NASH News January 2021
Global Liver Institute Releases U.S. NASH Action Plan
2021 is already proving itself to be a year of action. While the world adjusted, innovated and rose to the challenge of fighting a global pandemic in 2020, this coming year will be one in which solid planning and determination coalesce to drive results that save lives — not just delivery of vaccines for COVID-19 but also for treatment and care for patients with NASH.
We are pleased to start this year with the U.S. NASH Action Plan, developed by GLI and the GLI NASH Council, to comprehensively address NASH and its impact on patients and families, public health, and the economy. Our new plan includes a set of actionable recommendations for the full spectrum of groups involved in NASH prevention and treatment, including: patients and caregivers, clinicians, patient advocacy organizations, medical societies, industry, policymakers, regulators, health systems, and health insurance payers. I encourage you to thoroughly read the plan, learn how you can contribute, and commit to taking action in 2021.
Recommendations from the U.S. NASH Action Plan for GLI NASH Council members and the larger health community include:
Education increasingly tailored for at-risk patient populations, in-language and in-culture.
Updated guidelines for standards of care and coordinated care pathways.
Adoption and reimbursement of non-invasive diagnostics.
Payor and health system research on patient-centric value-based care and benefit design.
Integration of NASH into public health, regulatory, and legislative priorities.
This year, through working together in a strategic way, we can reduce the prevalence of NASH and improve outcomes for patients living with this disease. Please join us and the full liver community as we take coordinated action and make 2021 the year of results.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
GLI Updates
2020: A Year of Growth for GLI NASH Programs
As communities around the world continue to fight COVID-19 and prevent additional waves, our cities and towns are also increasingly battling the NAFLD and NASH epidemic. NASH is a global public health challenge that is only increasing in prevalence and GLI is dedicated to turning that tide. This year’s heightened focus on healthcare has provided an opportunity for the liver health community to work more collaboratively across specialty areas to examine how countries are addressing NAFLD and NASH. Thus, even in a year of great challenge, GLI has made large strides in our work to increase awareness, diagnostic options, and treatments for NASH. Read about the accomplishments of GLI’s NASH programs in 2020.
Development of a Patient-Reported Outcome Measure for Non-Alcoholic Steatohepatitis (NASH-CHECK): Results of a Qualitative Study
GLI President and CEO Donna Cryer is a co-author on a new study shared in December 2020 in The Patient - Patient-Centered Outcomes Research. The study aimed to develop a NASH-specific patient-reported outcome measure (NASH-CHECK) for use as a trial endpoint, using methods compliant with regulatory expectations. Interviews conducted as part of the study revealed key symptoms and broad health-related quality of life impacts of NASH. Read the research article.
GLI Engagement at The Liver Meeting
GLI brought the patient perspective to the digital forefront during The Liver Meeting Digital Experience (TLMdX) held by the American Association for the Study of Liver Diseases (AASLD) November 13-16, 2020. As part of their new strategic plan, AASLD has committed to actively engage with patients, and GLI staff highlighted the important role GLI has to play in implementing this strategy, in addition to sharing our advocacy work and goals:
As a member of the Inaugural Patient Advisory Committee, Donna Cryer participated in an interactive Meet and Greet between committee members and the hepatology community.
Andrew Scott, GLI Director of Policy, spoke about best practices in liver health advocacy and opportunities to participate in liver health advocacy with Congress, the U.S. Food and Drug Administration, and the Centers for Medicare & Medicaid Services.
Donna co-moderated presentations of key public health, health equity, and healthcare delivery posters through an Interactive Patient-Focused Abstract Tour.
Donna also co-moderated the AASLD Annual Patients Forum, which included patient advocacy organization leaders and focused on patient engagement achievements and future areas for collaboration.
GLI applauds AASLD for committing to active patient engagement and holding forums for interactive discussions. Read some of the key takeaways that stood out for GLI staff members.
GLI and the NASH Care Act of 2020
In October, Congressman Dan Crenshaw (R-TX) and Congressman Raul Ruiz (D-CA) introduced the Nonalcoholic Steatohepatitis Care Act of 2020. This bill would establish a national strategy for preventing, diagnosing, and treating NASH. Read our full statement on this important legislation.
Over the years, whether it is through the NASH Council or through specific initiatives like International NASH Day and the U.S. NASH Action Plan, GLI and many in the NASH community have advocated for a greater national priority on NASH. As we start 2021 and a new Congressional term, we look forward to working with Reps. Crenshaw and Ruiz to reintroduce this critical piece of legislation.
