On March 30, 2023, a judge in the U.S. District Court in the Northern District of Texas issued a final judgment in a court case challenging the Affordable Care Act’s (ACA) requirement that private health insurance plans cover preventive services without cost-sharing for their enrollees. In this judgment, Judge Reed O’Connor held that services recommended by the U.S. Preventive Services Taskforce issued since March 2010 as they pertain to the ACA coverage requirements are unlawful.
Coverage requirements for vaccines recommended by Advisory Committee on Immunization Practices (ACIP), women’s health services recommended by Health Resources Services Administration (HRSA), and certain services for children and adolescents recommended by Bright Futures, a national health promotion and prevention initiative, are not impacted. The most significant impact for liver disease is on screening for hepatitis B and C, which would be no longer required covered services. Additional impacted services include diet counseling, obesity screening for children and adolescents, and weight loss behavioral health interventions to prevent obesity-related morbidity and mortality in adults. The loss of these services would be detrimental for many people living with liver disease, particularly NASH patients and other patients with specific dietary needs. Plans may choose to cover these preventative services, but they will be permitted to impose cost-sharing.
The U.S. Department of Justice (DOJ) has already filed an appeal with the 5th Circuit Court. If the 5th Circuit Court affirms the lower court, the case would have to be appealed to the Supreme Court. The DOJ asked a federal district judge in Texas to stay the March 30 decision, vacating the preventive services coverage mandate as the case winds its way through the courts. GLI strongly supports the ACA’s requirement of private plans to cover preventive services and is following this case closely.
This decision, if held in the higher courts, will impact people’s access to care, worsen health inequities, and will end up costing more overall in health care spending. Over time, millions of people could end up paying more out of pocket for preventive services, and many will lose access to certain services altogether. These effects are concerning for all Americans, but are particularly concerning for patients living with liver disease. GLI continues to advocate for equitable policies to prevent liver disease and promote liver health.
Policy Developments at Global Liver Institute
GLI Calls for Robust Engagement of Patients in Implementing the Medicare Drug Negotiation Program
Global Liver Institute joined organizations representing patients and people with disabilities in comments to the Centers for Medicare and Medicaid Services (CMS) calling for robust patient engagement in its implementation of the Medicare Drug Negotiation Program. Three letters, signed by a total of 174 organizations, were sent to CMS. GLI looks forward to being an engaged partner with CMS as the agency negotiates payment for treatments that may impact people with liver disease and liver cancer.
GLI urges cosponsorship of H.R. 2544, Securing the U.S. Organ Procurement and Transplantation Network Act
The bill is a bipartisan response to the urgent need for reforming the Organ Procurement Transplantation Network (OTPN), breaking up the national monopoly contract so that the HRSA can run an open, competitive process and choose from the best of the best in each field (e.g., health policy, IT, logistics, patient safety), thereby saving more lives.
Donna R. Cryer, JD, founder and CEO of Global Liver Institute and 28-year liver transplant survivor, wrote an opinion piece about this issue alongside other people who have experienced a transplant and whose loved ones are impacted. She testified in 2021 in the House Oversight and Reform Committee in support of bipartisan efforts to make the organ procurement system more accountable. Now that HRSA is moving toward modernization, it is imperative to ensure a truly competitive process that allows HRSA to choose from the best contractors for different national OPTN functions.
GLI Strongly Supports the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
H.R. 2407 recognizes advances in the fight against cancer by modernizing the Medicare program and creating a benefit category for multi-cancer early detection tests, which allows CMS to initiate an evidence-based coverage process for multi-cancer tests upon FDA approval.
ICER MIDWEST CEPAC WORKS TO KEEP UP WITH INFORMED NASH PATIENT ADVOCATES
Patients point out numerous flaws in ICER model and understanding of disease
May 1, 2023, Washington, DC – On Friday, the Institute for Clinical and Economic Review (ICER) held a public hearing to review its draft assessment of Resmetirom and Obeticholic Acid (OCA) for Non-Alcoholic Steatohepatitis: Effectiveness and Value. While the evidence presented for both drugs was deemed effective in fibrosis regression, ICER inconsistently voted to show that there was only a net health benefit in favor of resmetirom, being superior to lifestyle management alone, and not in OCA.
