New Year, New Strategies for Liver Health

POLICY PERSPECTIVE

New Year, New Strategies for Liver Health

2017 kept many patient advocates on the defensive. We mobilized to push back on multiple attempts to raid public health and prevention funds to pay for CHIP coverage for children in working class families, refusal to cover cost-sharing provisions with payers to benefit the poor, and efforts to destabilize the Affordable Care Act.  An opioid crisis plan was presented with little funding or qualified leadership. A final insult came as the year was ending with the wholesale dismissal of all remaining members of the Presidential Advisory Committee on HIV/AIDS which included viral hepatitis activities. Yet, this is not the time to lose hope.

On the plus side, a robust research and development pipeline of potential treatments for a range of liver diseases makes its way to a well-functioning United States Food and Drug Administration under the new leadership of Dr. Scott Gottlieb. Partnerships with patients and patient advocates are now assumed across most aspects of healthcare agenda-setting and decision-making. 2018 midterm elections provide an opportunity to send representatives who prioritize the health of the nation as essential to making it great.

GLI is prepared to seize the opportunities presented in this new year by training a new class of advocates in GLI’s Advanced Advocacy Academy (A3), starting Phase II of our GLI NASH Council, convening stakeholders across hepatology, endocrinology, and cardiology to address fatty liver disease, and continuing our collaborations with cancer organizations to raise the profile and standard of care in liver cancer, and partnership with our like minded colleagues in Europe and the UK. Our experience demonstrates that strategic, coordinated, united efforts can still prevail to advance the cause of liver health even against the headwinds of this current climate.

Will you stand strong with us and make 2018 a great year for liver patients?

- Donna Cryer, JD, President & CEO, GLI

OPEN ADVOCACY OPPORTUNITIES

  • Are you or do you know a patient advocate interested in becoming a member of the FDA’s Patient Engagement Collaborative (PEC)? Learn more about what it means to become a member of the PEC and apply or nominate someone else.

  • Nominations are now open for the 2018 Rare Impact Awards. If you or someone you know has done outstanding work and had a positive impact on the rare disease community in 2017, nominate them for the 2018 Rare Impact Award.  

  • Participate in the HOPE Study, a hepatitis B and C observational, longitudinal, prospective study. Participants will be seen on an annual basis with optional additional visits for up to 10 years and provide biologic samples for research and evaluation of disease progression.

  • Are you a liver cancer patient or survivor? The Exercise Oncology Lab at the University of Illinois at Urbana-Champaign is conducting an online study examining exercise programming and counseling preferences of liver cancer patients and survivors

POLICY DEVELOPMENTS AT GLI

NASH News

GLI has created a new monthly newsletter, NASH News, to report developments in various organizations as well as policy updates, and upcoming conferences. The purpose of NASH News is to help an expanding set of stakeholders, patients, and others stay up to date on NASH-related activities. Subscribe to NASH News before its second publication, coming soon!

Advanced Advocacy Academy

GLI’s Advanced Advocacy Academy (A3) brought together students and faculty from more than a dozen states to learn what it means to be a liver health advocate. Over the course of two days, patients and caregivers learned about clinical research and development, value frameworks, legislation, healthcare delivery, and more. One patient said, “I appreciated the diversity of topics and the incredibly high caliber of presentations. It definitely exceeded my expectations!” Learn more about A3 and apply for next year’s Academy!

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GLOBAL

European Association for the Study of the Liver (EASL)

EASL released the EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. According to Mayo Clinic, primary biliary cholangitis (PBC) is an autoimmune disease characterized by the slow and progressive destruction of small bile ducts in the liver and subsequent liver inflammation. Read EASL’s PBC clinical practice guidelines, published in the Journal of Hepatology.

The first EASL NAFLD Summit was held on November 9-11, 2017 in Rome, Italy. The 2017 theme was “target-oriented approach or Diagnosis and Pharmacotherapy of Nonalcoholic Steatohepatitis (NASH), a dialogue between Academia and Industry”. Over 400 attendees delved into issues such as the relationship between fatty liver and hepatocellular carcinoma (HCC), lipotoxicity, bile acid signaling, and innovative therapeutic tools. Read the summary of the first EASL NAFLD Summit and get access to the conference debriefing available on YouTube.

HHS NEWS

Food and Drug Administration (FDA)

FDA Commissioner Scott Gottlieb published a blog post at the end of 2017 detailing some of FDA’s policy goals for 2018. Some of these goals include advancing drug safety, empowering consumers, providing better information on drugs, and modernizing standards. According to Commissioner Gottlieb, FDA has identified more than 70 actions that will help FDA to better protect and promote the health of the public. Learn more about FDA’s 2018 policy goals.

After many requests for increased FDA patient engagement initiatives, FDA has established an outside group that will examine and provide input on patient engagement throughout the agency.  The Patient Engagement Collaborative (PEC) will be coordinated by the FDA and the Clinical Trials Transformative Initiative. Its members will represent the patient community as patients with person disease experience, patient caregivers, and representatives from patient advocacy groups. Learn more about the PEC and nominate someone to join on behalf of liver patients.

NGOs

National Organization for Rare Disorders (NORD)

NORD published three new physician guides for rare diseases including one for hepatocellular carcinoma (HCC), a cancer of the liver. According to NORD’s medical writer Marsha Lanes, MS, CGC, “NORD’s information for healthcare providers is intended to facilitate timely diagnosis and optimal care. Our information for patients and caregivers helps them participate as informed and active partners in their care”. Learn more about what NORD is doing in the field of rare liver diseases and the unique experiences patients with rare diseases face.

GRANT OPPORTUNITIES

Mechanisms of Disparities in Chronic Liver Diseases and Cancer. Funds available from NIH: $200,000. Application deadlines: April 4, 2018 or April 4, 2019.

HIV/HCV Co-Infections in Substance Abusers (R01). Funds available from NIH: $3,000,000. Application deadline: January 8, 2018.

HIV and Hepatitis B Co-Infection: Advancing HBV Functional Cure through Clinical Research (R21). Funds available from NIH: $275,000. Application deadline: May 8, 2020.

Addressing Health Disparities in NIDDK Diseases (R01 Clinical Trial Not Allowed). Funds available from NIH: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications; application budgets are not limited but need to reflect the actual needs of the proposed project. Application deadline: January 7, 2020.

Eugene Washington PCORI Engagement Awards. Funds available from PCORI: $250,000. Application deadline: letter of intent (LOI) due February 1, 2018 with full proposals due 40 days after approval of LOI.

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NAMES TO KNOW

Senate Majority Leader Mitch McConnell (R-Ky.)

Senator Bill Cassidy (R-La.)

Senator Lindsey Graham (R-Sc.)

Eric D. Hargan. Secretary of the United States Department of Health and Human Services.

Senator Doug Jones (D-Al.)

Ronald J. Sokol, MD, FAASLD. American Association for the Study of Liver Diseases (AASLD) President.

Policy UpdatesDonna Cryer