GLI and Partners Receive Educational Grant from Pfizer
We are pleased to share that GLI, Albert Einstein College of Medicine-Montefiore Medical Center - Center for Continuing Professional Development, and Integritas Communications have received an educational grant from Pfizer, to execute the 2021 Nonalcoholic Steatohepatitis (NASH) Diagnostics Forum™.
The initiative, titled “A Critical Appraisal of Noninvasive Technologies in NASH: Informing the Future of NASH Diagnosis and Assessment,” will convene a multidisciplinary panel of experts to conduct a comprehensive analysis of available data on non-invasive biomarkers and tools for diagnosis, prognosis, and monitoring of NASH. The grant will also support dissemination of the Forum’s findings to the broader medical community via multiple media, including a CME/CE-certified webcast. Read more in our joint announcement.
GLI Launches the Pediatric and Rare Liver Diseases Council
GLI’s Pediatric and Rare Liver Diseases Council (PRLDC) brings together non-profit, industry, government, and patient representatives who are committed to addressing the challenges and impact of pediatric and rare liver diseases on individuals, communities, and organizations around the world. The Council held its inaugural meeting on November 18 and discussed pediatric NASH among a number of topics. Gina Villiotti Madison, Executive Director of NASH kNOWledge, was named Co-Chair for the PRLDC Education Working Group. Read more information.
Editorial By Donna Cryer – “NASH: Connecting the dots with patients in mind”
An editorial from Donna Cryer was recently published in Volume 3, Issue 4 of the journal, Endocrinology, Diabetes & Metabolism, released by Wiley Online Library. “Connecting patients to their sense of self‐efficacy and their communities is essential to defeating NASH,” shared Donna. Read the full editorial about the connections that patients, primary care providers, specialists, policymakers, and advocacy organizations around the world can make to address the NASH epidemic.
Beyond the Biopsy: Summary of September 2020 Report
GLI launched the Beyond the Biopsy initiative in September to promote awareness and education about the use of non-invasive diagnostics as an alternative to biopsies. The initiative encourages advocates to support greater adoption of non-invasive diagnostics by directly influencing legislative, regulatory, and coverage/reimbursement changes. The launch of the initiative included a national radio tour and virtual panels focusing on three states (Colorado, Massachusetts, and New York) with leading experts, policymakers, and patient advocates featured as speakers. Read more about the launch of Beyond the Biopsy in our Summary Report of September 2020 (PDF) and stay tuned for more developments.
Ensure Your Colleagues Stay Informed in 2021
With life moving more virtual and inboxes flooded with emails, it’s more important than ever to get the information you need in a clear and comprehensive format. GLI’s NASH News pulls together the most up-to-date information on GLI initiatives, research & development, lifestyle interventions, and clinical care. Make sure your colleagues stay informed by sharing their email addresses (with their permission, of course) with Whitney Gray, NASH Communications Manager.
Upcoming Events
February 4 - NASH Council Policy Working Group. Contact Andrew Scott for more information.
February TBD - 2021 NASH Diagnostics Forum™. Invitation-only event for a multidisciplinary panel of experts. Learn more.
May TBD - Full NASH Council Meeting. Contact NASH@globalliver.org for more information.
June 10 - International NASH Day. Contact Livia Alimena to become a partner or Richard Gelula for sponsorship information.
September 20-24 - Advanced Advocacy Academy. Contact Jen DelGrande for more information.
Patient Perspective
Pediatric NASH
A woman from Vienna, Austria, shared her story with GLI on her 10-year-old grandson’s journey with NAFLD. Read her full story here in German and English and an excerpt below:
“I have a grandson whom I unfortunately only met a year ago. I was happy that my family was reunited. However, when I first saw him, I was in shock. My grandson is 10 years old and has been nourished incorrectly from the pediatrician since birth…After talking vigorously to my daughter-in-law and consulting a hepatologist, she came to realize that she had done her child serious harm. She changed the diet immediately and the boy is being trained. In addition, he is increasing his exercise. Hopefully, my grandson sees this and works on the therapy of his fatty liver and obesity himself.”
GLI Partner Highlight
American Society for Gastrointestinal Endoscopy
GLI is pleased to welcome the American Society for Gastrointestinal Endoscopy (ASGE) as one of the newest members of the GLI NASH Council. Founded in 1941, ASGE is dedicated to advancing patient care and digestive health and promotes excellence and innovation in gastrointestinal endoscopy. ASGE has more than 15,000 members worldwide. Read more on the ASGE website.
