International NASH Day on June 12, 2019
Non-alcoholic steatohepatitis (NASH) has been called an epidemic, a ticking time bomb, and a silent tsunami. It is the progressive form of non-alcoholic fatty liver disease (NAFLD), and affects more than 115 million people worldwide. An estimated 357 million people will be affected by 2030.
Because NASH symptoms are not overt, NASH is often underdiagnosed and underreported. NAFLD and NASH are major risk factors for concurrent conditions: more than 70% are obese, up to 75% have type 2 diabetes, and anywhere from 20-80% have hyperlipidemia. Unchecked, NASH may lead to cirrhosis, liver cancer, and liver transplant.
Against this backdrop, the first International NASH Day (IND) was launched on June 12, 2018, with the goal of raising awareness about NASH and the actions people can take to prevent the disease. The program successfully launched events, briefings, media outreach, and social media interactions globally. Now under the Global Liver Institute’s leadership, International NASH Day is set to build on last year’s successes.
International NASH Day will be held June 12, 2019 and will kick off a year-long campaign to raise awareness of NASH with numerous events and awareness activities worldwide.
For those in Washington, I would like to highlight a local IND launch event, a Capitol Hill Briefing titled, The Rising Risks of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH). This educational briefing will be held from 12:00-1:00PM in Senate Russell 188. Other events in New York City, Brussels, Mexico City and elsewhere globally will soon be listed on our website. And more details will follow in the near future.
For more information and to get involved in IND please contact firstname.lastname@example.org or visit www.international-nash-day.com
Donna R. Cryer, JD
President & CEO
Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
AASLD/FDA DILI Conference (May 7-8, 2019)
Registration is open for the AASLD and FDA sponsored drug-induced liver injury (DILI) conference in Hyattsville, MD. All new drugs are evaluated for their effects on the liver.
This event will investigate current methods to assess and evaluate DILI risk in evolving therapies.
Register - early registration discounts end April 10.
“Request to Connect” - A New Way for Patients to Connect with FDA
The FDA Patient Affairs Staff has announced the FDA “Request to Connect” portal is now live
This new patient portal gives patients and caregivers a single entry point to the agency for questions and meeting requests.
Co-developed by the Patient Affairs staff and the medical product centers, the portal routes inquiries to the appropriate medical product center or office to ensure that they are received and answered in an effective and efficient manner. As patient populations and their needs evolve and become increasingly complex, Patient Affairs wants patients and those who advocate on their behalf to have an open door at the agency.
The National Cancer Institute Center for Cancer Research Liver Cancer Program: Special Conference on Tumor Metabolism
Registration is Open and Call for Abstracts!
Dates: Monday, October 28 2019, 8:00 am - 5:30 pm and Tuesday, October, 29 2019, 8:30 am - 12:00 pm
Location: NIH (Building 10, Masur Auditorium), Bethesda, MD
From National Cancer Institute (NCI):
This meeting will bring together experts in the multidisciplinary field of liver cancer to update research progress and future directions, with a focus on tumor metabolism. The meeting will also foster collaboration and team science among various disciplines of liver cancer research including epidemiology and translational science.
This meeting includes outstanding speakers in the fields of liver cancer and metabolism including keynote speaker Dr. Craig Thompson, a pioneer in studies of cancer cell metabolism.
Note: Registration is FREE! Abstract submission is now open and will close on June 25, 2019. Judging will be complete by July 31, 2019. Abstracts will be considered for poster presentations and the best judged abstracts will be selected for oral presentations and travel awards.
Attend first jointly hosted event by the Partnership to Improve Patient Care (PIPC) and the Coelho Center on Disability Law, Policy, and Innovation in Los Angeles
They welcome people with disabilities, patients, seniors, families, individuals experiencing disparities in care, providers and advocates to join an esteemed panel to learn about value assessments, their potential for discrimination, and related public policy threats at both the federal and state level.
Metrics for measuring “cost effectiveness” or value of treatments often relies on discriminatory methods, like the quality-adjusted-life-year (QALY), which values the lives of people with disabilities and serious chronic conditions as worth less than those of non-disabled people. QALYs are increasingly at the center of state and federal discussions about drug pricing, and advocates may be unfamiliar with how to engage with this complicated but important issue.
Disability rights advocates have long fought against QALY, achieving a prohibition against its use in Medicare within the Affordable Care Act. Previous administrations have ruled that using QALYs to allocate healthcare resources may constitute a violation of the Americans with Disabilities Act. But over the last few years, QALY-based proposals have become increasingly common, threatening access to lifesaving medications for people with disabilities and those with chronic illness.
