National study finds life-threatening barriers in access to breakthrough drugs
The Miriam Hospital physician leads first systematic study of Medicaid policies for hepatitis C treatment
29-Jun-2015 - PROVIDENCE, R.I. - Most states violate federal Medicaid law because they deny coverage
for sofosbuvir, a new and highly effective treatment to cure hepatitis C, according to Lynn E. Taylor,
M.D., director of The Miriam Hospital's HIV/Viral Hepatitis Coinfection Program. Taylor's team of
researchers examined Medicaid policies for hepatitis C virus treatment using sofosbuvir, more
commonly known as Solvadi, and found that most should change policy to improve access to the
treatment. The study and its findings were published online in advance of the August issue
of the Annals of Internal Medicine.
Hepatitis C virus affects over three million Americans. Worldwide, an estimated 120 to 150 million
people have chronic hepatitis C. Left untreated, the infection can lead to cirrhosis, liver failure,
and liver cancer. Sofosbuvir is a highly effective pharmaceutical used in combination with other
medications to cure the disease.
Taylor's research team, which included the Harvard Law School Center for Health Law and Policy
Innovation, Treatment Action Group, Kirby Institute of Australia, and Brown University, found
that most Medicaid coverage restrictions for sofosbuvir violate federal Medicaid law, which
requires states to cover drugs consistent with their U.S. Food and Drug Administration (FDA) labels.
"Federal Medicaid law requires coverage, yet reimbursement criteria for Medicaid programs effectively
deny access," said Taylor, lead author of the study. "The denial of treatment by most states violates
the spirit of the law. In our analysis, we found that most states with known sofosbuvir Medicaid
reimbursement requirements impose undue restrictions on eligible recipients."
The most common restrictions fall into three categories: 1) The level of fibrosis (i.e., scarring of
the liver); 2) substance use and abstinence from alcohol/drug use together with toxicology screening;
and 3) provider limitations, which limit the physicians allowed to prescribe sofosbuvir.
"Ultimately, we found that access restrictions are not based on scientific evidence, current treatment
guidelines, or clinical data," said co-author Robert Greenwald, J.D., director of Harvard Law School's
Center for Health Law and Policy Innovation. "Notably, 74 percent of the 42 state Medicaid programs
for which information is available limit treatment to individuals with advanced fibrosis or
cirrhosis. Such restrictions contradict the American Association for the Study of Liver
Disease and the Infectious Disease Society of America treatment guidelines which
support treatment for all hepatitis C-infected persons, except those with
limited life expectancy (less than 12 months) due to non-liver-related diseases."
"Rates of advanced liver disease complications and associated healthcare costs are rising in the U.S.,"
added Taylor. "Although there is a high risk of progression to decompensated cirrhosis and liver cancer
among patients with advanced fibrosis, limiting access to people who have already progressed to
late-stage disease as compared to treating earlier to prevent these liver-related
complications seems counter-intuitive as a public health strategy."
Restrictions based on drug and/or alcohol use were also common. Among the state Medicaid programs for
which information was available, 88 percent of states include drug and/or alcohol use or abuse in
their eligibility criteria, with 50 percent requiring a period of abstinence of three to 12
months and 64 percent requiring negative urine drug screening.
"This is particularly concerning because the majority of new and existing cases of hepatitis C in
the U.S. exist among people who inject, or have injected drugs," said Taylor. "Rather than excluding
people who use alcohol or drugs from hepatitis C treatment, even those with cirrhosis, they
should be a priority group due to both improved individual health outcomes and potential
hepatitis cure as prevention benefit."
Since 2002, the National Institutes of Health hepatitis C guidelines have supported hepatitis C
treatment regardless of injection drug use. International guidelines from the American
Association for the Study of Liver Disease/Infectious Diseases Society of America,
the European Study for the Association of the Liver, the International Network
for Hepatitis in Substance Users, and the World Health Organization, now all
recommend treatment for hepatitis C infection among people who use drugs.
"There is compelling evidence that hepatitis C treatment is safe and
effective among people who inject drugs," said Taylor.
Taylor's team searched state Medicaid websites from June 23 to December 7, 2014. Data extracted
included whether sofosbuvir was covered and coverage criteria based on liver disease stage; HIV
coinfection; prescriber type; and drug/alcohol use. One quarter of states require HIV/HCV
coinfected persons to be receiving antiretroviral therapy or have suppressed HIV RNA
levels (no detectable HIV virus in the blood). Two thirds of states have
restrictions based on prescriber type.
"The Medicaid restrictions generally apply to the poorest and most underserved patients with hepatitis C
infection, are highly stigmatizing, and not based on evidence," said co-author and associate professor
Jason Grebely, Ph.D., of the Kirby Institute at UNSW Australia. "The data suggests that state
Medicaid policies for access to new hepatitis C therapies should be reviewed and revised
in line with national and international clinical recommendations."