AMA Issues Two New CPT Codes for LiverMultiScan
The American Medical Association (AMA) has issued two new Current Procedural Terminology (CPT®) codes for Quantitative Multiparametric MR to report LiverMultiScan® produced by Perspectum. This new technology can help clinicians diagnose and treat patients with liver disease such as NASH and the new codes, effective July 1, 2021, will potentially provide millions of patients with access to this diagnostic tool. GLI played an integral role as the voice of patients in the October 2020 AMA CPT Editorial Panel meeting and advocated for these reimbursement codes, which were submitted collectively by the American College of Radiology, Radiological Society of North America, American Roentgen Ray Society, and Association of University Radiologists. Read more from Perspectum.
Research & Development
AASLD: Study Suggests Role for Semaglutide in NASH
Treatment with semaglutide — a glucagon-like peptide-1 (GLP-1) receptor agonist — may be an effective treatment for NASH, according to findings from a phase II study. However, although semaglutide achieved better resolution of NASH symptoms, it did not reduce fibrosis, said Philip N. Newsome, MB, ChB, PhD, of the National Institute for Health Research Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, England, and colleagues. Read more about the study in Physician’s Weekly.
Current NAFLD Guidelines for Risk Stratification in Diabetic Patients Have Poor Diagnostic Discrimination
In a study published October 27, the authors evaluate the current screening recommendations in the EASL-EASD-EASO and German guidelines (DGVS) for identifying patients at risk for NAFLD, especially regarding referral rates. The authors further identified factors that could facilitate referral decisions in primary care including a novel NASH surrogate score. The study (a) underlines the high prevalence of fibrosis risk in T2D, (b) demonstrates very high referral rates for in-depth hepatological work-up, and (c) indicates that simpler referral algorithms may produce comparably good results and could facilitate NAFLD screening. Read the study in the journal, Scientific Reports.
Review: Relationship Between Nonalcoholic Fatty Liver Disease and Coronary Heart Disease
Many pathophysiological changes and molecular mechanisms play an important role in NAFLD for cardiovascular disease formation. In a review from this past fall, Dr. Ugur Arslan and Dr. Mustafa Yenerçağ from Samsun Training and Research Hospital in Turkey aim to evaluate the relationship between NAFLD and coronary heart disease in detail and go over the pathophysiological mechanisms underlying this relationship. Read the review published October 26, 2020.
Women and Liver Cirrhosis: NAFLD Far Outpaces Booze
Women are suffering growing rates of liver cirrhosis, researchers in Canada's largest province found, although causes and future burdens vary considerably among age groups. The most important factors from a population standpoint are alcoholic liver disease and NAFLD, said Jennifer Flemming, MD, of Queen's University in Kingston, Ontario, in a presentation at The Liver Meeting. Read more on MedPage Today.
Clinical Care
GENFIT and LabCorp to Develop and Commercialize Blood-Based Molecular Diagnostic Test
As we continue to look Beyond the Biopsy and encourage the adoption of non-invasive diagnostics, GLI is pleased to see a new partnership that will bring an innovative test to patients and providers. LabCorp will be developing and commercializing a blood-based molecular diagnostic test, powered by GENFIT’s NIS4™ technology, that is specifically designed to identify patients with at-risk NASH. The test is expected to be available from LabCorp by early 2021 throughout the U.S. and Canada.
We look forward to seeing this and additional diagnostic tests for NASH become available for patients around the globe. Non-invasive screening and diagnostic tools can offer a safer and potentially more thorough examination of the liver than biopsies. Read the announcement from GENFIT and LabCorp.
EASL Policy Statement on the Coexistence of Alcohol-Related Liver Disease and Nonalcoholic Fatty Liver Disease
With this policy statement, EASL aims to inform politicians, policymakers, and the general population about the two leading causes of liver disease in Europe. The statement aims to educate readers on how behavioral risk factors may interact and lead to severe liver disease. Read the full statement and see additional policy statements from EASL.
Current Clinical Trials
Fatty liver disease (FLD) and non-alcoholic steatohepatitis (NASH) are increasing in prevalence worldwide, creating a major global public health crisis. To adequately educate patients, practitioners and policy makers, there is a need to collect, curate and share relevant information. NASH News, published on behalf of the Global Liver Institute’s NASH Council, intends to meet that need and to facilitate collaboration across the emerging NASH community on a monthly basis.
We would appreciate your feedback and content contributions. Please contact nash@globalliver.org