U.S. NASH 
  Action Plan
                Council
                Contents
                Executive Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1
                Background ..............................................................3
                      The Impact of NASH on Patients and Families ...............................3
                      The Impact of NASH on Public Health ......................................4
                      The Impact of NASH on the Economy ......................................5
                The Issues ...............................................................6
                      Lack of Awareness and Education   ........................................6
                      Lack of Agreement on How to Diagnose NASH ...............................6
                      Lack of Standardized Patient Management and Treatment for NASH ..............8
                      Lack of NASH Specific Policy Initiatives Leading to Poor Health System Preparedness 10
                The Recommendations .....................................................12
                      Patients and Caregivers .................................................13
                      Clinicians ............................................................14
                      Medical Societies ......................................................15
                      Patient Advocacy Organizations ...........................................17
                      Industry ..............................................................19
                      Health Systems .......................................................20
                      Payors ..............................................................21
                      Regulators ...........................................................22
                      Policymakers  .........................................................23
                Measuring Progress .......................................................26
                Conclusion ...............................................................26
                                                   Global Liver Institute                   NASH Action Plan
             Executive Summary
             By most recent estimates, up to 444 million people  health organizations from the start to identify 
             worldwide and 40 million in the United States1 are  a framework for high-functioning disease state 
             living with a progressive, chronic liver condition  advocacy. There are currently more than 70 
             referred to as nonalcoholic steatohepatitis (NASH),  members of the NASH Council including the 
             the advanced form of fatty liver disease (NAFLD).  American Association for the Study of Liver 
             On top of this is that an estimated 10% of children  Diseases (AASLD), the Endocrine Society, the 
             in the United States also currently have NASH.2 3 4  Obesity Action Center (OAC), the American Cancer 
             NASH is closely associated with obesity, diabetes,  Society, the American Heart Association, the 
             chronic kidney disease, and cardiovascular American Gastroenterological Association (AGA), 
             disease (CVD) and is projected to rise in parallel to  the American College of Physicians, the American 
             these diseases.5                                            Nursing Association, Duke University School of 
             As a patient-driven multi-stakeholder community  Medicine, University of California San Francisco 
             for whom addressing this disease is a life-and-             Medical Center, Massachusetts General Hospital/
             death issue, we strongly believe that 2021 is  Harvard Medical School: Fatty Liver Disease 
             a  crucial  time  to  frame  a  set  of  specific  action   Clinic, Fatty Liver Foundation, NASH kNOWledge, 
             steps for the nation to begin taking to ensure that  the Liver Forum, and more.
             no more lives are lost unnecessarily from this  In 2020, GLI and the NASH Council released the 
             disease. In 2015, it was estimated that there were  resource, The Language of NASH: A Narrative 
             370,000 deaths among the NASH population;  to Guide Communication on NASH. This core 
             however, more than 90% of the deaths were  NASH messaging framework was designed to 
             classified as due to general background or excess  establish consistent and meaningful terminology 
                              6
             cardiovascular.  Population-level NASH death rate  and messaging to be used as a foundation for 
             data remains a critical issue that leads to difficulty  communication in all areas around NASH. GLI 
             in grasping the scope of the NASH crisis.                   and the NASH Council now hope to build upon this 
             Global Liver Institute (GLI) created the NASH  messaging report by releasing a set of actionable 
             Council  in  2017,  defining  a  community  around  recommendations for the NASH community in the 
             creating solutions for a liver condition, more  form of this U.S. NASH Action Plan.
             broadly and inclusively than had ever been done  This U.S. NASH Action Plan is the logical next 
             previously. GLI and the NASH Council invited  step in the work of the GLI NASH Council, 
             cardiology, endocrinology, and minority serving  setting an agenda and detailed roadmap with 
             1  Spengler EK, Loomba R. Recommendations for diagnosis, referral for liver biopsy, and treatment of nonalcoholic fatty liver 
                 disease and nonalcoholic steatohepatitis. Mayo Clinic Proceedings. 2015;90(9):1233–1246.
             2  J Pediatr. 2013;162(3):496–500.e1 Welsh JA, Karpen S, Vos MB. Increasing prevalence of nonalcoholic fatty liver disease 
                 among United States adolescents, 1988-1994 to 2007-2010.
             3  Pediatrics. 2006;118(4): 1388–1393 Schwimmer JB, Deutsch R, Kahen T, Lavine JE, Stanley C, Behling C. Prevalence of 
                 fatty liver in children and Adolescents.
             4  J Pediatr. 2018;200:174–180 Fernandes DM, Pantangi V, Azam M, et al. Pediatric nonalcoholic fatty liver disease in New 
                 York City: an autopsy study.
             5  Younossi ZM, Koenig AB, Abdelatif D, et al. Global epidemiology of nonalcoholic fatty liver disease meta-analytic assessment 
                 of prevalence, incidence, and outcomes. Hepatology. 2016; 64:73–84.
             6  Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates 
                 an exponential increase in burden of disease. Hepatology. 2018;67(1):123-133. doi:10.1002/hep.29466
                                            Global Liver Institute              NASH Action Plan                                 1
              recommendation for meaningful activities for 
              each relevant stakeholder group — patients/
              carepartners, clinicians, medical societies, patient 
              advocacy organizations, industry, payors, health 
              systems, regulators, and policymakers.
              Our collaborative process has determined that four 
              critical overriding issues must be addressed to 
              save lives and stop the rise of this life-threatening 
              disease:
                   1.    Lack of awareness and education 
                   2.    Lack of agreement on how to diagnose
                   3.    Lack of standardized patient 
                         management and treatment for NASH
                   4.    Lack of NASH-specific policy initiatives 
                         leading to poor health system 
                         preparedness
         2                                     Global Liver Institute                NASH Action Plan