We Must Take Action And Include Liver Cancers In The National Cancer Conversation



Mortality rates for all cancers combined have steadily declined since 1990, yet liver cancer mortality rates continue to rapidly increase.

Last year this news was briefly brought into the national spotlight by a CDC report that highlighted the point that liver cancer has risen from 9th highest cancer mortality rate in 2000 to 6th highest in 2016. In this time, liver cancer mortality has increased 43%. In 2018 it was estimated that 42,220 adults (30,610 men and 11,610 women) in the United States will be diagnosed with primary liver cancer, with a 5-year survival rate of only 18%. Even more damning is that liver cancers exhibit health disparities across racial, ethnic, gender, and education groups. Yet, even with this harsh reality this deadly disease continues to receive minimal attention.

It is important to understand that liver cancers can have silent signs and symptoms in the early stages, but they are treatable by an increasing number of therapies. The success of these therapies can be based on whether the cancers are diagnosed early.

In response to this rising epidemic we must promote better communication of risk factors to specific patient groups. Unlike most other cancers for which the causes are unknown, the cause of liver cancers are well known, identifiable, and thus highly preventable with regular screenings. Early stage localized liver cancer has a 5 year survival rate of 31% but decreases to just 11% in later stages. Liver cancer screenings and improved physician-patient communication are essential to combat this disease.

Knowing this, why has the U. S. Preventive Services Task Force (USPSTF) not made any screening recommendations for liver cancers? If this epidemic impacts so many lives and has an available means to reduce its mortality rate, why is so little attention given to it in practice and policy?

The numbers speak for themselves! Implementing screening standards and raising awareness of the potential signs and symptoms of this disease are necessary initial steps. I am not alone in this belief; medical literature and others with expertise in this clinical topic echo my point. They have even gone on to make the specific recommendation that liver disease patients get screened for cancer every 6 months.

If we do not take action the liver cancer epidemic will continue to grow. Nationally we must consider the implications of liver cancers, and develop a response plan. Effective strategies must begin with preventative measures taken by individuals educated and aware of potential risk factors. The USPSTF must provide screening guidelines on liver cancers, which in turn will provide a starting point for catching this treatable disease. We must act now to save patients lives!


Donna R. Cryer, JD
President & CEO
Global Liver Institute


International NASH Day on June 12, 2019

International NASH Day (IND) will be held June 12, 2019 and will kick off a campaign to raise awareness of NASH with numerous events and awareness activities worldwide.

International NASH Day Goals

  • Increase awareness

  • Increase the number of patients diagnosed and linked to clinical trial opportunities

  • Create a call to action and mobilize the community to be active on policy

For those in Washington, we would like to highlight a local IND launch event, a Capitol Hill Briefing titled, The Rising Risks of Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH). This educational briefing will be held from 12:00-1:00PM in Senate Russell 188. Other events will occur in New York City, Brussels, Mexico City, Moscow, Brazil, India and elsewhere globally.

GLI invites all organizations that promote liver health and public health to join in raising awareness about NASH. On June 12, you can join our chorus of online #NASHday messages or announce a future event. Click here for our Social Media Guide and more event information. Questions? Contact us at nashday@globalliver.org.

“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.



GLI Hosted the First NASH Council Meeting of 2019 on May 16

On May 16th GLI hosted the first full NASH Council Meeting of 2019. The NASH Council represents over 50 stakeholders including patient advocacy organizations, government agencies, 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 nonalcoholic 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 were the theme of this past month's NASH Council meeting. To build on this theme, the NASH Council included presentations from Dr. Tania Kamphaus of FNIH and NIMBLE, and Professor Stefan Neaubaur MD of the University of Oxford.

Want to be a NASH Council member? Click Membership Application Form

Inaugural Meeting of GLI Liver Cancers Council Was Held on May 10

GLI 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 were 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 was 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, contact jdelgrande@globalliver.org.

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 take place on November 1-2, 2019 at GLI Headquarters in Washington, DC. This year’s program 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, or email a3@globalliver.org with any questions.

GLI Signs onto Patient-Centered Outcomes Research Institute (PCORI) Reauthorization Letter

GLI joined many patient advocacy organizations in vocally showing support and submitting two letters to Congress to protect funding for the Patient-Centered Outcomes Research Institute (PCORI).

