With an $11 billion price tag, the White House pitches a plan to end hepatitis C

White House science adviser Francis CollinsPATRICK T. FALLON/AFP VIA GETTY IMAGES

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, including everything from purchasing pricey drugs that cure the condition to developing new tests to detect the infection, 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. Francis Collins, the White House official behind the plan, has previously said it would save more than 100,000 lives by 2050.

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.

“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.

Multiple hepatitis C advocacy groups, including the Coalition for Global Hepatitis C Elimination and the National Viral Hepatitis Roundtable, are now urging lawmakers to see beyond the initial price tag and fund the project. “This effort would save countless lives, improve health equity and set an example for the world,” wrote the Coalition for Global Hepatitis Elimination in a statement.

Related: DEATH SENTENCE: An 8-part investigation into prisons’ refusal to treat hepatitis C

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. However, the requested funding would be “split between multiple agencies,” Collins told STAT.

The plan itself would have three priorities. The most notable 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.

Collins told STAT Friday that roughly $8 billion of the $11 billion in funding will go to procuring those drugs, though that price tag could end up being reduced depending on negotiations between drug makers and the federal government.

“Until the negotiation with Gilead and AbbVie has taken place, we don’t really know what that number will be,” Collins said. “I believe there is a significant chance it could be lower than this.”

Collins also argued that much of that money would be spent anyway “in continuing the current pace of Hep C treatment, but in a much less effective way without the subscription model.”

The second priority 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.

Related: Science adviser Collins hints at a big White House ask to eliminate hepatitis C

The third pillar of the plan would be a public health campaign to increase testing and treatment for the virus. Collins and Fleurence note that the plan will likely include efforts to ramp up testing of the virus, including “using networks of pharmacies where possible.”

This article was updated to include further information about exactly how the $11 billion would be spent and how the program would benefit broader public health goals.

Original Article: https://www.statnews.com/2023/03/09/white-house-hepatitis-c-11-billion/