Liver Transplant Disparities
POLICY PERSPECTIVE
Six people die from waiting for a liver transplant every day. Currently, there are 13,192 liver patients in the U.S. waiting for a lifesaving transplant, ranking the country 5th in the world with more than a 50% lower donation rate than other countries such as Spain.
When looking at liver diseases like Nonalcoholic steatohepatitis (NASH) there are currently no approved treatments available. Liver transplantation is the only recourse for people with end-stage liver disease and/or NASH-related Hepatocellular Carcinoma (HCC). This is why NASH was the fastest-growing reason for liver transplantation between 2002 and 2011.
The need for healthy livers is rising. Patients deserve accountability on the front lines of organ donation, which is why we applaud the President’s Executive Order entitled “Advancing American Kidney Health,” which calls for the “establishment of more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance.”
Access to a new liver is a life-and-death situation. We are encouraged that the Administration, HHS, CMS, and Capitol Hill agree and acknowledge the role they can play in protecting patient lives and impacting positive change to the organ recovery system.
However, even with this meaningful momentum, patients still face significant challenges that many times do not receive attention.
Ethnic minorities comprise approximately 30% of all adult liver transplantations performed annually. High prevalence of comorbidities such as diabetes, hypertension, obesity, hepatitis B and C in minority groups, result in racial minorities being disproportionately represented on transplant waiting lists.
There are many barriers to patient referral to a transplantation center for evaluation. For example, the transplantation activation process is inadequate. In addition, the referral rate for African-Americans was disproportionately lower than their representation in the hospital population, in part, due to lack of health insurance. According to the National Healthcare Disparities Report, health insurance negatively impacts black and Hispanic patients.
As we move into 2020 and continue the positive efforts around reforming our broken organ recovery system, it is important to remember that there is no “silver bullet” to fix this immense problem. Modernizing and holding organ procurement organizations accountable is a critical initial step toward addressing our transplant waiting list and saving lives.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
“Request to Connect” - A New Way for Patients to Connect with FDA
The FDA Patient Affairs Staff has announced that the FDA “Request to Connect” portal is now live. This new patient portal provides patients and caregivers with a single entry point to the agency for questions and meeting requests.
Recommendations for Hepatitis C Screening Among Adults-2019; Request for Comment
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the opening of a public docket to obtain public comment on proposed new recommendations for hepatitis C virus (HCV) infection screening for adults, including pregnant women. The new recommendations are intended for U.S. healthcare providers and will include supporting scientific evidence of the effectiveness and economic value of screening to diagnose current HCV infection among pregnant women in the United States. Written comments must be received on or before December 27, 2019.
Prevent Cancer Advocacy Workshop
The Prevent Cancer Advocacy Workshop will be held on March 25, 2020 at the FHI 360 Conference Center in Washington, DC.
The Workshop is an annual event that convenes stakeholders to discuss pressing issues that impact cancer prevention and early detection, as well as novel approaches to address these issues through policy and advocacy. It is an open forum that allows participants to immerse themselves in engaging presentations and facilitated conversations, and to build capacity for creative solutions through collaboration with other attendees. Save the Date: Prevent Cancer Advocacy Workshop 2020.
POLICY DEVELOPMENTS AT GLI
GLI’s Advanced Advocacy Academy (A3) Inaugural Capitol Hill Advocacy Day
On October 31st 2019, the Advanced Advocacy Academy (A3) alumni participated in the Global Liver Institute’s inaugural A3 Capitol Hill Advocacy Day.
A3 alumni were successful in advocating for, and building support around, the LIVER Act by telling their personal “lived” experiences. In total, A3 alumni met with 12 congressional offices on both sides of the aisle and Capitol in relevant key committees, caucuses, and constituent states.
As a nonprofit patient advocacy organization committed to improving the lives of all impacted by liver disease, our organization was very excited to give A3 alumni the national platform to not only advocate for the LIVER Act, but also for liver disease awareness overall.