This event will arm advocates with the information they need to oppose discriminatory measures in public programs, like Medicaid, and defend access to care for all.
Click here to RSVP.
POLICY DEVELOPMENTS AT GLI
GLI hosts first NASH Council Meeting of 2019 on May 16
On May 16th GLI will be hosting the first full NASH Council Meeting of 2019.
The NASH Council represents over 50 stakeholders including patient advocacy organizations, industry, and medical societies.
The purpose of the council is to underscore the urgency of developing mechanisms for quantifying and addressing the silent epidemic of fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) in the U.S. and abroad.
This year GLI is launching Beyond the Biopsy™, an initiative to raise awareness and to advocate for non-invasive technologies (NITs) to diagnose NASH. NITs are the theme of this month's NASH Council meeting.
Want to be a NASH Council member? Click Membership Application Form
Apply for GLI’s Advanced Advocacy Academy (A3) Class of 2019
Applications for GLI’s Advanced Advocacy Academy (A3) Class of 2019 are now open! A3 2019 will offer liver patients, caregivers, and professionals the opportunity to learn from experts in the fields of drug development, state and federal legislation, media and communications, and liver health and disease. If you or someone you know is interested in attending, visit the A3 website to learn more and to apply.
Opportunity still open to comment on GLI’s ICD-10-CM Hepatic Fibrosis Coding Proposal Committee Meeting
In March, GLI’s proposed ICD-10-CM coding change was presented at Center for Medicare and Medicaid Services (CMS). As a reminder, GLI and the NASH Council submitted a letter to the Centers for Disease Control and Prevention. Within the letter GLI expressed concern with the current ICD-10-CM coding, specifically, that it solely addresses hepatic fibrosis and cirrhosis, but does not distinguish patients with different stages of fibrosis.
GLI’s presentation stressed that revisions to the coding are necessary to enable liver fibrosis to be classified more accurately and more consistently with current clinical perspectives and documentation, particularly in the context of nonalcoholic steatohepatitis (NASH).
May 10, 2019 is the deadline for receipt of public comments on proposed new diagnostic codes and revisions discussed at the March 5-6, 2019 ICD-10 Coordination and Maintenance Committee meetings for implementation on October 1, 2020. If you are interested in submitting comments please submit directly to Donna Pickett, Co-Chair, ICD-10-CM Coordination and Maintenance Committee, at nchsicd10CM@cdc.gov.
The linked talking points provide more background that could assist in the creation of your own comments of support.
Inaugural Meeting of GLI Liver Cancers Council Is May 10
GLI has organized a meeting of liver cancer stakeholders to develop strategies and plans to raise awareness about the growing global prevalence of liver cancer and its high rate of mortality. Stakeholders have been invited from across sectors including patients, government agencies, professional societies, researchers, clinicians, providers, industry and others. A key topic at the first meeting on May 10, 2019 at GLI’s headquarters will be developing policies and practices to screen at risk patients so that liver cancers can be diagnosed at an early stage when treatments are known to be most effective. GLI plans that the Council will address a variety of important issues including disparities, obesigenic liver cancer, clinical trials, treatment access, prioritizing liver cancer in public health policies, and other critical topics. To learn about the GLI Liver Cancers Council or to attend the May 10 meeting, contact email@example.com.
GLI Signs onto Letter on Hepatitis Elimination Plan
GLI joined patient advocacy organizations in sending a letter to the current U.S. administration with the goal of ending viral hepatitis in the context of the Ending the Epidemic plan for HIV.
This past month the Administration released its budget proposal that focused funding on a few public health initiatives, specifically centered around ending HIV transmission in the United States over the next decade.
This letter asks the Administration to give the same priority to Hepatitis.
GLI Signs onto Letter on National Adult Hepatitis B Vaccination Awareness Day
GLI joined patient advocacy organizations in vocally showing support and submitting a letter to Congressman Hank Johnson (GA) and Congresswoman Grace Meng (NY), co-chairs of the Congressional Hepatitis Caucus.
They introduced a resolution on Tuesday, April 30, 2019 to designate April 30 as National Adult Hepatitis B Vaccination Awareness Day.
FOR YOUR CALENDAR
May 10: Global Liver Institute Liver Cancers Council inaugural meeting (see above)
May 16: Global Liver Institute NASH Council meeting (see above)
May 18-21: Digestive Disease Week (DDW)
May 16-19: National Lipid Association Annual Meeting
June 12: International NASH Day
September 20-22: International Liver Cancer Association Annual Meeting, Chicago
October 28-29: NCI Liver Cancer Program: Special Conference on Tumor Metabolism
November 8-12: AASLD, The Liver Meeting (Boston)
EASL Hosts International Liver Congress event:
Every year in April, scientific and medical experts from a broad range of fields including hepatology, gastroenterology, internal medicine, cell biology, transplant surgery, infectious diseases, microbiology and virology, pharmacology, pathology and radiology and imaging come together from around the world to learn about the latest in liver research.