PCORI is the only organization dedicated to funding comparative clinical effectiveness research (CER) comparing which treatment approaches work best, for which patients, given their needs and preferences. PCORI seeks to empower patients, and build evidence to drive innovation to improve health decisions.

GLI Signs onto Letter to FDA Regarding Naming of Biologic Medicines

GLI signed onto a letter regarding the naming of biologic medicines with 124 like minded individuals and 56 organizations. The letter was submitted through the comment portal on 5/7/19.

GLI supports distinguishable suffixes for all new biologics –originator, biosimilar and interchangeable products – and urges the FDA to continue to implement the policy as presented within their March 2019 update.

Patient safety must always be a top priority of the FDA. The naming policy designed by FDA effectively addresses the need to distinctly identify each biologic product. A unique suffix attached to the core nonproprietary name enables biologics to be prescribed, dispensed and tracked with specificity.

Final Comments Submitted on GLI’s ICD-10-CM Hepatic Fibrosis Coding Proposal

In March, GLI’s proposed ICD-10-CM coding change was presented at the 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 was 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. Comments of support were submitted by a wide range of stakeholders including physicians, patient advocacy organizations, industry, and individual patient advocates.

As of the writing of this update the following stakeholders had submitted comments of support:

  • American Association for the Study of Liver Disease

  • American Gastroenterological Association

  • Apollo Endosurgery, Inc.

  • Bristol-Myers Squibb

  • Fatty Liver Foundation

  • Gilead Sciences, Inc.

  • Intercept Pharmaceuticals

  • Multiple Individual Advanced Advocacy Academy (A3) Alumni (Patient Advocates)

  • NASH kNOWledge

  • Obesity Action Coalition


American Society of Clinical Oncology Annual Meeting May 31-June 4

American Diabetes Association (ADA) Annual Meeting June 7-11

American Academy of Sleep Medicine Annual Meeting June 8-12

International NASH Day June 12

European League Against Rheumatism (EULAR) Annual Meeting June 12-15

14th Euro-Global Gastroenterology Conference (Gastro Congress 2019) July 8-9

Paris NASH Meeting July 11-12

7th International Conference on Hepatology (Hepatology 2019) July 15-16

16th World Congress on Gastroenterology & Therapeutics (World Gastroenterology 2019) July 15-16

International Liver Cancer Association Annual Meeting September 20-22

NCI Liver Cancer Program: Special Conference on Tumor Metabolism October 28-29

American Public Health Association November 2-6

American Association for the Study of Liver Disease, The Liver Meeting November 8-12


New NASH Policy Report Incoming by The Health Policy Partnership

A new policy report on non-alcoholic steatohepatitis (NASH) is being developed by The Health Policy Partnership (HPP) in collaboration with a steering committee consisting of Professor Quentin M. Anstee, Dr. Farhana Bin Lootah, Ms. Donna R. Cryer, Dr. Hannes Hagström, Dr. JeffreyV. Lazarus, Professor Michael P. Manns, Professor Manuel Romero-Gómez, Professor Lawrence Serfaty and Dr. Zobair M. Younossi.

The report aims to prompt a measured policy response to the anticipated rise of NASH in years to come. Focused on Europe and the Middle East, it offers up-to-date estimates of the epidemiology and impact of NASH, and highlights key strategic issues to improve clinical management and health system preparedness from a policy perspective. The report proposes five key recommendations for action for policymakers. It will be launched on International NASH Day and hosted on the HPP and the International NASH Day websites. The report has been initiated and funded by Gilead Sciences Europe. Gilead has had no input into the report content. To find out more about the report, please contact Emmanuelle Plucker at HPP, Emmanuelle.plucker@hpolicy.com.

EASL releases policy statement about NASH NAFLD

Nonalcoholic fatty liver disease (NAFLD) affects approximately 1 in 4 members of the general population across Europe and so is a major health problem due to its high prevalence, capacity to progress to liver cirrhosis and liver cancer, and also because it is associated with a greater risk of cardiovascular disease & other malignancies. EASL suggests that policy interventions at population and individual levels are necessary in order to reduce the growing burden of liver disease arising due to NAFLD.