The LIVER Act of 2019 properly adjusts the priority of liver transplants within federal agencies and modernizes systems currently in place to better meet the unmet need of liver disease patients. This Act will rightfully establish a starting point for future efforts and give a voice to more liver disease patients who have been neglected for far too long.
We look forward to continuing to work with A3 alumni to advance not only this crucial piece of legislation but all liver disease policy to the top of the global public health agenda.
#OctoberIs4Livers Congressional Briefing - Liver Cancer Drivers and Disparities
On October 31st, Global Liver Institute collaborated with Congresswoman Nydia Velazquez (NY), and American Gastroenterological Association, Hepatitis B Foundation, Hep B United, AAPCHO, NVHR, and NASTAD to host an educational Congressional briefing entitled, "Liver Cancer Drivers and Disparities."
The briefing included an amazing panel moderated by GLI President and CEO, Donna Cryer. The panel was comprised of some of our nation’s leading voices in liver cancer. Clinicians, epidemiologists, and patient advocates including Dr. Richard Sterling MD from VCU Medical School and the American Gastroenterological Association; Dr. John Groopman Ph.D. from Johns Hopkins University School of Medicine; Tony Villiotti the President of NASH kNOWledge and a GLI A3 Patient Advocate and Valerie Green, an NVHR Patient Advocate.
The briefing acted as a closing event for GLI’s month-long awareness campaign, #OctoberIs4Livers. It educated Congressional policy staff about liver cancer, the key drivers of the disease, the steps needed to combat the most rapidly rising cancer since 1980, the gaps in public health infrastructure, and how response strategies must begin with modernizing the systems in place to better meet the needs of impacted populations.
It also included a key call to action to combat this rising epidemic. The LIVER Act of 2019, H.R. 3016, was introduced to help people of all ages, lifestyles, and ethnic backgrounds reduce their risk of liver cancer and related illnesses by enhancing the federal government’s research initiatives while empowering local entities to promote treatment and raise awareness.
The briefing was standing room only and took place in 122 Cannon House Office Building.
GLI Responds to AOPO's Recent Misinformation Campaign
In response to AOPO’s (Association for Organ Procurement Organizations) recent campaign which GLI found to contain factual errors, GLI sent this letter to HHS in support of the Administration's efforts to bring accountability to the organ procurement organizations' performance. Our letter provides factual corrections to AOPO's claims.
GLI also thanked HHS for the incredible progress made to date and for bringing actionable solutions to this issue so that patients and the public can have confidence that the transplant system works.
GLI Submits Letter to ICER on NASH Draft Scoping Document
The Institute for Clinical and Economic Review (ICER) is an independent organization that issues reports about how well certain diagnostic tests and new medications work, their relative value, and how much they should cost. Ultimately, health insurers, including government agencies around the world, use ICER reports to decide whether a medical test or treatment is worth the cost of covering it. Their methods are not without substantial controversy, particularly among patient and healthcare advocates. On October 30, 2019 ICER announced its intention to evaluate “the health and economic outcomes of treatments with obeticholic acid for NASH with fibrosis.” ICER outlined its review timetable which includes opportunities for input and comments.
GLI collaborated with the American Gastroenterological Association to submit a statement (within the 500 word limit ICER permits) and stressed that central to understanding the impact of NASH are 8 core issues:
Lack of public and clinician awareness of NASH
The intrinsic link to other diseases
NASH impact on quality of life
Unique issues at each stage of the disease
Challenges in diagnosing NASH
Risks of adverse outcomes including liver cancer
Lack of treatment options
Liver transplantation and complications
GLI looks forward to continuing to work with the NASH Council and ICER on a report that correctly captures the costs associated with this life-threatening disease.