ICER’s voting questions and assumptions failed to reflect the complexities of the NASH patient experience. Donna R. Cryer, JD, President & CEO of Global Liver Institute and 28-year liver transplant survivor said, “ICER has conducted a fundamentally flawed review based on faulty assumptions and oversimplifies a complex disease and the existing data.”
NASH Patients’ 5 top takeaways from the ICER Meeting:
“We’re not brand new” – NASH patient Kimberly Martinez emphatically stated to ICER Policy Roundtable members. Barriers to care in the form of step therapy and cumbersome documentation of repeated attempts at weight loss, delaying care, and allowing people to get sicker will not be tolerated by the advocacy community once FDA-approved therapies for NASH are available.
Cardiovascular side effects were weighed heavily by members of the Midwest CEPAC, even if those effects were manageable by statins and for an uncertain duration.
Few Midwest CEPAC members voted to recognize caregiver impact despite NASH patient caregiver, support group leader, and co-founder of NASH KNOWLEDGE, Betsy Villotti’s stirring testimony that families are “being held hostage by liver disease” as their loved one descended into hepatic encephalopathy and other NASH complications.
ICER wants to have it both ways – rushing to do their review before outcomes data, long-term studies, prices and other essential elements of an accurate model are available. Then, they cast doubt and lowered their scores and grades for lack of robust data.
ICER president Steve Pearson conjured the dark days of Hepatitis C restrictions and offered several utilization management scenario options to Policy Roundtable members. This should not be the case study to follow and instead should serve as a cautionary tale when even today, years after approval of an innovative cure, only about 1 in 3 individuals with Hep C with insurance get timely treatment and people with Medicaid were 46% less likely to receive treatment. Unnecessary loss of life, particularly among the most vulnerable should not be our goal, as discussed in the recent JAMA article by Special Advisor to the President, Dr. Francis Collins.
Advocates’ deep familiarity with the existing data and recently published NASH Clinical Care guidelines and guidances was evident, a level of knowledge that few on the committee possessed. Despite the diverging opinions of the physician and expert panelists within the committee, the unwavering voice of the advocates throughout left a united message emphasizing the importance of a suspension or reduction of disease progression giving the liver more time, and providing patients, clinicians, and researchers a better chance to combat NASH.
GLI is a patient-founded and led 501(c)3 nonprofit organization committed to liver health which focuses on advancing patient-centered research, education, and care delivery models for those living with NAFLD/NASH. Global Liver Institute’s NASH Council, which launched in 2017 at the Milken Institute at the George Washington School of Public Health coalesces a diverse set of more than 80 stakeholders around the urgency for developing preventive, diagnostic, and treatment solutions for all stages of NAFLD and NASH in the U.S. and abroad. GLI equips advocates to identify and solve the problems that matter to liver patients. Follow GLI on Facebook, Instagram, LinkedIn, and YouTube.
PATIENT GROUPS DECLARE ICER REVIEW OF NASH MEDICATIONS CAUSES MORE UNCERTAINTY AND CONTROVERSIES THAN IT RESOLVES
Lack of Data and Faulty Assumptions Weaken Usefulness of ICER Recommendations
April 28, 2023, Washington, DC – Today, the Institute for Clinical and Economic Review (ICER) will hold a public hearing on its draft assessment of Resmetirom and Obeticholic Acid for Non-Alcoholic Steatohepatitis: Effectiveness and Value. Patients from around the United States and Canada will participate in the public meeting, convened virtually by the Midwest Comparative Effectiveness Public Advisory Council (CEPAC).
Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease. NAFLD is a chronic progressive condition of which NASH is the more advanced form, where the extra fat turns into inflammation (swelling) and fibrosis (scarring) of the liver. If severe enough, NASH can lead to cirrhosis, cancer, the need for a transplant, or death. Diagnosis and treatment of NASH are imperative to stem these more serious outcomes. ICER’s modeling and analysis demonstrate a serious mischaracterization of the disease and of the potential benefit to patients who do not currently have any FDA-approved medications.
