WASHINGTON, D.C. ( June 4, 2015 ) — With mounting evidence that many public and private health plans are deliberately rationing care for Americans with the hepatitis C virus ( HCV ), those on the front lines in fighting viral hepatitis and HIV/AIDS today urged lawmakers to overturn state Medicaid and managed care policies that discourage testing, add prior authorization requirements on clinicians, and create significant hurdles for patients to receive new curative treatments — all contributing to only 5% to 6% of individuals with HCV being successfully treated.
Assembling in Washington for the 2015 National Summit on HCV and HIV Diagnosis, Prevention and Access to Care,HCV and HIV specialists called on policymakers to pass state laws mandating that insurance plans follow evidence-based medical guidelines when covering HCV testing and treatment. These guidelines — published jointly by the American Association for the Study of Liver Diseases ( AASLD ) and the Infectious Diseases Society of America ( IDSA ) and also by the Department of Veterans Affairs — support treatment in all HCV-infected people except those with a life expectancy of less than a year due to non-liver medical conditions. Moreover, the advocates urged states to enact laws requiring Medicaid programs to offer first-line HIV medications and new HCV drugs on their formularies and to cap the co-payments for these therapies, ending system-wide practices by both public and private insurers that restrict access to these drugs.
These actions are necessary now that a just-issued review of ten state Medicaid programs from the Center for Health Law and Policy Innovation of Harvard Law School documents system-wide insurance restrictions that keep the majority of HCV-infected individuals from being treated with new and more expensive oral HCV drugs. While the practices vary from state to state, and even among different plans in the state, they are designed to be exclusionary by only allowing patients with advanced liver disease to receive the new drugs, authorizing only a small number of medical specialists to prescribe the drugs, excluding alcohol- and substance-using individuals, and restricting access based on HIV co-infection. These exclusionary practices also apply to a number of private health plans, resulting in a series of lawsuits in California.
"These developments represent a wake-up call for the viral hepatitis community and should spark a national movement to ensure all Americans diagnosed with HCV are treated for their infection — curing them of HCV— which will profoundly reduce the spread of the virus," said Veronica Miller, PhD, Executive Director of the Forum for Collaborative HIV Research, which convened the summit. "While the cost of new therapies is a legitimate topic, without testing and treatment there will be little hope of reducing the burden of HCV and bending the cost curve."
Action Needed As HCV Rates Rise Dramatically
Mobilizing the public health community around expanded access to HCV testing and treatment is especially warranted now that the Centers for Disease Control and Prevention ( CDC ) is grappling with twin epidemics in the U.S. — one affecting an estimated 2.7 million Americans, mostly baby boomers ( born from 1945-1965 ) who are living with chronic HCV, and a separate explosion of acute HCV primarily occurring east of the Mississippi River in young adults who inject drugs.
In the case of chronic HCV, disturbing new data reveal that among the baby boomers tested between 2010 and 2013 and found to have HCV, half of those infected already had severe liver damage at diagnosis. Also of concern, just- released findings from a large study of HCV patients who were prescribed the new HCV drug sofosbuvir cited insurance barriers and cost concerns as the reason 81% of the patients did not start the therapy. Taken together, these findings underscore the need for coverage policies that increase screening efforts and ensure that infected Americans are treated effectively to prevent cirrhosis and hepatocellular carcinoma ( HCC ), the most common type of liver cancer. Estimates for treating advanced liver disease in the HCV population run as high as $9 billion annually.
With acute HCV, the challenge is responding to a very different epidemic fueled by prescription-drug abuse among those who inject drugs. According to John Ward, MD, Director of CDC's Division of Viral Hepatitis, CDC has been concerned for several years about the rising number of new cases of acute hepatitis C virus from an increasing number of states. The CDC has tracked the spread of acute HCV infections across the nation since it was first reported in 2009 in Massachusetts, with the largest increases among people under age 30 living in Kentucky, Tennessee, Virginia, and West Virginia. According to new CDC data, infections rose 364% from 2006 to 2012 in these four states alone.
"It is a sad fact that both public and private insurers are responding to these twin epidemics by restricting access to new HCV drugs that have been found to produce high cure rates, sometimes exceeding 90%, within 12 weeks of treatment," said infectious disease expert John G. Bartlett, MD, Professor Emeritus of Medicine in the Division of Infectious Diseases at The Johns Hopkins University School of Medicine. "We urgently need coverage policies that are intended to stem the tide of HCV and reduce its societal burden."