An Important Step Toward Increasing the 5-Year Survival Rate of Liver Cancer Patients
The Global Liver Institute (GLI) has set a bold goal to double the five-year survival rate for liver cancer by 2030. GLI's President & CEO Donna Cryer discusses the state of liver cancer in the U.S. currently and how in partnership with the healthcare community, we aim to reach this goal in this article published in the American Journal of Managed Care.
NASH and Liver Cancer: The New Cancer Headline
Of the many causes of liver cancer, NASH has emerged as a significant contributor to this disease. GLI's President & CEO Donna Cryer connects the dots between NASH and liver cancer in this cover article in this month's American Journal of Managed Care's Evidence-Based Oncology.
GLI at AASLD
The Global Liver Institute Team participated fully across six days at the American Association for the Study of Liver Diseases Conference in Boston, Massachusetts, commonly known as The Liver Meeting(™).
We have been honored to advise and assist AASLD leadership and staff in implementing the patient engagement element of their strategic plan and proud that our team members have been selected for the following roles to ensure that the patient and medical community activities are aligned in shaping the liver health environment:
Donna Cryer, JD
AASLD Patient Advisory Committee, AASLD NAFLD Task ForceJeff McIntyre
AASLD Practice Guidelines CommitteeAndrew Scott
AASLD Policy Committee
GLI joins OCAN and Other Key Stakeholders on CMS Draft Core Set Sign-On Letter
As organization and individuals working to address the obesity epidemic through research, treatment, prevention and policy change, we wrote to the Chief Quality Officer & Director of the Division of Quality and Health Outcomes at CMS to express our opposition to removal of both the Weight Assessment and Counseling for Nutrition and Physical Activity for Children/Adolescents-Body Mass Index Assessment for Children/Adolescents (WCC-CH) in the Child Core Set and the Adult Body Mass Index Assessment (ABA-AD) in the Adult Core Set.
GLI Signs onto Letter Advocating for Finalizing FY 2020 NIH Funding
The signatories thanked the leadership of the House and Senate Appropriations committees for their longstanding support of the NIH, including support shown in the FY 2020 House-passed and Senate draft bills.
The letter encourages Congress to work quickly to complete the FY 2020 appropriations process with robust funding for the NIH, noting, “In passing the Bipartisan Budget Act of 2019, Members of Congress recognized that our nation’s defense and nondefense discretionary priorities could not be fully realized under the original Budget Control Act statutory caps. In light of the budget agreement that increased the non-defense discretionary caps by nearly $25 billion over FY 2019, we believe that supporting NIH research as part of a thriving public health continuum should continue to be a top national priority. The allocation for the final FY 2020 Labor-HHS-Education spending bill should reflect that commitment.”
GLI Signs onto Letter Urging Congressional Conferees to Increase Funding for Domestic HIV and Related Programs
The linked letter urged Congressional conferees to include final funding levels for ABAC’s programs at the highest levels (generally those proposed by the House of Representatives) and to reject funding cuts proposed by the Senate, particularly for HOPWA.
While both the House and Senate have fully funded the Ending the HIV Epidemic Initiative, the House has proposed increased funding for many other domestic HIV and related programs and removed restrictions on funding for syringe service programs. We also are asking that Congress include the Ending the HIV Epidemic Initiative as an anomaly in the case that further Continuing Resolutions are required.
GLI Joins PIPC and 50 Other Patient Advocacy Organizations in Submitting a Letter to ICER on 2020 Value Assessment Framework
On Friday, Oct. 18, the Partnership to Improve Patient Care joined over 50 leading patient advocacy groups in submitting a joint comment letter to the Institute for Clinical and Economic Review (ICER) on it’s draft 2020 Value Assessment Framework. The letter criticized ICER for defending its use of the QALY, stating that ICER’s framework ignores ethical principles that enjoy broad support among the general public. Instead of relying on metrics that treat patients as averages, the letter encouraged ICER to abandon it’s use of discriminatory value metrics and develop mechanisms that incorporate robust patient and clinician feedback. “Above all, we urge ICER to put patients and people with disabilities at the center of all of your assessments,” the letter states. “ICER’s value assessments do not promote affordability for patients, but instead give payers justification to create barriers to treatment coverage that benefit their own bottom line.”