ICER should give serious consideration to the input of the patient community provided today during the public comment session and policy roundtable in addition to those which have already been shared during GLI’s NASH Externally Led Patient-Focused Drug Development Meeting meeting in 2021. We request that ICER fully integrate patient perspectives on the weights of various health states and the preferences for different combinations of side effect profiles in the context of their disease into their final evidence report, while also factoring them in when making policy recommendations. Additionally, we appeal to the ICER Midwest CEPAC voting panel to carefully consider these comments and their vote to reflect sound science and reality-based medical practice.
Donna Cryer, President & CEO of Global Liver Institute and 28-year liver transplant survivor said, “NASH is a chronic, progressive illness. That is not a scientific debate. What is uncertain is who is a fast progressor, the rate of progression, and the relative contributory factors of various drivers or comorbidities in the disease progression of any one individual. The ICER model does not effectively capture this.”
Other flaws in the ICER model and review around mischaracterization of the disease, misinterpretation of the placebo groups, intermixing of US and EU quality of life and cost data, and myriad other faulty assumptions and limited data undermine the validity of the review and any recommendations that follow. GLI calls on ICER to take these patient experiences seriously in its evaluation in the final assessment of resmetirom and obeticholic acid for the treatment of NASH. Approval of and access to these initial effective NASH treatments is essential to our community and to encourage continued innovation in what is now a very robust field of research.
In addition to Global Liver Institute, representatives from GLI Liver Action Network (LAN) members presenting at the ICER Public Hearing on April 28 include Fatty Liver Alliance, Fatty Liver Foundation, and NASH kNOWledge. Through collaboration and innovative initiatives, GLI and LAN members work to solve problems that matter to patients and families, improving the health of communities.
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GLI is a patient-founded and led 501(c)3 nonprofit organization committed to liver health which focuses on advancing patient-centered research, education, and care delivery models for those living with NAFLD/NASH. Global Liver Institute’s NASH Council, which launched in 2017 at the Milken Institute at the George Washington School of Public Health, coalesces a diverse set of more than 80 stakeholders around the urgency for developing preventive, diagnostic, and treatment solutions for all stages of NAFLD and NASH in the U.S. and abroad. GLI equips advocates to identify and solve the problems that matter to liver patients. Follow GLI on Facebook, Instagram, LinkedIn, and YouTube.
After a whirlwind winter, the first quarter of 2023 has come to a close! We’ve glimpsed promising horizons in the NASH treatment world, received big news for liver transplantation equity and transparency, and have led conversations on technological advancements, access to healthcare, and maternal health in liver disease. We can’t wait to see what the rest of the year has in store!
GLI around the World
Instituto Nacional de Ciencias Médicas y Nutrición, México As part of our commitment to building engagement and infrastructure that benefits liver health across the globe, GLI’s Donna R. Cryer and Jeff McIntyre joined with Mexican state health ministers and Dr. Arun Sanyal (VCU) and Dr. Sitaramaraju Yarramraju (Avant Santé) at the Instituto Nacional de Ciencias Médicas y Nutrición in Mexico City on January 23-24. They discussed the rise of liver disease as part of the overall rise of metabolic disorders in Mexico.
National Forum, Bulgaria On February 15, GLI’s Liver Health is Public Health program director Giacomo Donnini spoke at a National Forum, organized by HepActive, in Bulgaria, entitled “Where is Bulgaria on the way to meeting the global health goals of eliminating viral hepatitis by 2030?” Donnini shared key findings about liver health globally – and particularly in Bulgaria – gathered from our Global State of Liver Health report.
Global NASH Congress, London, UK On March 2, VP of Liver Health Programs Jeff Mcintyre represented GLI at the 6th Global NASH Congress in London. In his panel, titled “A Solution for Every Stage: The NAFLD/NASH Patient,” Jeff emphasized the importance of patient involvement in all areas of the NASH field, along every stage of the patient journey.
Policy & Advocacy
GLI and Thorn Run Partners We are pleased to share that we have partnered with Thorn Run Partners (TRP) to provide us with their public policy expertise. We look forward to working with their team of experts in moving policies forward that will benefit the broader liver health community.