Specialists share recent data, present studies and findings, and discuss the hottest topics on liver disease.
Obesity in NAFLD
To inform politicians, policy-makers and the general population across Europe about NAFLD and the measures required to prevent and treat this common progressive condition.
Liver Disease in Migrant Populations
To address the importance of liver disease, infection with hepatitis viruses and alcohol abuse in migrant, asylum seeker and refugee communities and to identify effective policies that prevent liver disease from occurring or that help to screen, treat and follow- up migrants who have or who go on to develop liver disease after migration.
The screening of blood donations for hepatitis E virus
As HEV infection can cause severe acute and chronic liver disease as well as a variety of non-liver disease manifestations, this policy aims to prevent transfusion-transmitted HEV infection by screening blood donations for HEV RNA.
Elimination of hepatitis C
To inform policy-makers, health care professionals, affected communities and patients that hepatitis C can- and should- be eliminated as a public health threat by 2030, or even earlier as could be the case in many central and western European countries
Reducing the burden of alcohol related liver disease
To address the health and economic burden that alcohol-related liver disease (ARLD) morbidity and mortality impose on society, and to define effective policies to reduce harmful alcohol consumption and related disease burden.
GLI attended this conference and met with EASL-ILF, WHO Europe, ECPC, ELPA, BLT, PBC Foundation, and German, Austrian, UK and Greek Patients Associations, AASLD and others including researchers, clinicians and providers.
The focus of these meetings was to discuss synergies between organizations, and collaboration on liver advocacy opportunities.
European Parliament's Vote on Horizon Europe
This past month the European Parliament endorsed the provisional agreement reached on Horizon Europe, a step demonstrating the EU goal of prioritizing research and innovation, including biomedical research
Horizon Europe is the EU research and innovation program. For the next budget period from 2021 to 2027, the European Commission proposed a budget of €100 billion.
GLI Highlight: Similar to GLI’s emphasis on the protection of funding for federal agencies within the U.S., GLI is also supportive of global or European programs that could lead to positive research and innovation that develop vital new therapies for patients.
First Drug Pricing Bill This Congress Signed Into Law:
This past month President Donald Trump signed a bill into law that allows the government to stop drug companies from avoiding paying higher Medicaid rebates by misclassifying brand drugs as generics.
The bipartisan Right Rebate Act was included in a larger Medicaid package and spurred by Mylan’s misclassification of EpiPen.
Senate Finance Chair Chuck Grassley (R-IA) and ranking Democrat Ron Wyden (OR) introduced the legislation to stop abuses uncovered by Grassley’s investigation of EpiPen and the Medicaid Drug Rebate Program.
Also this past month the U.S. House Energy and Commerce Lawmakers passed by voice vote with none opposing the CREATES Act, which would penalize brand-name drug manufacturers that withhold sample products from generic makers by citing safety concerns, and another bill, which bans brand manufacturers from striking deals with generic rivals to keep their products off the market, after several amendments that limit the scope of both bills.
United States House of Representatives Hold Insulin Drug Pricing Hearing:
House lawmakers questioned drugmakers for high insulin prices during a hearing last month.
Lawmakers from both parties pressed pharmaceutical executives on why manufacturers have not lowered insulin list prices — which have climbed roughly 700 percent over 20 years — during an oversight subcommittee meeting that also featured witnesses from the pharmacy benefit management companies -- CVS, Express Scripts and OptumRx.
After the hearing, Rep. Michael Burgess said Medicare and Medicaid should consider covering insulin without cost-sharing because the cost to the health care system of diabetics rationing the drug is likely greater than the additional cost of covering it outright. Fellow Republican Rep. Morgan Griffith (VA) seconded the idea, as did Democrat Rep. Jan Schakowsky (IL).
GLI attended this hearing, and actively monitors drug pricing legislative changes that impact patient access.
GLI”s position focuses on access and affordability of medications for patients while recognizing that a sustainable solution (not just a slogan) also ensures that innovation in drug development is incentivized.
U.S. Federal Budget
U.S. Senate Appropriations Labor-HHS Subcommittee Hearing with HHS Secretary Alex Azar:
This past month, HHS secretary, Secretary Alex Azar defended his agency’s FY 2020 budget request before the Senate Appropriations Labor-HHS subcommittee.