GLI Signs onto FY2020 Conference Committee Sign-on Letter
In preparation for the convening of a conference committee to reconcile House and Senate appropriations bills, GLI and the Hepatitis Appropriations Partnership (HAP) advocated for FY2020 funding levels closer to the House totals.
GLI Signs Onto Letter urging HHS to Initiate a Living Organ Donation Public Awareness Campaign
The letter advocates for collaboration between HHS and a new umbrella group of living organ donor-led organizations (the National Donor Alliance) with the assistance of other organ donation and transplantation stakeholders.
The campaign would use donor drives for individual patients to tell a compelling story about transplants. This would take place in concert with outreach by community groups to which these patients belong. For example, one of the spotlighted patients might be a veteran, and we would work with veteran support groups to spread the message about their need for a living donation. This would be an engaging story with which to educate the public about objective facts of donation while hopefully saving lives with additional transplants.
GLI joins OCAN on Letter to the USP in Response to the USP’s Request for Comments Regarding USP’s Proposed Version 8.0 of the Medicare Model Guidelines (MMG)
The letter urges the USP to update the MMG to include the class language from the USP-DC surrounding anti-obesity agents (both single entity and combination drugs) should the Treat and Reduce Obesity Act (TROA) be signed into law.
GLI Signs onto Letter for Health Extenders Negotiations and Letter in Support of the PCORI Reauthorization Act of 2019
GLI, along with many other organizations, sent a letter to the leadership of the Senate Finance Committee and the leadership to the House Energy and Commerce Committee and the House Ways and Means expressing our continued support for a long-term reauthorization of PCORI. The letter highlights the important impact PCORI has on our health care system, specifically noting its value to older adults and the Medicare population. The letter also expresses concern about what the lack of new funding and the uncertainty surrounding short-term extensions will mean for PCORI's ability to fund new research and the negative impact it will have on their ability to manage programs and ongoing operations.
A letter was also sent to the Senate bill sponsors in support of the inclusion in the “Patient Centered Outcomes Research Institute Reauthorization Act of 2019” of a 10-year reauthorization period, maintenance of the current funding mechanisms, and continuation of the mandate to conduct comparative clinical effectiveness research.
FOR YOUR CALENDAR
American Epilepsy Society (AES) Annual Meeting Dec. 6-10, Baltimore
61st Annual American Society of Hematology Annual Meeting Dec. 7-10, Orlando
ASCO GI Cancers Symposium, Jan. 23-25, 2020, San Francisco
3rd Swiss Autoimmune Liver Disease Meeting, March 13-14, 2020, Lugano
EASL International Liver Congress, April 15-19, 2020, London
GLOBAL NEWS
NEW Approved European Commission (2019-2024)
Members gave the green light to the whole new European Commission during the plenary session in Strasbourg on the 27th of November.
The commission was approved - with 461 votes in favour,157 against, and 89 abstentions. A total of 707 members voted.
Obesity Now Recognized As A Chronic Disease In Italy
This collaborative, multi-stakeholder effort was long in the making and includes a Charter of Human Rights for People Living with Obesity. The document enumerates actions necessary for the protection of health for obesity prevention and treatment of people living with obesity.
A Dream Machine – The EU Health Programme Turns Ideas into Actions that Benefit EU Citizens
The Health Programme is a funding instrument that supports the development and implementation of health policy and encourages innovation in health. However, calling it a funding instrument doesn’t really do it justice – it’s more of a lifeline. The Health Programme supports national authorities and health actors to help prevent citizens from becoming ‘patients’ through health prevention and promotion and protection. It supports European Reference Networks to help people with rare diseases to get the diagnosis and care they need, and it protects all of us by supporting surveillance at points of entry and the rapid identification of rare pathogens.