GLI CEO Provides Public Witness Testimony to US House of Representatives Appropriations Committee, Labor/HHS Subcommittee GLI’s CEO Donna R. Cryer provided a public witness testimony to the Labor/HHS Subcommittee of the US House of Representatives Appropriations committee regarding funding for a breadth of liver health issues, including the rise of NASH, funding the hepatitis C elimination program and hepatitis B vaccinations, and directly funding agencies to address liver cancer, including the CDC, NIH, and NIDDK. Read the statement.
Global Liver Institute Applauds HRSA’s Announcement of OPTN Modernization Initiative and Contract Break Up as Critical to Achieve Health Equity Health Resources and Services Administration (HRSA) recently announced that it will break up the Organ Procurement and Transplantation Network (OPTN) monopoly in order to improve accountability and transparency in the organ donation system. GLI applauds this action as critical to equity in organ allocation, improved organ recovery and transportation and responsible use of OPTN funds, which are largely provided by listing fees from patients themselves.
NASH
Comparing Clinical Care Guidelines in NAFLD/NASH Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease globally, affecting 1 in 4 people. Currently, there are no U.S. Food and Drug Administration-approved medications for the treatment of NAFLD or NASH. In an effort to manage this growing disease, the AGA, AACE and AASLD developed evidence-based clinical practice guidelines that highlight recommendations for screening, diagnosis and management of NAFLD and NASH, which we have compared and contrasted.
International #NASHday will be on Thursday, June 8, 2023! Entering its sixth year, we invite you to step up for patients, step up for early detection, step up for advocacy, and #StepUpforNASH as part of this year’s International NASH Day.
World Cancer Day with the Minnesota Legislature, Minnesota On February 7, GLI’s Director of Liver Cancers Programs Sarah Manes advocated alongside the Minnesota Cancer Alliance at the state capitol on World Cancer Day to call the legislature to pass for smart policies that will save lives through prevention, early detection, and accessible treatment for cancers.
Society of Interventional Radiology’s (SIR) Annual Scientific Meeting, Phoenix, AZ On March 8, GLI CEO Donna R. Cryer discussed with delegates in interventional radiology about the patient experience and what patient-centered steps are necessary to move the liver cancer path forward at the closing plenary session of the SIR Annual Meeting.
Pediatric & Rare Liver Diseases
Rare Liver Diseases Month The 2023 Rare Liver Diseases Month and concurrent #RareAware campaign was a success! By focusing on pregnancy and parenthood, we raised awareness of the rare liver conditions that can affect or even develop during pregnancy or in the first few days of a baby’s life, convened experts to identify steps forward to support families who face liver disease, and even released new patient education materials.
Rare Disease Day: A Look at 40 Years of the Orphan Drug Act In recognition of Rare Disease Day, GLI’s CEO Donna R. Cryer provided the patient perspective during a Rare Disease panel, held on February 28, recognizing the 40th anniversary of the Orphan Drug Act, put on by The Hill and moderated by Bob Cusack, The Hill’s Editor in Chief. Watch the full panel.
Updates from the Liver Action Network (LAN)
GLI’s Liver Action Network Emphasizes the Link between NASH and Obesity on World Obesity Day The LAN pledges collective support of World Obesity Day to acknowledge the strong connection between NASH and obesity. Read more.
GLI’s Liver Action Network Supports Living Donor Day and Urges for Increased Awareness of Living Donation The LAN pledges collective support of living donors, families, recipients, and clinical teams who make lifesaving liver transplants possible and urges Congress to pass legislation to support and protect those who would like to become living donors. Read more.
Your contributions help us ensure that liver health is discussed and prioritized by leaders around the world, each and every day! Consider making a donation to support the work of GLI and our advocates.
Value-based healthcare is a payment model for delivering healthcare in which providers (including clinics, hospitals, and more) are paid based upon conditions, episodes, outcomes, and overall health rather than being paid a fee for each service provided.
Often the distinction between in-network and out-of-network can be confusing. An in-network facility can house an out-of-network provider, which means little to no coverage and high costs. A change in insurance might block access to a doctor you’ve had for years – or make them a costly option.
Clear “pathways” or trained navigators from health plans can help you know what is covered, and when, through your specific plan.
