WASHINGTON — The Biden administration is calling on Congress to fund a more than $11 billion program to eliminate hepatitis C in the United States.
It’s a significant price tag for a single line in the broader budget request; while the $11 billion ask would cover five years of the new initiative, it still dwarfs the annual budget request for the entire Food and Drug Administration, at $7.2 billion. The annual request for the Substance Abuse and Mental Health Services Administration also comes in below the hepatitis C topline, at $10.8 billion.
The White House is also already working to soften the blow of that expensive price tag, arguing the program would eventually save the government money because it would ensure the government wouldn’t have to pay for care for some of the disease’s more serious side effects. The program overall is expected to cost $5.2 billion over 10 years after accounting for the reduced health care costs. The bloodborne infection, if left untreated, can lead to liver cancer and even death.
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Since late 2013, there’s been a simple, easy, daily-pill treatment to cure hepatitis C in a matter of weeks. However, those most affected by the virus are among the least likely to receive that treatment, which costs roughly $24,000 per person. A recent STAT investigation of incarcerated people, a population with far higher than normal rates of hepatitis C, found that more than 1,000 people died of hepatitis C-related complications in the six years since curative drugs hit the market.
The push for a national hepatitis C plan was rolled out as part of the Biden administration’s 2024 budget request. Congress will still have to fund it.
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“It is rare to have the opportunity, using a simple and safe oral medication, to eliminate a lethal disease. But that is the situation facing the United States with hepatitis C. Congressional support can make possible a historic public health initiative that can prevent suffering, save lives, and ultimately save money — to the benefit of all US residents. How can we not do this?” White House officials Francis Collins and Rachael Fleurence wrote in an op-ed Thursday pitching the idea.
Responsibility for the national effort would rest with the Office of the Assistant Secretary of Health, a little-known office within the federal health department currently headed by Adm. Rachel Levine.
The plan itself would have three priorities. The first is to speed up development of tools to rapidly detect the hepatitis C virus, akin to the tests currently available for Covid-19. Currently, those seeking hepatitis C treatment need two separate tests, which typically require two separate appointments with a doctor, before starting treatment. The administration is already using a National Institutes of Health program set up during the pandemic to hasten better hepatitis C diagnostics.
The NIH website is accepting applications from test developers who believe they can create a so-called point-of-care hepatitis C test.
The second priority is finalizing a national “subscription model” that would be used to lower the price of drugs that can then be given to those who otherwise would be unable to afford them. Collins and Fleurence name Medicaid beneficiaries, incarcerated people, people without insurance, and those treated through the Indian Health Service as populations that would benefit from the drugs purchased under the subscription model.
Under that plan, the government would be able negotiate a fixed price for an unlimited amount of hepatitis C drugs. The government would not warehouse the drugs but would negotiate the terms of the deal for the other entities, like state Medicaid programs, Collins said earlier this week at a STAT event previewing the plan.
If implemented, the subscription plan would be the first nationwide test of that drug pricing model, which has been piloted in three states with mixed results. A contract of that size could also mean a major windfall for drug makers. The Biden administration has not yet begun negotiating that contract with either of the two main manufacturers of hepatitis C drugs, Gilead or AbbVie, but the drug makers are “extremely interested,” Collins said at the STAT event.
