Tuesday , 21 May 2024
Home Health Transcript: Hepatitis C Briefing | CDC Online Newsroom
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Transcript: Hepatitis C Briefing | CDC Online Newsroom



00:00

For standing by. At this time all participants’ lines are on a listen only mode until the question and answer session of today’s call. It is also being recorded. If you have any objections, you may disconnect at this time. I will now turn the call over to Benjamin Haynes. Sir, you may begin.

00:18

Thank you Christy. And thank you all for joining us for today’s briefing to discuss CDC’s most recent analysis of U.S. hepatitis C data. We’re joined by Dr. Jonathan Mermin, Director of CDC’s National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention. Dr. Carolyn Wester, Director of CDC’s Division of Viral Hepatitis and Dr. Francis Collins from the National Institutes of Health, who serves as the lead for the White House’s National Hepatitis C Elimination Initiative. Following their remarks, we will open up the lines for your questions. I will now turn the call over to Dr. Mermin.

00:57

Thank you, Ben. And good morning, everyone. And thank you for joining us today. So to understand the gravity and the importance of today’s findings, I’d like to start with some background. CDC estimates that more than 2 million people in the United States have hepatitis C. It’s known as the silent killer because initial infection usually has few to no symptoms. But over time, the virus can slowly cause damage to the liver. It can cause liver cancer, liver failure and death. And this means that there may be up to a million Americans who don’t know they have a hepatitis C virus even though it is potentially causing severe disease. Nearly 10 years ago, medical researchers developed several highly effective cures for hepatitis C. The nation had in our hands the key to preventing tens of thousands of cases of liver cancer, liver failure and deaths from hepatitis C. And yet, today nearly 15,000 Americans die annually for hepatitis C. These deaths could have been prevented. Thousands of people are dying every year in our country, and many more are suffering from an infection that has been curable for over 10 years. So the data we will present today shows that only 1/3 of people diagnosed with hepatitis C have been cured.

The barriers preventing breakthrough treatments from reaching the people who need them are not inevitable. This is mostly because insurers have placed obstacles in the way of people and their doctors preventing patients from accessing treatment. It is time we remove these barriers and expanded public health systems to prevent new infections. Eliminating hepatitis C would be cost saving and lifesaving. And I’m honored to have Dr. Francis Collins here with us today to discuss how we can address these challenges through the President’s proposed National Hepatitis C Elimination Initiatives. And now I’d like to turn the mic over to Dr. Carolyn Wester, the director of our division of viral hepatitis at CDC, and she’ll provide more detail on today’s report.

03:23

Thank you, Dr. Mermin. And thank you all for joining us today. The study released today uses commercial laboratory data from more than a million people nationwide who were diagnosed with hepatitis C between 2013 and 2022. As Dr. Mermin explained, this period is significant as it represents the first 10 years since safe and highly effective cures for hepatitis C became available.

This study provides data on the percent of people with hepatitis C who cleared the virus, an indication of being cured. This analysis also provides the first clear picture of hepatitis C treatment among people without health coverage. We found jarringly low cure levels across the board for people diagnosed with hepatitis C. Overall, only one in three people diagnosed with hepatitis C were cured, and only one in six adults under the age of 40, without health coverage, were cured.

The highest cure rates were among adults 60 years and older who had Medicare or commercial insurance, yet less than half of these folks were cured. Today’s study shows that nearly a decade after highly effective cures became available. The vast majority of people with hepatitis C have not been cured. So why is this? There are multiple reasons. I will highlight two. First, health coverage policies often make it difficult for people with hepatitis C to access treatment. Due to the high cost of treatment, some payers limit which patients are eligible for treatment or require burdensome preauthorization before treatment can begin, or even limit the types of providers who can prescribe treatment. All of these restrictions can delay or even prohibit access to these lifesaving medications. Second, as Dr. Mermin mentioned, Hepatitis C is a silent killer, and many people don’t even know they have it. In fact, we estimate that about 40% of the people with hepatitis C are unaware of their infection. So while this study looks at treatment gaps among people with diagnosed hepatitis C, there is also a great need to increase screening and testing for hepatitis C. CDC recommends that everyone be tested for hepatitis C at least once in their lifetime. Overcoming these barriers can make the difference between life and death. Everyone with hepatitis C deserves the chance to be cured.

