White House Called Upon to Help Provide Greater Access to Hepatitis C Treatment

Advisors from the Public Health Service and President Obama’s Advisory Council on HIV/AIDs told the White House that restrictions placed on drugs for the treatment of hepatitis C conflicted with treatment guidelines provided by healthcare professionals and the Department of Veteran Affairs.

In the letter to President Obama, the advisory council said restrictions are “unreasonable and discriminatory” and “not supported by medical evidence.” It urged the federal government to require states to loosen or eliminate restrictions and provide greater access to treatment.

Each state negotiates the pricing with manufacturers for hepatitis C drugs. The advisory council criticized three restrictions:

  1. States that require patients to be drug or alcohol free for a year prior to treatment.
  2. States that require a healthcare specialist such as infectious disease experts or gastroenterologists to prescribe the treatment.
  3. States that require only patients with advanced liver disease.

The advisors did not say how to pay for the cost of new treatments available but called on Medicaid and other public programs to disclose the prices they pay for the treatments. Additionally, manufacturers should release development and production costs for the drugs.

The Infectious Diseases Society of America and the American Association for the Study of Liver Diseases guidelines states all patients with chronic hepatitis C should be treated unless they only have a year or less to live.

Many experts believe it’s more cost-effective to treat patients early on versus waiting for complications such as advanced liver disease, liver failure, or liver cancer. While, several government officials expressed fear that any directives placed on Medicaid could open the door for similar mandates for other conditions.

Federal officials have called hepatitis C the silent epidemic. In the United States, nearly 20,000 people per a year die from hepatitis C, which is more than AIDs. About one-fourth of patients with HIV are also co-infected with hepatitis C.

Newer treatments include Sovaldi and Harvoni from Gilead Sciences, Viekira Pak and Technivie from AbbVie, Olysio from Janssen, and Daklinza from Bristol-Myers Squibb. Sustained virologic response (SVR) is the marker for a cure of hepatitis C, and many of the newer treatments have a 90% or higher SVR rate. All were approved by the Food and Drug Administration (FDA) within the last few years. For the recommended 12 week treatment duration, Harvoni costs approximately $94,500 and Sovaldi about $84,000.1,2,3

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