Though the pharmaceutical supply chain has become complex and convoluted, innovative business models are emerging that reduce prices for patients reliant on drugs – such as transplant recipients who rely on immunosuppressants to keep them alive.
While affordability of and access to healthcare is important issues to you as a patient, it is also valuable to your employer to invest in your long-term health.
Because employers don’t necessarily know the full impact of their decisions about coverage, advocacy as an employee is important to ensure you and are able to access the care you need.
As employers design their health plans, they are investing more in prevention and primary care to reduce ill health and expensive hospitalizations downstream.
When encountering any obstacles with bills or coverage, it is critical for you to reach the right person – a stakeholder within an employer or insurance company that has the authority and the incentive to help.
You are the expert in your own experience – and there are many resources with helpful information and advocacy organizations excited to partner with you as you advocate in the insurance world.
Experience navigating the insurance system as a patient means that you can provide key insight and feedback in generating innovative solutions in healthcare coverage.
To learn more, watch the full A3 Payer Summit recording here:
Organ transplants are gaining more and more attention in the news, and there is little wonder why. In 2022, a total of 42,800 organs were transplanted in the U.S., yet thousands of people still die each year while on the transplant waiting list. According to The Health Resources and Services Administration (HRSA) a new person is added to the transplant waiting list every 10 minutes. Despite high need and long waiting lists, many viable organs go to waste far too often. All signals point to a system in desperate need of improvement.
Global Liver Institute’s (GLI) founder and CEO, Donna R. Cryer, JD, called for bipartisan reform of the broken transplant system in 2020, testifying in 2021 at a hearing of the U.S. House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy in its bipartisan pursuit of accountability and better performance from the organizations responsible for procuring life-saving organs for transplant. GLI also joined other advocacy organizations asking CMS to make an initial step in remedying the issue by substituting the metrics by which Organ Procurement Organizations (OPO) are evaluated for a new verifiable metric that is not open to self-reported interpretation and similarly supported a letter from Senators and Representatives calling on regulators to take measures to oversee and improve OPO performance in the interim given the lives at stake and equity implications.
In response to this collective advocacy, HRSA recently announced the Organ Procurement and Transplantation Network Modernization Initiative, which aims to update the existing donation database, contract more organizations to share the burden of the responsibilities that are currently managed solely by UNOS, and increase investment in organ procurement and transplantation.
GLI commends HRSA’s latest announcement. This initiative is a significant step in the right direction, however HRSA’s proposed changes do not directly address the issues of organ availability and efficient delivery, which are paramount to improving equity and access. As the U.S. organ transplant system is modernized, GLI will continue to focus our efforts on improving equity and access to organ donation and transplantation.
Donna R. Cryer, JD President & CEO Global Liver Institute
Policy Developments at Global Liver Institute
Appropriations public testimony
GLI CEO Donna R. Cryer submitted a public witness testimony to the U.S. House of Representatives’ Appropriations Committee, Subcommittee on Labor, Health and Human Services and Related Agencies requesting that U.S. Congress direct funds to combat the rising incidence of liver disease and liver cancers. In this testimony, Mrs. Cryer discussed combatting the nonalcoholic steatohepatitis (NASH) epidemic, advancing the hepatitis C elimination program, increasing vaccinations for hepatitis B, and directing funding to agencies to address liver disease and liver cancer.
GLI provides public comment on the Institute for Clinical and Economic Review’s (ICER) Resmetirom and Obeticholic Acid for NASH draft evidence report.
In response to GLI’s comments, ICER has invited patient advocates to speak at their upcoming NASH public meeting to provide their thoughts on the drugs under review and reactions to the ICER report findings, and to discuss the impact of NASH on patients’ lives.
GLI LIVE: Organ Procurement Advocacy for Improved Transplantation & Liver Health
Yesterday, Donna R. Cryer was joined by guest Greg Segal, co-founder of Organize, a non-profit patient advocacy group that works to increase the number of transplantable organs every year, to discuss organ donation, transplantation and more. With the ongoing discussions following HRSA’s announcement that it will modernize the OPTN, it is a critical time to consider this important aspect of liver transplantation. Watch the GLI LIVE episode here.