Democrats focused their attention on why HHS cut funding for Affordable Care Act (ACA) outreach, why the Justice Department is calling for the courts to overturn the ACA and how Azar's agency has handled migrant children separated at the border.
Senator Patty Murray (D-WA) also probed Azar's plan to reorganize the offices that oversee the Title X family planning and teen pregnancy prevention programs.
Republicans similarly expressed displeasure over proposed HHS cuts to agencies like NIH.
GLI attended this hearing. As an organization we are against cuts to NIH, CDC, or HHS at large.
GLI will continue to push to protect the funding of federal agencies that protect patient lives, and promote the development of valuable new therapies for all Americans, especially those impacted by liver health complications.
U.S. Senate Appropriators Question Liver Allocation Policy:
The Subcommittee’s hearing on the Administration’s budget switched focus to an important liver health issue.
Senator Roy Blunt (R-MI) focused a majority of his questions on the recently released Liver Allocation Policy.
He asked if Sec. Azar would request the Organ Procurement and Transplantation Network (OPTN) to delay the policy.
Sen. Blunt made it clear that this proposed policy would lead to 32% fewer liver transplants in Missouri, and have horrible unintended consequences.
In January Sen. Blunt led 20 Senate colleagues in submitting a bipartisan letter to Sec. Azar demanding answers from OPTN.
Sec. Azar explained that his hands are tied because OPTN is not under his control. However, from GLI’s perspective, It was important to have such an important liver health policy issue addressed.
Senator Moran (R-KS) followed Sen. Blunt stressing that not enough is being done to protect people who currently are on the transplant wait list and that OPTN did not listen to constituent comments when the new allocation policy was released.
Sec. Azar conceded that the most important thing is to increase the supply of livers. Sen. Moran then made the point that there needs to be a full re-evaluation of the organ donation and recovery process.
GLI was present for this section of the appropriations hearing as well.
It was great to see such an important liver issue centerstage. As an organization,GLI has major concerns with the proposed liver allocation policy. GLI’s position is that the proposed policy will undermine the community benefit of community organ donation, reward underperforming organ procurement organizations, and ignore the science of negative impact of longer ischemic time on organ viability and patient outcomes.
Senate Members Send Letter to Appropriators Requesting a Strong Commitment to the NIH in FY 2020
Senate appropriators said they will reject President Trump's proposal to cut NIH's budget 13 percent and instead hope to increase funding for the research agency.
NIH Director Testifies Before House Appropriations Subcommittee
The National Institutes of Health (NIH) Director Francis Collins, MD, PhD, and directors of specific Institutes (NIAID, NCI, NIGMS, NIDDK, NIA, and NIDA) testified April 11th on the fiscal year (FY) 2020 budget proposal before the Senate Appropriations Labor-HHS Subcommittee.
Both sides of the aisle agree that cutting NIH is not desirable.
GLI attended this hearing. As an organization, GLI supports increased funding for NIH, CDC, and HHS at large.
GLI will continue to push to protect NIH funding and for other federal agencies that protect patient lives and promote the development of valuable new therapies for all Americans, especially those impacted by liver health complications.
U.S. House of Representatives Appropriators Propose Their Own Federal Budget Bill
House appropriators are proposing an $8.5 billion increase to HHS' budget as part of their fiscal 2020 spending bill.
The draft plan would boost the HHS budget to $99 billion and target new spending for a series of major public health priorities, including research on gun violence.
The bill provides a total of $41.1 billion for NIH, an increase of $2 billion above the 2019 enacted level and $6.9 billion above the President’s budget request.
In his budget request earlier this year, President Trump sought a 12 percent reduction of HHS' budget that included cuts to NIH and CDC, as well as the planned repeal and replacement of Obamacare.
Appropriations' Labor-HHS-Education Subcommittee plans to mark up the spending draft on April 30th.
This is positive news and shows clear support from the House of Representatives to preserve valuable programs within HHS agencies that protect patient lives.
At this time, however, there remains minimal emphasis on funding of liver health research within NIDDK, an issue GLI is addressing..
However, there is positive support and funding for valuable cancer related programs within NCI.
Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility. Funding available from NIH Application Deadlines: May 7th, 2021.
NAMES TO KNOW
Senator Jerry Moran (R-KS) - Kansans elected Jerry Moran to the U. S. Senate in 2010. Since joining the Senate, Senator Moran has been a leading advocate for protecting liver transplant patients.
TERMS TO KNOW
The Organ Procurement and Transplantation Network (OPTN) - OPTN is a unique public-private partnership that links all professionals involved in the U.S. donation and transplantation system.
The National Organ Transplant Act (NOTA) established OPTN in 1984.