Looking Ahead for Liver Health
Looking Ahead for Liver Health
All policy is liver health policy. In the two years since we launched the GLI Liver Health Policy Update one of our top priorities has been to expand the number of issues that are recognized as impacting liver patients and would benefit from the voices of liver health advocates. Liver patients, and those at risk of developing a liver disease, are in every community across the globe and are affected by a wide array of regulatory issues that determine how quickly new treatments can come to market. Regulations concerning pricing, reimbursement, and utilization management issues which either facilitate or limit access to treatments, the structure of healthcare delivery models for the specialized care that liver patients need and deserve, and funding for research so that more children, teenagers, working age adults, and seniors living with liver disease can be cured - you will see all those issues, as they arise in the U.S. and abroad, featured here.
Please let us know if and how the GLI Liver Health Policy Update has helped your advocacy or send us policy items via email at email@example.com to be featured. Happy Holidays!
Donna R. Cryer, JD
President & CEO
Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
CMS has initiated a comment period until December 31st 2018, for rules regarding payments for home based care. The rule certifies payment systems for Medicare home health episodes and guarantees periods of 30 days are covered and without threshold for coverable home based therapies. These services include infusion therapies, where drugs for chronic or acute conditions, such as cancer or gastrointestinal diseases, are administered intravenously by a licensed care provider at the patient’s home. It further expands the accreditation process for home infusion therapy professionals and allows easier payment reimbursement for these therapies. Comments may be submitted either electronically or by mail.
FDA is seeking industry comments on new draft guidance for development of new therapies for chronic hepatitis B virus (HBV). The guidance aims to assist pharmaceutical sponsors in the initial application stages, development of new drugs, and postmarketing phases for HBV treatments. The agency is seeking both written and electronic comments for the guidance document to be submitted before January 1st 2019 when it will be finalized.
POLICY DEVELOPMENTS AT GLI
GLI has joined with Part B Access for Seniors and Physicians (ASP) Coalition and several organizations in a sign on letter against implementation of an International Pricing Index model for Medicare Part B drugs. In order to continue protecting the Part B program and patient access to Part B medicines, we invite you to join us in signing on to the letter.
FOR YOUR CALENDAR
January 17-19: Gastrointestinal Cancers Symposium
April 10-14: The International Liver Congress
May 18-21: 50th Anniversary of Digestive Disease Week
September 26-28: EASL NAFLD Summit 2019
Over 12,000 residents have lost Medicaid coverage as of November 15th due to recently instituted work requirements in Arkansas. This marks the third consecutive month that thousands of beneficiaries have been dropped from the state Medicaid program since the rules were instituted in June 2018. Once individuals are dropped, they must wait until the next enrollment period before they can be re-apply, resulting in extensive healthcare coverage gaps for thousands of Arkansas citizens. Arkansas is the first state approved for a Section 1115 waiver that has implemented work requirements for Medicaid coverage.The rapid loss in coverage reveals several flaws in implementing Medicaid work requirements, and groups have argued in a letter to Secretary Azar that further disenrollment should be paused until the program is restructured to enable beneficiaries to better succeed in navigating these work requirement guidelines.
Voters approved Idaho Proposition 2 which will require the state to submit a plan to the Centers for Medicare and Medicaid Services (CMS) to expand Medicaid within 90 days of passing the proposition. The expansion makes adults between 19-65 years of age, whose income falls at or below 133% of the federal poverty line, eligible for Medicaid services. Idaho Governor Brad Little has assured voters he will implement the initiative.
Nebraska residents voted in favor of Nebraska Initiative 427 which will amend the state Medicaid program to include adults whose income falls at or under 138% of the federal poverty limit. The amendment must be submitted before April 1st, 2019 and stipulates that the state government “take all actions necessary to maximize federal financial participation in funding medical assistance pursuant to this section.”
The New York Senate passed bill SO2496 which expands protections for living organ or tissue donors. The act prohibits insurance companies from cancelling or raising premiums for living donors and ensures that corporations provide medical leave for preparation of transplants and recovery from surgery. In addition, the bill calls on the commissioner of health to create and distribute information materials regarding the benefits and impact of becoming a living donor.
The House of Representatives passed bill HB1884, Patient Test Result Information Act, which mandates that all diagnostic test results be sent directly to a patient or a patient designee. The act serves to provide patients with automatic access to their health information within 20 days of testing without having to contact their testing facility or physician to obtain a copy.
Utah passed Utah Proposition 3 which will enact Medicaid expansion for April 2019. The proposal outlines a 0.15% sales tax increase which will help fund Medicaid expansion and help preserve and enhance the state’s Children’s Health Insurance Program (CHIP).
World Health Organization (WHO)
WHO and the European Union (EU) have pledged a renewed commitment to accelerating health outcomes and spreading “right to health” across Europe. A signed joint statement between the EU and WHO promises to set priority goals including efforts to combat noncommunicable diseases, increase access to vaccinations, and strengthen existing health systems.
British Liver Trust
Judi Rhys, Chief Executive of British Liver Trust, has called for increased awareness of liver cancer and demonstrated the rising threat it poses to patients in the UK. Liver cancer rates have tripled in the UK in the last 40 years and experts project that liver cancer cases will double by 2035. Liver cancer has an especially low five year survival rate of 12%, with more than 5,400 UK liver cancer patient deaths each year. To help raise survival rates, British Liver Trust recommends that National Health Services (NHS) and general practitioners promote screening processes and improve training for treatments of liver cancer.
British Liver Trust issued a press release detailing National Institute for Health and Care’s (NICE) approval of the cancer drug, Lenvima® (lenvatinib), as a new first line therapy for hepatocellular carcinoma (HCC) in England and Wales. This marks the first new first line therapy to be approved in over a decade for UK patients. HCC makes up 90% of all liver cancer cases in the UK, yet treatment options remain limited. Over 4,000 HCC patients are now eligible for this new therapy.