Make sure to catch more episodes of GLI LIVE as part of our Donate Life month series every Wednesday at 12:00pm ET live on LinkedIn, Facebook, and YouTube.
GLI’s Liver Action Network Supports Living Donor Day and Calls for Increased Awareness of Living Donation
Today, April 5, is Living Donor Day. The members of the Liver Action Network (LAN) pledge collective support for Living Donor Day to honor the donors, recipients, families and caregivers, and clinical teams that make the lifesaving gift of organ donation possible. In connection with this pledge, the members of the LAN urge U.S. Members of Congress on Capitol Hill to support Living Donor Day and vital pieces of legislation such as the Living Donor Protection Act (S. 511/H.R. 1255).
GLI’s Liver Action Network is proud to support Living Donor Day. As representatives of the liver health community, we call upon local and national governments to enact policies that help eliminate barriers for both living donors and recipients and to take steps to ensure living donors are protected. Despite the existence of the federal Living Donor Protection Act bill (S. 511/H.R. 1255) and Living Donor Protection Acts in several states, there is still a need for significant progress to eliminate barriers to organ donors and recipients. Potential donors are often discouraged from donating due to financial realities, such as a possible loss of health coverage or an increase in premiums. In addition, living donors might risk losing their employment during their recovery period. It is critical that governments in the U.S. and abroad look to implement policies that protect individuals willing to save someone’s life by donating living tissue, like liver.
The LAN fully advocates for policies that make the process of living organ donation easier. Eliminating barriers will allow more individuals to become living organ donors and is the first step in addressing this global organ shortage crisis.
Liver Action Network Members:
Global Liver Institute Arizona Liver Health Community Liver Alliance Empire Liver Foundation Fatty Liver Alliance Fatty Liver Foundation Liver Coalition of San Diego Liver Health Foundation Midsouth Liver Alliance NASH kNOWledge Northeast Ohio Liver Alliance Texas Liver Foundation
About Global Liver Institute
Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. Follow GLI onFacebook,Instagram,LinkedIn, andYouTube.
In the rare liver disease space, education for healthcare providers and researchers is just as important as awareness, patient and caregiver education, and patient advocacy.
First administration of gene therapy clinical trial for Wilson’s Disease completed at Yale New Haven Health
Wilson’s disease is a rare genetic disorder that causes copper to accumulate in the body, leading to liver and neurological damage. A gene therapy clinical trial that uses a virus to deliver a corrected version of the gene that is defective in Wilson’s disease was administered to the very first patient. Early results suggest that the therapy is safe and well-tolerated. If successful, this approach could offer a promising new symptom management option for patients with Wilson’s disease.
Gaining momentum for liver care: Arun Sanyal reflects on the VCU liver institute’s first year
The newly established Liver Disease and Metabolic Health Institute at Virginia Commonwealth University (VCU) presents significant opportunities for teaching and learning in liver disease. Since December 2021, the Institute has focused on transformative innovations in the prevention, diagnosis, and treatment of liver disease, with the ultimate goal of improving patient outcomes. In its first year, the Institute has already begun to make progress and its leadership looks forward to expanding its educational offerings to encompass the rare liver disease landscape in the future. We are excited to see what’s next for the VCU liver institute and hope that other institutions will follow suit in prioritizing research in liver disease.
Total robotic liver transplant surgery saves 8-month-old toddler
In Mumbai, a complete robotic liver transplant was performed at the Global Hospital on an 8-month old with Crigler Najjar Syndrome. The complete robotic surgical system provided high precision and control – which allowed for a reduction in blood loss, lower risk of infection, and less postoperative complications. The child was discharged only 3 days after the relatively quick transplant. Robotic surgery can be effective at all ages for liver transplant and may be considered for other organs as well.
Genethon given PRIME status by EMA for gene therapy to treat Crigler-Najjar Syndrome
The Europeon Mediciens Agency has granted the drug GNT-0003 as a PRIME or Priority medicines status as of March 7, 2023. This is currently the only clinical trial and drug that has been shown to have significant therapy on Crigler-Najjar syndrome, a disease that affects the levels of bilirubin in the blood. Severe cases can lead to neurological damage and death. As a rare liver disease, it is essential for physicians to learn about the disease and access ways for patients to manage their disease.
