Forging a Global NASH Policy Framework

POLICY PERSPECTIVE

Forging a Global NASH Policy Framework

The Global Liver Institute has seized the opportunity to lead in the forging and articulation of the policy framework that will support the emerging movement to recognize and address the public health epidemic in fatty liver disease and nonalcoholic steatohepatitis (NASH), facilitating discussions in GLI’s NASH Council policy workgroup, and consulting with groups from AASLD to ELPA. First at a June 11th briefing to staff at the U.S. Congress as part of the inaugural International NASH Day activities and subsequently as part of the closing panel of international thought leaders at the July 6th Paris NASH Summit, GLI CEO Donna Cryer identified how policymakers can make a meaningful impact on the NASH public health crisis:

Include NAFLD/NASH as part of  WHO Noncommunicable Disease Prevention and Control efforts

Currently cardiovascular diseases, cancer, chronic obstructive lung disease, diabetes, and mental health are recognized for the challenge they place on achieving sustainable development.  

Allocate funding for National Academies of Sciences, Engineering, and Medicine study

The National Academies have already published robust consensus study reports in liver health, including Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C (2010) and A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report (2017). These reports can lay the foundation for a national approach to addressing NAFLD/NASH.

Support funding for research in NASH and obesity-driven cancers within and across Institutes of the National Institutes of Health

Research on NASH and other liver diseases do not match their incidence, prevalence, and growth trends. There are opportunities to strengthen existing programs such as the NASH-CRN and NIMBLE, to consider NAFLD/NASH as part of programs such as those on gestational diabetes, as well as to launch new efforts that harness the collective expertise of the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), National Heart, Lung and Blood Institute (NHLBI), National Cancer Institute (NCI), and National Institute for Allergy and Infectious Diseases (NIAID).

Create a coordinated Division for Liver Health within Centers for Disease Control and Prevention (CDC)

With efforts spread across Divisions of viral hepatitis, obesity/nutrition, and cancer, the full scope and impact of liver diseases including NAFLD/NASH, are underrecognized and cohesive, comprehensive public health solution generation is hampered.

Establish Congressional Liver Health Caucus

Policymakers should create a Liver Health Caucus using the support of existing caucuses with interests related to liver health such as the Hispanic Caucus, the Public Health Caucus, the Diabetic Caucus, and the Cancer Caucus.

Preserve pre-existing conditions in health insurance coverage

To ensure that NAFLD/NASH patients are able to receive appropriate care now and after the development of specifically indicated therapies, it is necessary for policymakers to protect the pre-existing conditions provisions of the Affordable Care Act.

To learn more about or participate in the formulation of NASH policy in the U.S. or globally join the GLI NASH Council.

OPEN ADVOCACY OPPORTUNITIES

In part of the FDA’s ongoing commitment to gathering patient experience data, the FDA will hold a Public Meeting on Patient-Focused Drug Development for Chronic Pain. The public meeting (in person or webcast), to be held on July 9, 2018, will be a great opportunity for liver patients to voice their opinions and share their experiences with drug management of chronic pain within their unique  diseases. Sign up now.

July 17th&18th: National Committee on Vital and Health Statistics

Liver Health Advocates

GLI recently created a new Facebook group called Liver Health Advocates- Please join our space to discuss your advocacy needs, share your experiences, and connect with fellow liver advocates! Invite your fellow liver patients, support networks, and others who can help advocate for liver health.

POLICY DEVELOPMENTS AT GLI

NCCN Hepatobiliary Cancers Patient Guidelines

The National Comprehensive Cancer Network (NCCN) has released its first ever NCCN Guidelines for Patients on Hepatobiliary Cancers along with the accompanying NCCN Hepatobiliary Quick Guide™. The Guidelines are sponsored by GLI and its content is endorsed by the Cholangiocarcinoma Foundation. The guidelines contain evidence-based and expert-consensus treatment recommendations to help patients and caregivers understand treatment decisions and navigate care.

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STATE ACTION

Virginia became the 33rd state to expand Medicaid. The expansion, included in their budget, came after years of effort and is expected to expand coverage to an additional 400,000 individuals. Although Maine was the first state to expand Medicaid, Governor Paul LePage is refusing to implement the expansion.