I’ll now turn it over to Dr. Francis Collins to discuss how we could address some of these barriers through the proposed National Hepatitis C Elimination Program.

06:03

Well, thank you, Dr. Wester. How often do we have the chance to eliminate a terrible disease that has already taken way too many lives, and to do so with a simple oral therapy that has very few side effects? We have an opportunity to do something truly historic. The CDC report you’ve just heard about highlights an urgent need for a bold response to hepatitis C.

And the cure that’s been available now for 10 years is very simple, one pill a day for eight to 12 weeks, very limited side effects. A lot of people remember the bad old days when the treatment for hepatitis C was very toxic and didn’t always work, involving interferon. That is not the case now. The available cure is both safe, highly effective, and very well tolerated.

So we have the tools to win a victory here. And that’s what I want to tell you about right now. It’s called the National Hepatitis C Elimination Program, proposed by the Biden Harris administration, and now seeking support from the U.S. Congress. The program will prevent cases of liver cancer and liver failure; it will save 1000s of lives, and importantly, it will be more than paid for by future reductions in health care costs by preventing tens of thousands of cases of liver cancer, liver failure, and even diabetes and kidney failure, which are part of hepatitis C as well. That will add up to a huge amount of cost savings downstream. Why aren’t we doing this already? Well, there’s several barriers. One is the cost of the therapy has been a real barrier to many programs. Medicaid programs are reacting to the initial costs of treatment, which were in the neighborhood of $90,000 for patients, are put up barriers. And while that cost has come down somewhat now to $20,000 to $24,000. This still represents a major obstacle for Medicaid programs. So many of them in the states still require evidence of liver disease. Does that make sense? We’re trying to prevent liver disease, or they require sobriety or they require a specialist has to be involved in a circumstance where testing and treating are actually pretty straightforward.

Medication costs have particularly been a problem for the uninsured who may get their care through a community health center that doesn’t have the resources to necessarily cover this high cost. In prison systems, where as many as 30% of inmates may be infected with hepatitis C, the resources in the staff assistance to test and treat are often not present. And for Medicare, which covers the costs theoretically, you’ve seen the data that less than half of Medicare patients who are known to be positive, get cured. And of course, there probably many others that haven’t actually found out their infection status because Medicare patients have one reason that, maybe this is an obstacle, is that co-pays can run as high as $4,000.

So the program proposed by the president has an innovative model to deal with the cost issues. And this was piloted in Louisiana, and quite successfully so, and it’s called a subscription model. Some people have called it the Netflix model. When you sign up for Netflix, you pay a lump sum, and then you are able to browse as many films and shows as you want to without paying any additional funds. Louisiana went to Gilead, one of the manufacturers along with Abbey and said, “How about this? We’ll give you a lump sum and now you can then, after that, make the drug available essentially for free to anybody on Medicaid and anybody in the federal prison system. And guess what? It worked. If it worked in Louisiana, why not in the United States?

The proposal here is that such a negotiation would be done with the companies that have the FDA approved oral therapy. Gilead and Abbey agreed to a lump sum and then they would make the drugs available for free to anybody on Medicaid, who’s uninsured, who’s in the prison system, or who’s on the Native American reservation where Hepatitis C is also a significant problem. This can be a win, win, and save lives and remove a major obstacle to getting those, over 2 million people who are known to be infected, access to the cure.

But that’s not all. Another critical step is to increase the awareness of infection. You heard from Dr. Mermin that many people don’t know they have this and don’t have symptoms to cause them to go get tested. Even though CDC recommends that everyone gets tested for hepatitis C, at least once in their lifetime, only a minority of Americans have done so. One of the reasons is that testing can be cumbersome. Effectively, you need first an antibody test and then an RNA test, and those have to be sent away to central laboratories, so there can be a long delay, and we lose a lot of people along the way.

