Hepatitis C Treatment to be Afforded to All Infected Veterans, Regardless of Stage of Disease

An increase in funding from Congress and a decrease in drug prices will allow the Department of Veterans Affairs (VA) to finance medical care for all hepatitis C (HCV) patients, regardless of the stage of the disease, for the fiscal year 2016.

HCV Treatment for Veterans: Past Programs

Previously, under the Choice Program, treatment priority was given to the most ill of patients. Veterans were also excluded from antiviral HCV therapy if they met the following criteria:

• Had advanced comorbidities, including severe end-stage congestive heart failure, widely metastatic carcinoma, or hepatocellular carcinoma, with a life expectancy of 12 months or less
• Had confirmed irreversible cognitive impairment, including persistent vegetative state or advanced dementia
• Were infected with antiviral-resistant HCV strains
• Had a Model for End-Stage Liver Disease (MELD) score >30

The aforementioned veterans who were excluded from antiviral HCV treatment were provided with all other medical care needs associated to this illness. If a patient or his or her healthcare provider felt that the decision to deny treatment failed to abide by the established prioritization protocol, an appeal could be filed. An appeal to exempt a veteran from the protocol needed approval from the Office of Public Health and the National Center for Ethics in Health Care.

In the past, the VA treated more than 76,000 veterans infected with HCV, of which 60,000 are now HCV-free. Since the beginning of 2014, 42,000 vets were provided with the most recent, highly effective antiviral treatments.

Moving Forward With HCV Treatments

For fiscal year 2015, $696 million, or 17% of the VA’s total pharmaceutical budget, were allocated for new HCV drugs. This fiscal year 2016, the VA plans on spending $1 billion on HCV drugs alone, which will allow the initiation of weekly HCV treatment to a total of 200,000 currently infected veterans, of which only 174,000 are currently registered in a VA health plan.

According to a statement released on March 9, 2016, Secretary for Health, David Shulkin, MD, said on behalf of the VA, “If veterans are currently waiting on an appointment for community care through the Choice Program, they can now turn to their local VA facility for this treatment or can elect to continue to receive treatment through Choice Program.”

According to Military Times, Gilead Sciences, the manufacturer of sofosbuvir as well as the brand name drugs Sovaldi and Harvoni (which are manufactured for $1,400) has been criticized by lawmakers for charging the federal US government $68,000 for treatment regimens, forcing public health officials, including the VA, to only treat the most severe cases. In January 2016, Zepatier, a new HCV antiviral drug produced by Merck, a pharmaceutical company, has been approved by the US Food and Drug Administration (FDA). A March 9, 2016 press release explained that the company priced its drugs “to broaden and accelerate access to treatment for patients covered in commercial or public plans, including our country’s veterans,” although a spokeswoman noted that it is too early to predict whether or not Zepatier will become the preferred drug for the VA.