The Biden administration is preparing a comprehensive initiative to fight hepatitis C that would streamline testing and treatment and secure an agreement with drugmakers to bring down the cost of treatment of the disease, which has spiked during the pandemic.
Francis Collins, special project adviser to President Joe Biden and former longtime director of the National Institutes of Health, said Monday the administration hopes to secure some funding this year for the yet to be formally unveiled initiative.
He said he has briefed Biden on the plan, and the Office of Management and Budget is “enthusiastic about figuring out how to fit this into the budgetary requests.”
The plan, he said, would include agencies including the Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration, the Indian Health Service, Food and Drug Administration and the Federal Bureau of Prisons.
“It would certainly involve virtually all of the government agencies that have a major role to play,” he said.
Left untreated, hepatitis C is a chronic condition that can lead to severe liver damage and liver disease. While the advent of direct-acting antiviral drugs can now cure most patients, administrative barriers and cost concerns have limited wider spread usage of the drugs.
A joint report released from HepVu and the National Alliance of State and Territorial AIDS Directors on Tuesday found that one-third of U.S. jurisdictions in 2021 did not have a full-time viral hepatitis surveillance employee and only 55 percent of jurisdictions could produce an annual surveillance summary.
Collins said the plan would include increased investments into hepatitis C surveillance in the hopes of creating a system similar to one tracking HIV data.
Effective treatments of hepatitis C have been available in the U.S. since 2013, but getting those the direct-acting antiviral drugs into the hands of patients has been a challenge. High costs, logistical red tape, and overlapping pandemics have stymied efforts to more swiftly stop the spread of hepatitis C and other infectious diseases.
White House summit
The White House convened a summit on Aug. 23 with agencies and advocates to discuss a national plan to expand hepatitis C treatment availability.
“There was unanimous, strong support for the conclusion that we just ought to figure out how to do this and not wait,” Collins said. “That was gratifying.”
Collins, who most recently was the president’s acting science advisor, is now focused squarely on the hepatitis C project after Arati Prabhakar was sworn in at the helm of Office of Science and Technology Policy earlier this month.
He said the plan “is going to have to involve some upfront expenditure in order to ultimately reap the rewards of reduced health care costs downstream,” but would be economically sensible because it reduced negative health consequences.
“That means basically trying to figure out from the Congress’ perspective is this something that CBO would score as cost savings or is it going to cost money and would there have to be found offsets,” he said. “We don’t have the answer to that yet, but I’m fairly optimistic based on the work that has been done by a couple of experienced economists.”
Eliminating hepatitis C isn’t a new goal.
In January 2021, the Trump administration released the first national viral hepatitis elimination plan, setting a goal of 2030.
“I think this could be done in five years, so that would come in sooner than 2030 but not a whole lot,” Collins said. “No one wants to be realistic about the fact it’s going to be hard. There’s a lot of aspects of this that are going to be challenging.”
Hepatitis C treatment generally begins with an antibody test, which if positive is followed by a blood test for RNA or for core antigens. If those are positive, a patient can return for for antiviral treatment, if eligible.
“We lose a lot of people along the way,” he said. “What we really need is a point-of-care test that has a turnaround in a half hour.”
Collins said a goal is to make it easier for at-risk populations or those who face additional barriers, such as the uninsured, Medicaid beneficiaries, Indian Reservation residents, injectable drug users, incarcerated persons or those without reliable transportation to receive tests and treatment.
He hopes to get funding as early as the fiscal 2023 spending bill to test national pilots of the test and treat model for such populations. These smaller pilots, he said, would let the federal government get its “feet wet” with initial negotiations with drugmakers on “what kind of deal can be made there.”
After a few months of state pilots, the model could be tested to eliminate any roadblocks before expanding to a national level. The plan would mirror many logistics established by Louisiana in 2019. Louisiana uses a Netflix-style subscription — where you pay a set price for as much as you want — to buy an unlimited amount of hepatitis C treatments for Medicaid and correctional facilities from a manufacturer at a fixed price.
Other states have since adopted similar models, and the Louisiana Department of Health announced in June that 11,000 residents have accessed hepatitis medication through the pilot program.
Collins cited Sen. Bill Cassidy, R-La., a gastroenterologist who helped with Louisiana’s plan, as a potential partner in larger efforts.
“There are several barriers to treating patients with hepatitis C, one being the cost of medicine,” Cassidy said. “Modeling shows the possibility that if the cost of medicine were removed as a barrier to treatment, the federal taxpayer would actually save money from the avoided health care cost accrued to Medicare and Medicaid. This is the ideal outcome, saving money for taxpayers by curing fellow Americans of hepatitis C.”
One factor still in flux is establishing what programs or insurance programs would be included under the national plan.
“I don’t see this as something that would take the place of the current system for people who have [private] health insurance,” said Collins. “I think health insurance should cover this if it’s somebody that’s enrolled in their plan. I don’t know that we should imagine the government stepping in to give a windfall to the health insurance industry.”
Collins sees the plan as essential for Medicaid, the uninsured and the federal prison system. He said the Bureau of Prisons has figured out logistics because of involvement in Louisiana but will need help with the health care delivery system. For state incarceration, he sees CDC working to give states grants to administer the program.
Collins said Medicare is less clear, as some beneficiaries already have coverage that would cover the full cost of the drug, and he doesn’t want to “rock the boat” for things that are working. But at the same time, the government does not want other Medicare enrollees to find out the drug comes with a large copay that would exclude them from seeking treatment. Baby boomers are another at-risk group.
John Ward, director for global hepatitis elimination at The Task Force for Global Health, an international nonprofit organization, said state pilot programs like in Louisiana have fueled interest in a national hepatitis C elimination program at the White House level. He spoke last week at an annual meeting of five leading infectious disease groups.
“No one should be dying of hepatitis C anymore, certainly not in the United States,” he said. “I have some hope that we actually can launch a national program that will help create that standard.”