Community Leaders, HIV Doctors Oppose Hepatitis C Treatment Barriers

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A coalition of hepatitis C advocacy organizations and medical providers has issued an open letter to the Secretary of Health and Human Services calling for an end to restrictions on access to hepatitis C treatment by private insurers and public payers seeking to avoid the cost of newly approved direct-acting antivirals. HIV medical providers also called for reducing barriers to treatment, including restrictions on which medical specialists may treat people with hepatitis C.

Over years or decades chronic hepatitis C virus (HCV) infection can lead to serious liver disease including cirrhosis and liver cancer. When interferon-based therapy was the standard of care -- which took 6 to 12 months, caused difficult side effects, and only cured half of treated patients -- many experts advised treatment only for people with advanced liver disease.

But in the era of highly effective and well-tolerated new therapies, a growing number of advocates and providers are proposing that treatment should be available to all who want it. The new drugs are expensive, however, and many people with hepatitis C rely on public funding through Medicaid, Medicare, and state prison budgets.

A coalition of leading hepatitis C advocacy organizations and medical experts have called on Health and Human Services Secretary Sylvia Mathews Burwell to take leadership in eliminating discriminatory barriers to hepatitis C treatment access, according to a press release issued by the National Viral Hepatitis Roundtable (NVHR), Project Inform, and other concerned groups. The coalition sent a letter expressing alarm over restrictions placed by many public and private payers on access to the new treatments. The coalition also sent a statement signed by over 700 organizations, individuals, and medical providers demanding availability of treatment for everyone living with hepatitis C and "calling on all stakeholders, including government, the pharmaceutical industry, and public and private payers to work together on solutions."

"The recent FDA approval of highly effective new treatments brought tremendous hope to the millions of Americans estimated to have chronic hepatitis C," said NVHR executive director Ryan Clary. "However, that hope quickly diminished when public and private payers, including many state Medicaid programs, implemented restrictions that provide access only to the sickest patients and deny access to those with active or recent substance use issues. These barriers undermine the purpose of the Affordable Care Act both to provide quality affordable health care to people regardless of pre-existing conditions and also to eliminate health disparities."
 
Advocates are particularly alarmed by restrictions imposed by state Medicaid programs, the safety net health program for low-income Americans. A preliminary analysis suggests that many states are limiting treatment to people with severe liver damage -- advanced fibrosis (Metavir stage F3) or cirrhosis (F4) -- and are requiring that prospective patients have pre-treatment periods of sobriety usually between 3 and 6 months.
 
According to the release, these restrictions contradict recommendations in a recent article published in Antiretroviral Research by Brian Edlin and Emily Winkelstein of Weill Cornell Medical College and the National Development and Research Institutes, in which they make the case for hepatitis C eradication in the U.S. -- an achievable goal, but one facing serious challenges. Widespread treatment not only could cure most people currently living with hepatitis C, but could also dramatically reduce HCV transmission.

"At this watershed moment in the epidemic, just at the moment that we have the tools to eradicate this scourge, it would be a perverse and shameful indictment of our healthcare system if the structure of medication financing in our country were to foil our ability to use them," said Edlin, a co-signer of the letter. "Affordable pricing will assure the largest possible market for the drugs, a win-win arrangement. Government, industry, and payers must work together to reach agreements to assure full access to antiviral drugs for all who need them."

"Everyone living with hepatitis C deserves lifesaving treatment," added Emalie Huriaux of Project Inform. "Treatment decisions should be made by people with hepatitis C and their doctors, not by insurance companies."
 
In a related move, the American Academy of HIV Medicine (AAHIVM), the HIV Medicine Association (HIVMA), and the Infectious Diseases Society of America (IDSA) have challenged health plan cost-control efforts that bar many qualified HIV care providers from offering hepatitis C treatment by limiting such care to providers trained as gastroenterologists, hepatologists, or infectious diseases specialists.

Approximately 25%-30% of the more than 1 million Americans living with HIV are coinfected with HCV, and many receive most of their medical care from HIV specialists. HIV providers are well versed in managing antiviral therapy, monitoring viral load, dealing with side effects, drug interactions, and adherence, and other issues likely to arise in hepatitis C treatment.

"There is no medical rationale for excluding some HIV providers from prescribing HCV medications," said HIV specialist Donna Sweet, chair of the AAHIVM board of directors. "HIV providers who have been treating HCV/HIV coinfected patients for years are uniquely qualified to manage potential drug toxicities and side effects stemming from combining treatment for HIV and HCV. These restrictive policies not only limit access to the new HCV treatment for many people with HIV but could lead to treatment disruptions and other serious adverse health consequences for patients."

"Thanks to the treatments available today, most of our patients with HIV do not die from AIDS-related illness, but from other conditions, including liver disease," said HIVMA chair and HIV specialist Joel Gallant. "Many people coinfected with HIV and HCV have been waiting a long time for more effective and tolerable HCV treatment. Now that a cure is available, it is unconscionable to deny them access to medical providers who are well qualified to administer and manage this treatment."

"It is estimated that half of patients infected with hepatitis C are unaware of their status," said IDSA president Barbara Murray. "As increased emphasis on testing and diagnosis is realized, we may be faced with a shortage of physicians available to treat and care for these patients. Now is not the time to place restrictions on the availability of physicians, especially those with some of the most experience treating this disease."

9/12/14

Sources

National Viral Hepatitis Roundtable, Project Inform, et al. Community Leaders Call For End To Hepatitis C Treatment Access Crisis. Press release. September 10, 2014.

American Academy of HIV Medicine and HIV Medicine Association. HIV Medical Organizations Challenge Insurer Restrictions to HCV Treatment. Press release. September 3, 2014.

Infectious Diseases Society of America and HIV Medicine Association. IDSA, HIVMA Call for State Medicaid Programs to Lift Hepatitis C Prescribing Restrictions from ID and HIV Doctors. Press release. September 9, 2014.