Tracy Swan, co-author and hepatitis/HIV project director at Treatment Action Group, said, "It is
unacceptable for treatment to be held hostage by state Medicaid programs. Medicaid programs have
never forced people to wait for treatment until they are so sick that they are left with a
higher liver cancer risk even if they are cured. We would never refuse treatment for
cancer or other infectious diseases¬, nor do we withhold treatment for these
illnesses from people who drink alcohol or use drugs."
"In distinct contrast to the situation in the U.S., Australia's Pharmaceutical Benefits Advisory
Committee (PBAC) recently recommended two highly effective sofosbuvir-based regimens for
Pharmaceutical Benefits Scheme (PBS) listing, without drug use or disease stage-related
restrictions," said co-author and professor Greg Dore of the Kirby Institute. "Assuming
that price negotiations are completed and Federal Cabinet approval gained, Australia
should have the broadest access to interferon-free therapy internationally, with
PBS listing expected in December 2015 or April 2016."
"Access to treatment should be based on clinical criteria and medical evidence," Taylor concluded.
"The current restrictions do not make clinical, public health, or long-term economic sense, and
should be removed. It is critically important that patients have access to highly effective
drugs that not only cure them but will also lower the associated costs of long-term
management of the disease. Based on the study findings, states need to review and
revise their access criteria to align with clinical recommendations."
Taylor, also an assistant professor of Medicine in the Division of Infectious Disease at the Warren
Alpert Medical School of Brown University, is a viral hepatitis and HIV/AIDS expert and primary care
physician. She focuses on prevention and treatment of HCV and HIV in vulnerable populations and
on the primary care of people living with HIV. In 2013, Taylor was awarded a Rhode Island
Innovation Fellowship entitled, "Rhode Island Defeats Hep C," a project dedicated to
the elimination of HCV in Rhode Island. She is organizing the Second C is for Cure:
A Waterfire Lighting for RI Defeats Hep C, Providence, R.I., to be held on August 1.
Soumitri Barua of Brown University '17, MD'21, was also a key researcher on this study.
About The Miriam Hospital
The Miriam Hospital is a 247-bed,
not-for-profit teaching hospital affiliated with The Warren Alpert Medical School of Brown
University. It offers expertise in cardiology, oncology, orthopedics, men's health, and
minimally invasive surgery and is home to the state's first Joint Commission-certified
Stroke Center and robotic surgery program. The hospital, which received more than
$23 million in external research funding last year, is nationally known for its
HIV/AIDS and behavioral and preventive medicine research, including weight
control, physical activity and smoking cessation. The Miriam Hospital
has been awarded Magnet Recognition for Excellence in Nursing
Services five times and is a founding member of the
Lifespan health system. Follow us
on Facebook, Twitter ( @MiriamHospital ) and Pinterest.
About The Center for Health Law and Policy Innovation of Harvard Law School
The Center for Health Law and Policy Innovation of Harvard Law School (CHLPI) advocates for legal,
regulatory, and policy reforms to improve the health of underserved populations. CHLPI works with
consumers, advocates, community-based organizations, health and social services professionals,
government officials, and others to expand access to high-quality healthcare; to reduce
health disparities; to develop community advocacy capacity; and to promote more
equitable and effective healthcare systems. CHLPI is a clinical teaching
program of Harvard Law School and mentors students to become skilled,
innovative, and thoughtful practitioners as well as leaders in
health and public health law and policy. To learn more, visit http://www.chlpi.org.
About The Kirby Institute at UNSW Australia
The Kirby Institute at UNSW Australia is a world leader in research dedicated to the prevention and
treatmetn of HIV, viral hepatitis and sexually transmissible infections. Its research draws from
many disciplines to develop outcomes that bolster prevention efforts, provide improved
treatments and build regional capacity against infections that occur in every
community. To learn more, visit http://www.kirby.unsw.edu.au.
About Treatment Action Group
Treatment Action Group (TAG) is an independent AIDS research and policy think tank fighting for
better treatment, a vaccine, and a cure for AIDS. We are science-based treatment activists
working to expand and accelerate vital research and effective community engagement with
research and policy institutions. To learn more about TAG, visit http://www. treatmentactiongroup. org.
TAG's Hepatitis/HIV Project follows and reports on HCV drug development. To learn more,
visit http://www.pipelinereport.org. The
Hepatitis/HIV Project draws from the core values and history of HIV activism, while incorporating
hepatitis C-specific information into strategies targeting different constituencies, regions,
and countries. TAG's Hepatitis/HCV project works to optimize quality of, and broaden access
to HCV care and treatment through our work with people living with, or at risk for HIV
and hepatitis C and their communities, activists, researchers, regulatory agencies,
clinicians and pharmaceutical companies.
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