EASL’s full policy statement is included here.

72nd World Health Assembly highlights WHO’s strategic priorities

The Seventy-second World Health Assembly ran from May 20th to May 28th 2019 in Geneva, Switzerland.

Over the course of the Assembly, delegates focused on a specific health agenda prepared by WHO’s Executive Board. Their discussions and decisions will help to determine the policies and budget of WHO, and will serve as important guidance for taking collective action on health priorities in the coming years.

The 2019 agenda covers a number of key strategic priorities for WHO that follow up on the Organization’s 13th General Programme of Work. These include implementing the 2030 Agenda for Sustainable Development, and specifically moving towards universal health coverage (UHC) and strengthening primary health care. These sessions will contribute to preparations for the high-level meeting of the United Nations General Assembly on UHC this autumn.

Please click here to read more about the outcome of the World Health Assembly.


Centers for Medicaid and Medicare Services (CMS) Abandons Plan to Weaken Patient Access

Over the last few months GLI has joined many patient advocacy organizations in actively voicing their concerns to CMS about their proposed plan that would weaken the six protected drug classes within Medicare Part D.

As a reminder, CMS identified six “categories and classes of clinical concern,” commonly known as the “six protected classes,” and required Part D plans to cover “all or substantially all drugs” within each of the classes. These six protected classes include: anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants. The antineoplastics category includes many oral chemotherapy drugs.

By removing coverage this rule change would of had a clear negative impact on liver patients and could promote step therapy within Medicare Part D.

This past month the Department of Health and Human Services (HHS) issued its final rule for Medicare Part D which does not include the full range of proposed changes to drugs in the ‘six protected classes.’

HHS had proposed allowing plans to use additional utilization management, like prior authorization and step therapy, for all drugs in these classes, however the final rule would not interfere with already established medication regimens for patients.

This is a positive response from CMS. GLI is focused on ensuring that patients have access to the right medicines, at the right time, and at costs they can afford. There is still a lot of work to be done to protect patient access, but this is still a positive initial outcome.

 U.S. Federal Budget

The House of Representatives Labor-HHS-Education Appropriations Subcommittee advanced FY 2020 spending draft

This past month House appropriators approved a roughly $200 billion fiscal 2020 spending draft for the departments of Health and Human Services, Labor and Education.

The blueprint for Congress' largest domestic spending bill would earmark about $99 billion for HHS, an increase from the enacted fiscal 2019 level that represents a rebuke of President Donald Trump's bid to slash funding to the department.

The House Labor-HHS-Education Appropriations Subcommittee also released report language to accompany its draft FY 2020 spending bill.

For the first time the Committee recognized many key liver health issues.

They highlighted that the prevalence of nonalcoholic fatty liver (NAFLD) disease and nonalcoholic steatohepatitis (NASH) is growing dramatically in the U.S. The Committee encouraged the CDC to develop prevention, education, diagnosis, and treatment programs to combat existing incidence and provide appropriate prevention activities to mitigate further increases.

They asked for an increase in research focused on liver cancer, and urged for a greater priority to address the threat of liver cancer, the second deadliest cancer with a five-year survival rate of 20 percent. The Committee also noted that while more effective screening methods and treatments have lowered overall cancer incidence and death rates, several cancer types with particularly low survival rates have limited screening methods, and effective treatments for these cancers are also limited.

GLI Highlight:

  • This is positive news and shows clear support from the House of Representatives to preserve and create valuable programs within HHS agencies that protect liver health patient lives.

  • Even if this spending report is only a draft, it is still positive to see more emphasis put on funding liver health research.

  • 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.

  • GLI’s position also 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.

Liver Transplant Policy

The Washington Post Highlights Liver Transplantation Policy Issues

This past month the Washington Post once again put an important spotlight on the new liver transplantation policy.

According to the post, open conflict broke out among U.S. liver transplant centers, with doctors and patients in less populous parts of the country seeking a contempt of court order against the Health and Human Services Department and the nonprofit organization that runs the transplant system.