Following the repeal of the Affordable Care Act’s individual mandate provision at the beginning of this year, some states are now choosing to pass their own mandate requirements. New Jersey passed the “New Jersey Health Insurance Market Preservation Act” (S.1877) and Vermont passed H.696, both of which place mandate requirements in their respective states for individuals to purchase health insurance.

Texas has the highest uninsured rate of healthcare in America. The Kaiser Family Foundation conducted a survey on Texans’ attitudes towards their state policies, finding that a majority (55%) want to increase access to health insurance and many (46%) want to expand Medicaid to cover more low-income populations.

Connecticut Governor signed bill HB.5384, “An Act Concerning Prescription Drug Costs” which will place more cost disclosure requirements on Pharmacy Benefit Managers (PBMs), health carriers, and drug makers.  This is a step forward for increasing cost transparency between PBMs and the general public.

Kentucky was the first of five states to receive approval from the Department of Health and Human Services (HHS) to place work requirements and higher premiums on Medicaid. The waiver would have cut an estimated 95,000 people from Medicaid, including current low-income workers. The National Health Law Program, the Kentucky Equal Justice Center, and the Southern Poverty Law Center sued HHS for approving Kentucky’s waiver, hoping to invalidate it and prevent other states from instituting prerequisites to obtain Medicaid. In reaction to the suit, Kentucky Governor Matt Bevin issued an executive order claiming that if U.S. District Judge James Boasberg rules against the waiver, Kentucky will end its Medicaid expansion that provided coverage to an additional 400,000 people. Two days before the waiver would be put into effect, Judge Boasberg overturned it.

Michigan Governor Rick Snyder signed a bill (S.897) on June 22nd, becoming the fifth state to place work requirements on Medicaid. The bill will be implemented in 2020, and it is estimated to affect 670,000 current Medicaid recipients by requiring adults with adequate health to participate in at least 80 hours of work per month. Under this law, it will become more difficult for low-income people to be eligible for Medicaid and many people speculate that the state will be sued following the current lawsuit in Kentucky.

California has passed a budget that sets aside $70 million to provide drug treatment for hepatitis C patients covered by Medi-Cal, the Medicaid in California. For the past four years, Medi-Cal severely restricted coverage of hepatitis C medications. The budget, effective on July 1st, will increase eligibility to almost all Medi-Cal recipients with hepatitis C as long as they are at least 13 years old and have a life expectancy of one year or more.

California Court of Appeal has issued an immediate stay on an aid-in-dying law, the End of Life Option Act. The law, once temporary, would permit physicians to help terminally ill patients who request medication to end their lives.

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GLOBAL

World Health Organization (WHO)

The WHO’s Independent High-level Commission on Noncommunicable Diseases (NCDs) released a report with six new recommendations for combating the rise of noncommunicable diseases like cancer, diabetes, obesity, and mental health disorders. The commission urged leaders to remain focused on the NCDs Sustainable Development Goal which is expected to be met by 2030, and commission Co-chair Dr Sania Nishtar pressed that “We know the problem and we have the solutions, but unless we increase financing for NCDs, and demand all stakeholders be held responsible for delivering on their promises, we won’t be able to accelerate progress.”

British Liver Trust

The British government under Prime Minister Teresa May will be releasing a 10-year plan to increase funding for the National Health Service (NHS) before its 70th anniversary on July 5th.  Prior to its release, the British Liver Trust has been working with cancer charities to urge the new NHS plan to have a bigger focus on liver cancer and other serious types of cancer.

.GOV NEWS

Food and Drug Administration (FDA)

The FDA has placed a lot of importance on the patient voice in the drug development process. In FDA Commissioner Scott Gottlieb’s statement on new agency efforts to advance medical product communications, he stressed that scientific advancement works best when it is coupled with patient feedback. On June 12th, the FDA released their newly organized plan for collecting patient insights called Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.

The FDA’s Center for Drug Evaluation and Research (CDER) proposed new procedures to review new drugs. FDA proposed to recruit individuals from different fields and form multidisciplinary teams to provide a comprehensive approach to the review process. Additionally, FDA proposes to make the process more efficient by making the Office of New Drugs (OND) the main contact for managing each application, a reduction from the 19 offices that are currently involved. FDA is committed to maintaining high safety standards while also improving the speed and efficiency of the drug approval process.