The Programme also helps the Member States – it co-funds public health interventions and novel initiatives at local, regional and national levels, so that good ideas can be turned into good practices and those good practices can then be shared across Europe.
Marketplace workshop on best practices for healthy and sustainable food systems (reducing mortality due to non-communicable diseases)
A marketplace workshop showcasing best practices for healthy and sustainable food systems and practices conducive to reaching Sustainable Development Goal 3, target 3.4 (reducing mortality due to non-communicable diseases) took place in Brussels on 20 June 2019. Representatives from EU Member States had the opportunity to receive information about best practices, which have been selected after open calls for best practices run via the best practice portal. The practices presented were assessed as “best” against the criteria adopted by the Steering Group on Promotion and Prevention.
U.S. NEWS
U.S. Federal Budget Update
On November 21st, President Trump signed the Further Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (H.R. 3055), a continuing resolution (CR) that temporarily extends the FY 2019 funding levels for discretionary spending, including the NIH, through December 20. The House passed the measure, 231-192, on November 19, followed by Senate passage by a vote of 74-20 on November 21.
The legislation averts a government shutdown, as none of the FY 2020 spending bills have been signed into law. The legislation is the second CR since the fiscal year began October 1. Congressional leaders still lack a clear fiscal 2020 funding plan beyond Dec. 20, with protracted fights over the president's border wall impeding progress on full-year appropriations bills and impeachment proceedings threatening to consume Congress through January.
U.S. House of Representatives Speaker Releases Drug Pricing Plan
Recently, House Speaker Nancy Pelosi presented a Democrats drug pricing plan, calling for Medicare to negotiate prices on at least 25 medicines, with an option for commercial insurers to take advantage of the deals.
This past month, a key progressive amendment remained in the package. The amendment, added in the House Education and Labor Committee's markup would require the government to examine the possibility of rebates for employer-sponsored health plans when a drug company raises the price of medicine faster than inflation.
Democratic leaders are hoping to bring the bill to a floor vote as early as the first week of December.
Proton Beam RT Doubled OS in Unresectable Liver Cancer
Ablative radiotherapy (RT) using proton beam technology more than doubled overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC) compared with standard photon beam radiotherapy in a small group of patients treated at a single institution, a retrospective study found.
Genentech’s Atezolizumab (Tecentriq) in Combination With Bevacizumab (Avastin) Increased Overall Survival and Progression-Free Survival in People With Unresectable Hepatocellular Carcinoma
Genentech announced that the Phase III IMbrave150 study, evaluating Tecentriq ® (atezolizumab) in combination with Avastin® (bevacizumab) as a treatment for people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy, met both of its co-primary endpoints demonstrating statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared with standard-of-care sorafenib.
GRANT OPPORTUNITIES
Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility. Funding available from NIH Application Deadlines: May 7th, 2021.
Conquer Cancer®, the ASCO Foundation, has awarded more than $126 million through nearly 2,100 grants and awards to medical students, trainees, young scientists, and oncologists at all stages of their careers. Many of their funding opportunities are currently accepting applications. While eligibility criteria differ for each award, all grants require that applicants be a member of ASCO to apply. Join ASCO and to submit a grant application.
NAMES TO KNOW
Senator Tammy Duckworth is an Iraq War Veteran, Purple Heart recipient and former Assistant Secretary of the Department of Veterans Affairs. She was among the first Army women to fly combat missions during Operation Iraqi Freedom. She was elected to the U.S. Senate in 2016 after representing Illinois’s Eighth Congressional District in the U.S. House of Representatives for two terms.
TERMS TO KNOW
Continuing Resolution - In the United States, a continuing resolution (often abbreviated to CR) is a type of appropriations legislation. An appropriations bill is a bill that appropriates (gives to, sets aside for) money to specific federal government departments, agencies, and programs.