirrhosis and liver cancer. It is a growing medical concern in the US and abroad.

However, stratifying and referring the right patients for clinical trials is a challenge. IQVIA internal analysis shows the average rate of enrollment for NASH studies in the US and Europe is just 0.4 patients per site, per month, which translates to huge time and cost challenges.

Currently there are no treatment options beyond diet and exercise. While the exact cause of NASH isn’t clear, it is more common among people with type-2 diabetes and obesity. As the numbers of people with these conditions increase so too will the rate of patients suffering from NASH, creating heavy consequences on healthcare systems. It’s also driving multiple pharmaceutical manufacturers to pursue novel treatments for this unmet medical need. The therapeutic market for NASH is currently estimated to reach $35-40 billion by 2025, with dozens of drugs currently in development, and several already heading into phase III studies.

Unfortunately, the only definitive diagnostic tool for NASH is a liver biopsy. Other non-invasive biomarkers supporting a NASH diagnosis, such as a blood test or an MRI scan, are not conclusive enough to make a definitive diagnosis. Due to a lack of awareness and treatment options physicians are currently reluctant to pursue a painful and costly liver biopsy. This reluctance is compounded by the fact that more than half of liver biopsies performed on suspected NASH patients ultimately have negative results, according to IQVIA.

Other important factors impacting clinical trial recruitment in this area include:

  • NASH is generally an asymptomatic disease until late.
  • Patients have a lack of awareness of the disease.
  • Many physicians caring for NASH patients are unfamiliar with the disease and its consequences.

All of these challenges are converging to make NASH clinical trials uniquely difficult to deliver.

New Solutions to NASH’s challenging questions

To change the paradigm in NASH a new approach is needed. Tapping advanced analytics and innovative diagnostics to identify undiagnosed patients. Educating providers and patient advocacy groups about risk factors and warning signs. Supporting trial sites in new, more proactive ways. Embracing real-world evidence to better assess risk, and create market access and reimbursement strategies that make sense for NASH and the patients it affects.

In response, IQVIA’s NASH Center of Excellence is leveraging the IQVIA CORE™ to develop innovative data analytics and delivery models for complex clinical trial patient recruitment. Unparalleled data assets allow us to accelerate the identification and treatment of undiagnosed patients, and predictive analytics and algorithms help identify risk factors among NASH patients and define the patient recruitment funnel. Our Integrated NASH Site Network (INN ) then links patients and referral practices to the investigative sites in a seamless fashion.

IQVIA has also spent the last few years researching more innovative, non-invasive diagnostic options, including blood tests, imaging, and probes that measure the condition of the liver non-invasively using sound waves. Through collaborations with imaging and serum biomarker companies, IQVIA can predict the presence of fibrosis, steatosis (e.g., fat) and inflammation non-invasively. Advances in this space offer hope that less invasive tools will soon be approved for diagnosing NASH patients and to confirm trial participation.

Recruiting patients for NASH trials will always be challenging, but by constantly challenging the status quo, and by being creative in building the right network model, better education programs, data-driven recruiting strategies, and more innovative diagnostic tools, IQVIA is leading the way toward new solutions.

To learn more about NASH, read a recent 2-part series from IQVIA’s Senior Medical Director and Strategy Lead in the NASH Center of Excellence:

And to dive into how IQVIA is leveraging the CORE™ to develop innovative analytic and technology-driven solutions to helping customer navigate the NASH landscape (both before and after approval).

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