A rapid point of care test as is already available in Europe, Australia, and a few other places could change all of that. And so an active effort is underway right now, working with NIH and FDA to get approval of that point of care test in the U.S. a test that gives a result in an hour or less. The goal being then to get test and treat done in a single visit. That is the way we really can address this most successfully. But then having the technology and reducing the cost while good are not quite sufficient. We will also need a well-funded comprehensive public health effort to expand prevention, provider education, testing and treatment to more settings. And that is also part of the plan that is fully fleshed out by the administration. And that plan has included our CDC colleagues who are speaking today, and numerous other senior leaders at HHS who are fully behind this, as well as the Bureau of Prisons. So the President has asked Congress to front load this bold five year initiative, with five to $6 billion over the current expenditures on hepatitis C. That’s a significant investment. But really importantly here very sophisticated economic analysis by colleagues at Harvard and USC estimate that initiating this program would save the federal government more than $13 billion dollars just in the first 10 years, and 44 billion in 20 years–savings that come about because we won’t be having to pay for very expensive liver transplants, treatments for cirrhosis, and treatments of liver cancer, as well as cases of diabetes and kidney failure that can be prevented if people get cured now of this viral disease. This is compassionate care. But it can also contribute to deficit reduction. If other countries like Australia, Egypt and the United Kingdom can do this, and they are, why not the United States? Do we want to be last here? It’s rare, in my experience, to have an opportunity to both save lives and save money, but that’s exactly what this is. I don’t know too many people who have looked at this situation and not felt like we have to do something. You can’t know about this and just walk away. How can we not do this? Let me turn this back over to Dr. Mermin.

13:47

Dr. Collins, we can save lives prevent suffering and save money. How can we not do this? So CDC is proud to have played a role in the development of the National Hepatitis C Elimination Program, and we continue to work every day to reduce hepatitis C in the United States. And I believe no one should have to live knowing a cure for their potentially deadly disease is available, but out of their reach. I also believe that our nation should seize the opportunity to become a world leader in hepatitis C elimination. A new cure for deadly disease calls for a game changing response and that’s exactly what we must do. So thank you all. I’m going to turn the mic back to Ben Haynes.

14:29

Thank you Dr. Mermin. Christy, we are ready to open up for questions.

14:44

Thank you. At this time if you would like to ask a question, please press star one on your phone. Please ensure that your phone is unmuted and state your name clearly when prompted. Again that is star one to as a question. One moment.

15:19

Our first question comes from Gabrielle Wanneh of Inside Health Policy. Your line is open.

15:34

Ok, thank you for taking my question. In regards to the subscription based model, I have a question about where that model currently stands since it was first announced that that is what the President wanted to move forward with earlier this year. What? Where does that stand at the moment?

15:59

Francis Collins, I can respond. It is part of the President’s proposal of this national initiative, along with the other components that I mentioned, such as proving the ability to do point of care testing, and for more in the way of healthcare delivery in places where it’s needed for people with hep C. This is now under consideration by the Congress because, of course, that’s how things get done. And the administration has made that proposal that Congress is looking at it in a subscription model is a significant part of that. And I think many people consider it also a particularly creative approach that is likely to reduce the cost substantially per patient, for being able to make the drug available. But all of that now depends upon how the Congress will review all this proposal and how in what we hope will be a bipartisan way since this affects so many American lives, find a way forward to make it happen.

16:58

Next question, please.

17:13

Our next question comes from Sandhya Raman as CQ Roll Call, your line is open.

17:21

Hi, thank you so much for doing this call. I guess I wanted to piggyback kind of on the last question Have you gotten any support from Congress on being able to fund and implement this plan? And I guess if they if they don’t, aren’t able to this year is there part of it that you’d be able to implement without a significant bump in funding? Thank you.

17:45

Dr. Collins, I’d appreciate your answering that one too.