Hospitals and patients on the waiting list for livers in places such as Georgia, Michigan, Kansas, Missouri and elsewhere accused the government and the United Network for Organ Sharing (UNOS) of defying a judge’s order to temporarily halt a new way of distributing those organs for transplant.

The legal skirmish is the latest in a decades-long struggle over how to allocate valuable livers, kidneys, hearts, lungs and other organs in a country where demand for transplants far exceeds supply.

As a reminder, last December, UNOS revamped the system to allow patients within 500 nautical miles of a donor’s hospital to claim a liver. Patients and transplant centers in less populous parts of the country sued in April,saying the new rules would allow big-city hospitals — where demand is highest — to reach far into their regions to take livers.

They contend the new policy will cut their access to livers by 20 percent or 256 livers, resulting in more deaths among patients in those areas.

GLI Highlight:

  • 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. More emphasis should be placed on organ donation in metropolitan areas.

Liver Cancer

ACS-CAN and ASCO announce joint policy strategy for the 116th Congress

This past month the American Cancer Society Cancer Action Network (ACS-CAN) and American Society of Clinical Oncology (ASCO) announced their policy priorities for the 116th Congress.

The following specific goals were included in their list:

  • Increase Federal Funding for Research

  • Improve Cancer Care

    • Pass the Clinical Treatment Act (H.R. 913) to remove barriers for Medicaid patients to enroll in clinical trials.

    • Pass the Cancer Drug Parity Act (H.R. 1730/S. 741) to eliminate burdensome patient cost sharing for oral anticancer drugs.

    • Pass the Safe Step Act (H.R. 2279) to ensure patients with private insurance have reasonable protections against harmful step therapy (fail-first) practices.

    • Pass the Palliative Care Hospice Education and Training Act (H.R. 647) to increase workforce, promote education, and expand research on palliative care.

  • Protect Access to Needed Therapies

    • Tell CMS to reject proposed changes to Medicare Part D’s six protected classes and allowance for step therapy in Medicare Advantage plans, which threaten to remove important protections for patients with serious illnesses, including cancer.

    • Work with CMS to ensure any policy changes considered to the Part B drug program protect patients from large out of pocket cost and ensure the viability of practices of all sizes in all settings.

GLI Highlight:

  • GLI and ACS-CAN share many of the same policy priorities.

  • In the ACS-CAN 2019 Cancer Facts & Figures Guide they summarize the current standing for each type of cancer.

    • Liver Cancer is mentioned, and declared as the most rapidly increasing cancer in both men and women.

    • GLI will continue to work with ACS-CAN and ASCO to prioritize liver cancer.

  • Most importantly, GLI will continue to work with like minded organizations that push to protect patient access to needed therapies, and the funding of federal agencies that protect patient lives through the development of valuable new therapies.

U.S. Stateside

ACLU of Vermont and Harvard Law School File Class Action Lawsuit Challenging Denial of Lifesaving Hepatitis C Treatment to Hundreds of Vermont Prisoners

After years of advocating for Vermont prisoners to have access to life-saving medication for Hepatitis C Virus (HCV), the ACLU of Vermont and the Center for Health Law and Policy Innovation at Harvard Law School, with cooperating counsel James Valente, yesterday filed a class action lawsuit challenging the state’s refusal to treat hundreds of inmates diagnosed with chronic Hepatitis C. The case was filed in the federal district court in Burlington on behalf of two Vermont prisoners, Richard West and Joseph Bruyette, who seek to represent a class of inmates who have been or will be denied treatment without medical justification.

Please click here to find the full press release.


Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility. Funding available from NIH Application Deadlines: May 7th, 2021.



Congresswoman Doris Matsui (D-CA-6) - Congresswoman Doris Matsui has represented the City of Sacramento and its surrounding areas since 2005.  As a senior member of the House Energy and Commerce Committee, she serves on the Health, Environment and Climate Change, and Consumer Protection and Commerce subcommittees and is the Vice Chair on the Communications and Technology subcommittee. She has also expressed interest in being a champion for rare diseases including rare liver diseases.


The World Health Assembly (WHA) is the decision-making body of WHO, and is an annual gathering widely attended by delegations from WHO Member States around the world, including the countries of the European Region.


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