Coming to Grips With the Unequal Burden of HIV
While reducing the access barriers to effective HCV detection and treatment is a priority concern, the Summit will also focus on the challenges of testing and getting timely treatment for those most affected by HIV — especially now that new data from the NIH-sponsored study Strategic Timing of Antiretroviral Treatment ( START ) confirms the substantial advantages of universal testing, linkage to care and immediate/early HIV treatment — starting right after diagnosis — both to improve medical outcomes and to prevent the spread of HIV.
Describing HIV/AIDS as a disease of racial and ethnic health inequalities exacerbated by discrimination, poverty and homophobia, Kenneth H. Mayer, MD, Director of HIV Prevention at Beth Israel Deaconess Hospital and the Medical Research Director of The Fenway Institute in Boston, said the epidemic has changed. Today, HIV disproportionately affects men who have sex with men ( MSM ), minorities, transgender people, and the poor and is concentrated in poor and disenfranchised areas of large cities with populations of more than 500,000 people. The cities hardest hit by HIV areAtlanta, Ga.; Miami, Fla.; Washington, D.C.; Baton Rouge and New Orleans, La.; Memphis, Tenn.; and Baltimore, M.D.
Among the populations hardest hit are African Americans, who now account for almost half of new infections ( 44% ) and represent 41% of those living with HIV. Latinos are also disproportionately affected, accounting for 21% of all new HIV infections and 20% of people living with HIV. At the same time, infection rates are rising among MSM of all races but especially in young black MSM ( aged 13-24 ) who now account for more new infections than any other subgroup by race/ethnicity, age, and sex. In 2010, young black MSM accounted for 45% of new HIV infections among other black MSM and 55% of new HIV infections among young MSM overall. In addition, two highly stigmatized populations — transgender women and injection drug users — are at high risk for HIV. According to CDC data, 28% of transgender women tested HIV positive in 2008, whereas injection drug users now represent 8% of new HIV infections each year and 16% of the U.S. population living with HIV.
Confronted with these changing demographics, the public health community is stepping up efforts to diagnose HIV infection early and then link infected individuals to care — meaning these people enter the health system in a timely fashion and then are retained in care so they receive medical treatment and are prescribed antiretroviral therapy ( ART ). In some aspects, these efforts have been successful: today, 86% of infected individuals know their status and 80% were initially linked to care.
However, 60% of Americans with HIV are not receiving regular HIV care, according to the latest CDC data. As a result, only three in ten people living with HIV had their virus under control in 2011 — translating into 840,000 people living with actively replicating HIV. Further defining the problem, 2014 data reveal that 20% of people whose virus is not under control still don't know they are infected and 66% are not engaged in regular HIV care.
"What we are finding is that even when disenfranchised and socially marginalized individuals are diagnosed with HIV, they fall through the cracks in the healthcare system," said Dr. Mayer. "If we are to reverse the tide of the HIV epidemic, we must focus on the root causes of HIV disparities in at-risk communities, including stigma, poverty, STI prevalence, incarceration, and limited social mobility."
About the 2015 National Summit on HCV and HIV Diagnosis, Prevention and Access to Care
The 2015 National Summit on HCV and HIV Diagnosis, Prevention and Access to Care ( June 4-6, 2015 at the Hyatt Regency Crystal City Hotel in Arlington, Va. ) will bring together an estimated 300 scientists, clinicians, public health leaders and advocates to address the persistent barriers that keep too many Americans from getting tested for HIV and HCV, linked to care and able to benefit from the newest therapies, despite the intent of the Affordable Care Act. The National Summit is hosted by the Washington, D.C.-based Forum for Collaborative HIV Research and is an IAS 2015 Independent Affiliated Event.
About the Forum for Collaborative HIV Research
Founded in 1997 and now part of the University of California ( UC ), Berkeley School of Public Health, the Forum is a public/private partnership representing government, industry, patient advocates, healthcare providers, foundations and academia working to advance scientific advances in five disease areas: HIV, HCV, hepatitis B virus ( HBV ), Cytomegalovirus ( CMV ) and transplantation, and liver diseases. In addition to hosting the National Summit, the Forumorganizes roundtables and issues reports on a range of issues, including treatment-related toxicities, immune-based therapies, health services research, co-infections, prevention, and the transference of research results into care. More information is available at: www.hivforum.org .