17:48

Sure, glad to. There is interest in the Congress, both the House and the Senate, across parties. But it is still not to the point, I think, to be able to say exactly how that is going to take shape. A lot of this depends upon the specific legislative language and also what the Congressional Budget Office will conclude as far as the cost issues because that’s obviously something everybody’s waiting for. I will say, it’s important to note that one of the leaders of this Louisiana pilot that we are encouraged by is none other than Senator Bill Cassidy of Louisiana, who is a physician. In fact, he is a physician with expertise in liver disease, that’s his specialty. And certainly working with him and his staff over the course of the last year has been critical in shaping this effort. Also, in the House side, Congressman Hank Johnson has been a strong supporter, Democrat from Georgia. He is himself a hepatitis C survivor, knows what this disease is like, and has also been very willing to be very public about that and to encourage his colleagues to look at this. So I think there is reason for us to be optimistic that this could happen. And I’m not ready yet to talk about what we might do if it didn’t. One of those folks, once I’ve seen the opportunity here, it’s hard to do anything other than push in absolutely the best way we can to get it to take shape in the full fashion that it means if we’re going to find a test, treat and cure those more than 2 million people who are depending on us.

19:27

Next question, please.

19:33

Thank you. Our next question comes from Arielle Dreher of Axios. Your line is open.

19:41

Thank you for taking my question. I’m curious does the Biden administration’s budget request includes ways to bring down co-pays for treatments for people who have health insurance or Medicare coverage.

19:55

So again, this Francis Collins, yes it does. A part of the proposal is focused on those individuals who are not in the lowest income status where in fact, co-pays are generally not present for something like this. But just the bracket a little bit above that where co-pays can in fact be several thousand dollars. The proposal is to try to provide relief for those individuals so that that is not such a huge deterrent to getting the cure.

20:29

Dr. Mermin, did you want to add to that?

20:30

Just I appreciate the thoughts and just wanted to emphasize that only one in three people hepatitis C have been cured. And we need a transformative national response to prevent what we all know are needless suffering and deaths from hepatitis C and potentially save tens of thousands of lives and tens of billions of healthcare dollars for the country.

20:57

Christy, I think we have time for one more question.

21:02

Thank you. We do have another question from Gabrielle, Gabrielle Wanneh of Inside Health Policy.

21:24

Okay, the second question I wanted to ask about, within this initiative, what is the action plan for getting insurers to kind of lift the restrictive policies that they tend to impose on patients seeking Hep C treatments? I know that this whole thing is still under consideration but what kind of is the plan set in motion for that should this all be able to move forward?

21:52

So that’s a great question. The subscription model that we’ve been talking about, again, would have the federal government agreeing to fund this through a lump sum to the providers of the drugs, and then the drugs being free to patients who have Medicaid, or who are uninsured, or who in the prison system, or who in the Native American reservation. As part of that, we would expect that those organizations would drop all of those barriers, in turn for getting access to free drugs, because the main reason the barriers have been there is for the reason that they couldn’t afford this. So that would be the bargain. I can’t tell you exactly what will happen. However, with private insurance, we don’t aim to influence that with this particular proposal. And it is a concern that private insurers have also, in many instances put up such barriers, such as the requirement to see a specialist. We would certainly hope that with a national initiative of this sort, making the point that everybody should be tested for hepatitis C and if positive should get access to the cure, that that would improve the outcomes for anybody, regardless of what payer is responsible for their care. But that, of course, will be up to the private sector to figure out how to respond to.

Thank you.

23:16

And then just to add on, there are a number of state Medicaid programs and private insurers have been loosening up and removing some of the restrictions over time. Some of that is because the cost of the medication for hepatitis C cures has dropped so dramatically, by, you know, to almost a fifth of what it was when they first came out. And so the initial response to put in obstacles has been rethought by some of these insurers and, and their patients are now being able to access the lifesaving treatment easier than it was a few years ago.

23:55

Thank you. Good point.

24:00

Thank you, Dr. Mermin, Dr. Wester, and Dr. Collins for joining us today. If you have further questions, please feel free to reach out to the main media office at 404-639-3286 or you can email media@cdc.gov. Thank you



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