Food and Drug Administration (FDA)
FDA proposed a series of expansions to its Drug Competition Action Plan. The plan, created in 2017, seeks to remove obstacles for generic drug development, to increase drug market competition, and to limit pharmaceutical companies from prolonging drug exclusivity periods. A new initiative proposed is the establishment of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH aims to create a single global generic drug development program that can harmonize drug development across multiple markets and facilitate global approval of high quality generic drugs.
Seeking an indication for liver cancer, Keytruda (pembrolizumab) has been granted FDA accelerated approval for patients with hepatocellular carcinoma (HCC) following treatment with Nexavar® (sorafenib). The approval follows a multicenter clinical trial with 104 HCC patients where 89% of recipients showed responses to treatment over 6 months.
FDA Commissioner Scott Gottlieb, M.D., launched new efforts to strengthen FDA’s expanded access program (EA). EA also called “compassionate care,” allows experimental drugs and therapies to be used by patients outside of clinical trials who have no other treatment options. An independent internal review and survey of the program has shown that both patients and physicians are in favor of EA, but find that gaining access to these emergency experimental treatments is often difficult and time intensive. To help improve the program, FDA has streamlined online content and submission policies, created new administrative positions exclusively to oversee EA, and formed the Expanding Access Coordinating Committee. These efforts seek to facilitate terminal patient access to potentially life saving medical therapies.
U.S. Department of Health and Human Services (HHS)
HHS has released an updated second edition of its Physical Activity Guidelines for Americans. These guidelines include the immediate health benefits of daily exercise, including reduction in blood pressure, improved sleep, and increased insulin sensitivity. It also highlights the long term benefits exercise has in preventing several cancer types, increasing brain health, reducing weight gain, and managing chronic physical and mental conditions such as diabetes, depression, anxiety, and dementia related diseases like multiple sclerosis and Parkinson’s disease. While HHS has expanded the list of diseases that exercise has a direct effect on, it fails to mention any correlation between physical exercise and improved liver health. Studies have demonstrated that both liver cancer and fatty liver disease (NAFLD/NASH) patients show improved outcomes through regular exercise which may help prevent hepatocellular damage through reducing fat accumulation in the liver.
National Cancer Institute (NCI)
In a new nationwide NCI study, researchers have discovered high levels of disparity in cancer outcomes between household income levels. While the cancer mortality rate has declined in the US, some lower income counties in the US report seven times as many deaths due to cancer compared to high income areas. Researchers identified eight factors linked to the disparity in low income households and counties’ cancer mortality rates. The investigation found that the strongest factors which accounted for 80% of income level health differences included food insecurity, quality of available and affordable medical care, smoking, obesity, and physical inactivity. Investigators conclude that rural areas with low income must be given greater attention to help overcome these disparities.
US Department of Veterans Affairs (VA)
VA has taken a series of steps to modernize and create an efficient system for meeting veteran healthcare needs. Following an executive order, VA services will be reorganized and consolidated into four distinct offices to help create a more harmonious and transparent system of care.
Centers for Medicare and Medicaid Services (CMS)
November 1st began the start of the sixth Open Enrollment Period for Affordable Care Act (ACA) plan selections. This is the first enrollment period since the removal of the individual mandate from the ACA law, prompting questions as to whether enrollment numbers will decrease as there is no longer a penalty for uninsured individuals. Eligible individuals will be able to search, compare, and select healthcare plans through the federal Healthcare.gov website or through state approved marketplace brokers until December 15th.
Patient-Centered Outcomes Research Institute (PCORI)
PCORI has announced a new strategy for its collaborative data sharing resource, National Patient-Centered Clinical Research Network (PCORnet). Combining Patient Powered Research Networks (PPRNs), Electronic Health Records (EHRs), and Clinical Data Research Networks (CDRNs). PCORnet acts as an innovative research arm that centralizes health data and advances efficient clinical trials that focuses on patient needs foremost. PCORI plans to step away as the sole funding entity for PCORnet and to help with the creation of a self sustaining platform for research and a patient resource. To assist with this transition, PCORI intends to fund PPRNs until March 2019 and create a competitive funding program with awards up to $4 million over the course of 2 years.
National Organization for Rare Disorders (NORD)
NORD has expanded its resources for patients of rare diseases and caregivers by creating a Patient and Caregiver Resource Center. The Resource Center, consolidates all of NORD’s educational content, provides webinars, videos, and disease fact sheets, as well as links to other patient resources.
Mechanisms of Disparities in Chronic Liver Diseases and Cancer (R21). Funding available from NIH. Application deadlines: April 4th, 2019.
Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility. Funding available from NIH Application Deadlines: May 7th, 2021.
NAMES TO KNOW
Tedros Adhanom Ghebreyesus: Msc, PhD, and Current Director-General of the World Health Organization (WHO)
William Asa Hutchinson II: Republican governor of Arkansas since 2015.
Judi Rhys: Chief Executive of the British Liver Trust.
Francis J. Rienzo: Interim CEO, Medicaid Health Plans of America.
TERMS TO KNOW
Sorafenib: generic name of Nexavar®, a protein tyrosine kinase inhibitor (TKI) medication which stops cancer cell growth by blocking growth signals and preventing blood vessel formation in cancerous tumors.
A new study has discovered that mothers who breastfeed their children for six months or more lower the mother’s risk for developing fatty liver disease later during middle age.
Researchers have identified the mechanism of actions by which inflammatory cytokines produce fibrosis, hepatic scarring, through immune cells.
The next issue of Liver Health Policy Update will be published on February 1, 2019.