Department of Health and Human Services (HHS)

On June 19th, a rule to advance new health plans was finalized. This rule will increase the number of association health plans (AHPs) by making it easier for small businesses and individuals to group together and receive lower health insurance costs. “Many of our laws, particularly Obamacare, make healthcare coverage more expensive for small businesses than large companies. AHPs are about more choice, more access, and more coverage,” said Labor Secretary Alexander Acosta. However, it is expected that such health insurance will provide fewer benefits and are will make coverage more expensive for Obamacare recipients, older workers, and women by basing insurance rates on the gender, age, and industry of its recipients. New York and Massachusetts Attorney Generals plan to sue the administration, citing that association health plans do not follow Affordable Care Act’s requirements and will “invite fraud, mismanagement and deception.”

National Cancer Institute (NCI)

The National Cancer Institute recently found that there is a connection between the composition of gut microbiome bacteria and antitumor growth in the liver. In a research study, mice were treated with antibiotics that altered the bacterial makeup of the immune cells in their liver, ultimately protecting them from tumor growth. This finding could lead to new treatments for liver cancer and tumor growth.

NCI awarded a $2.3M grant to the University of Hawaii Cancer Center and The Queen’s Medical Center for the research of new methods to detect liver cancer. The award follows research reporting that Hawaii has the highest liver cancer rates nationally.

National Institutes of Health (NIH)

President Trump signed the STAR Act (S.B. 292) into law on June 5th, which authorizes NIH to collect biomedical samples and information from children with cancers that have the least effective treatments. The act, advocated by Sadie Keller, an 11-year old cancer survivor, and Representative Michael McCaul, will earmark $30 million annually from 2019 to 2023 for NIH, encouraging further research and better understanding of pediatric cancers, such as liver cancer, and treatment alternatives. The National Coalition for Cancer Survivorship (NCCS) has voiced its strong support of the STAT Act as a "significant achievement in the effort to expand cancer research and treatments for children with cancer.”

Centers for Disease Control and Prevention (CDC)

The CDC published a report on obesity prevalence using data from the 2016 Behavioral Risk Factor Surveillance Survey.  Consistent with past findings, obesity rates are higher in rural areas (34.2 percent) compared to metropolitan/urban areas (28.7 percent).  Obesity is not only a risk factor for diabetes, heart disease, cancers, arthritis, but it is also a major contributing factor to the development of fatty liver disease and NASH.

On June 12th 2018, the U.S House of Representatives passed the “Eliminating Opioid Related Infectious Diseases Act of 2018” (H.R. 5353), amending the Public Health Service Act of 1944. Specifically, the act authorizes $40million a year over 5 years to the CDC to aid in mobilization of resources to combat the rise of HIV and viral hepatitis C cases accelerated from the opioid epidemic.The goal is to “reauthorize and expand” community based programs for surveillance, education, testing and prevention of infections associated with injection drug use.

GRANT OPPORTUNITIES

Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility (R01 - Clinical Trial Not Allowed). Funds available from NIH: Application budgets are not limited. Application deadlines: July 5, 2018 or November 5, 2018

Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (R21 Clinical Trial Optional). Funds Available from NIH: $200,000. Application deadlines: July 16, 2018, or November, 2018

Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (R01). Funds available from NIH vary with project scope. Application deadlines: July 12, 2018, November 12, 2018, and March 12, 2019.

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NAMES TO KNOW

Dr. Stephen Harrison, MD: Dr. Harrison currently serves as the Medical Director for Pinnacle Clinical Research and has contributed to 150 publications on hepatitis C and non-alcoholic fatty-liver disease. At a congressional briefing hosted by the NASH Education Program in early June, Dr. Harrison addressed the risks associated with the progression of fatty liver disease.

https://www.the-nash-education-program.com/news-medias/educational-videos/

TERMS TO KNOW

Survivorship is a term often used by to describe the period of time after cancer treatment until the end of life. Survivorship comes with physical, psychosocial, and economic hardships that may not only affect the cancer patient but also their family, friends and employers. GLI suggests that patients learn about options the organization offers to get involved -- a healthy way to enhance quality of life in survivorship..

Palliative Care: Contributed by a team of physicians, nurses, physiotherapists, occupational therapists among other health professionals to provide care for people with life-limiting illnesses. The goal of palliative care is to improve the quality of life for the patient and their family by relieving pain and physical and mental stress. Some studies found that palliative care is effective and significantly reduced health care costs, leading to many recently proposed legislation to research or support palliative care.

Policy UpdatesDonna Cryer