It’s not only important to GLI to keep you updated; we value your input and updates. This is a reminder to Liver Cancers Council members and supporters to share news to be featured in our monthly newsletter or on our Liver Central website.
Patient Burnout
A recent article published by TIME magazine discusses how patient burnout is a result of the structure of the U.S. healthcare system. The main factors contributing to patient burnout include long wait times, short doctors appointments, financial barriers, and the insurance system. This includes the “patient administrative burden” which refers to managing administrative tasks, appointments, and paperwork. A study conducted in 2021 concluded that these administrative tasks create burdens, leading to delayed and/or foregone care. Nine times out of ten, the patients are typically blamed for burnout. The overall patient experience is not positive and can discourage patients from seeking the medical care they need.
AI and Liver Cancer
Artificial intelligence (AI) is on the rise in healthcare. Recently, there have been two advancements in the cancer field with the use of AI. One is a new medical imaging platform called iBiopsy, where AI can detect information from imaging that typically cannot be seen from the human eye. With this technology, there could be earlier cancer diagnoses. In addition, AlphaFold, an AI-powered protein structure database, was used to develop a potential treatment for hepatocellular carcinoma (HCC) in just 30 days by University of Toronto researchers and Insilico Medicine. The AI system can also predict cancer survival rate from reading doctor’s notes. These are just a few of the amazing ways AI has been at the forefront of cancer research.
Reinventing Liver Cancer Education
Liver Central was created by GLI to equip everyone affected by liver cancers. We know that learning, advocacy, and collaboration empower us to create change in the exam room, in the community, and beyond. Whether you are a new patient, an experienced patient, a caregiver or a physician, visit https://livercentral.org to engage and learn more!
Spread the Word to Attend the Final HEPATIC Workshop in New York City
Sarah Manes, GLI Liver Cancers Program Director, and Cindi Cantril, MPH, RN, will be speaking about the importance of patient and caregiver advocacy and the role of the nurse navigator within the multidisciplinary HCC care team at this workshop, hosted by France Foundation. Please help spread the word for your New York contacts to attend this important training.
At GLI, we believe in creating solutions for patients at every stage of their care pathway. With the many advances in the field of NASH, whether it is access, clinical trial design, or drug pricing, we must be at the forefront of change in order to ensure patient voices and priorities are heard and incorporated.
The NAFLD/NASH Patient Perspective at Global NASH Congress
GLI’s VP of Liver Health Programs, Jeff McIntyre, presented the closing keynote session at the 6th Annual Global NASH Congress. McIntyre discussed the NAFLD/NASH patient journey and the importance of patient empowerment and inclusion in the field – including clinical trial development, protocol review, at-risk strategies, and the regulatory process.
Using GLI’s Global State of Liver Health report as an example, this presentation moved NASH from a niche to a global concern. It is vital that patients and medical professionals work together in order to develop solutions for each stage of the patient journey.
Intercept Announces FDA Advisory Committee Meeting Date for Obeticholic Acid as a Treatment for Pre-Cirrhotic Liver Fibrosis Due to NASH
The FDA announced that it will convene a one-day Advisory Committee meeting on May 19 to discuss Intercept Pharmaceuticals’s recently submitted therapy obeticholic acid (OCA) in NASH-related pre-cirrhotic liver fibrosis. The agency previously accepted Intercept’s application with a targeted decision date of June 22. Read more here.
Digital Lifestyle Intervention Tools May Help Patients with NAFLD
According to a new review, digital therapeutics could benefit patients with NAFLD. Digital therapeutics can glean insights into personalized treatment plans through the use of wearable devices, smart apps, and other measurement tools. “We’re seeing a revolution in lifestyle interventions to treat obesity, metabolic syndrome, and NAFLD. It’s important to understand the capabilities of these devices, but I’m optimistic that we’re getting to a point where we may be able to manage patients through a digital platform and virtual visits.” said Dr. Naim Alkhouri, Director of the Fatty Liver Program at Arizona Liver Health, a GLI Liver Action Network member.
