In July 2018, New York Governor Andrew M. Cuomo announced a commitment to develop a strategy to eliminate hepatitis C. The strategy, once realized, would be the first in the nation, and it also included the establishment of a Hepatitis C Elimination Task Force. This elimination effort would aim to stop the spread of the virus by increasing access to medications that can cure hepatitis C and expanding programs to connect New Yorkers with prevention, screening, and treatment services.
Hepatitis C affects more than 200,000 New Yorkers, and yet, the recommendations have yet to be made public after months of delays.
Annette Gaudino, the state and local policy director with Treatment Action Group (TAG), is also a founding member of the Steering Committee of the New York State Hepatitis C Elimination campaign. TheBody spoke with Gaudino about the work to end hepatitis C in New York, and about the delays in publicizing the recommendations.
Terri Wilder: So, you were really there from the very beginning in terms of this announcement. Can you tell me about the history of the campaign and how it started?
Annette Gaudino: Thanks, Terri. I think it’s really important to begin by recognizing that the governor’s announcement is a direct result, not only of community demand for a plan to eliminate hepatitis C in New York State, but community organizing, education, and mobilization to start to develop a plan, even before we got the governor on board.
Back in 2016, when I first joined TAG, there had been some initial conversations between community members, community-based organizations, and the state Department of Health to start thinking about the capability of planning towards elimination in New York State, what components we would need to have, sort of, together in order to start to begin a process about that, and who needs to be at the table. Those processes eventually led to a two-part, multi-stakeholder process in late 2016 and early 2017 that produced an initial draft set of recommendations, over 30 recommendations, that were published and presented in Albany in February of 2017.
We can talk a little bit more about how the second wave of the community mobilization got us to the task force—essentially, when the governor chose to convene a task force and to engage with hepatitis C elimination; but they took the blueprint that we’d already created, the community’s work, and used that as the foundation for the task force and for subsequent work. And that’s the process that we’re engaged in right now.
TW: Great. Fast-forward to current day: The task force was established; it met, both in person and lots of conference calls, to kind of build on that backbone of recommendations that the community put together. What is happening now with this elimination strategy? Where are we now? Have things started moving? Has there been any funding attached to it? Can you give me an update of where we are now?
AG: Yeah. I think there’s three aspects of the effort since the announcement in July of 2018. First is, the governor did include a significant increase in funding for hepatitis C programs in his executive budget, which was then passed and included in the full budget. That $5 million for hepatitis C programs was more than a fourfold increase to the previous funding that we’d had, basically, for decades. That’s an important investment that the governor made, and it was a two-year commitment. We’re hoping to continue that investment and, in fact, build on it going forward.
The second is, once we got everybody in the room together and actually broke out into working groups and started talking about planning processes, and doing sort of a needs assessment, and looking at barriers that need to be removed—again, referencing the community document—immediately, work started happening. You had New York City public health officials and New York State public health officials to work on surveillance systems and backend data sharing, talking to each other and problem-solving, and thinking about ways that we could bring the rest of New York State up to the high standard of data integration that New York City had. We started looking at regulatory issues that—you know, things that we could be moving forward to increase access to providers and to prescribers. And all sorts of work started happening, even before, and in parallel to, the work of just looking at recommendations, and drafting and writing and discussing those concepts.
But then, most recently, while that work is ongoing and those discussions have borne fruit, publicly, the public-facing part of the elimination process kind of just disappeared, and it’s in a bit of a suspended animation, I would say. Since our last face-to-face meetings to share, revise, and discuss all the working groups’ final recommendations, submissions for recommendations—in June of last year, we haven’t really had any subsequent meetings or calls. The recommendations have not been released to the public, even though the positions that were recommended and discussed in that June meeting were pretty minor. The document’s just hidden somewhere. We’re not quite sure why it hasn’t been released to the public. We were initially told the timeline for public release was the fall of 2019—and, here we are, end of January, beginning of February 2020, and we still haven’t seen them.
So, yeah. I’m puzzled.
TW: The task force ended their work in June of 2019. The community was told the guidelines would be released in the fall. It’s now close to the beginning of February, and there’s been no conversation about when, now, it would be released? Or are you just saying we just don’t really know what the answer is?
AG: So, we have not gotten an updated release date from either the state Department of Health or from the governor’s office. We’re not quite sure where we are in the process. There certainly needed to be some internal review by the department, and by the governor’s office, of the work that we submitted. But we just haven’t gotten any real progress updates about where we are in that process or any date where we can expect the public release of documents.
But I think regardless of where things are being held up internally, I think everyone that worked on the recommendations—I know I certainly am very proud of the work that we did; we brought together experts, community members, people with lived experience; we had very, very serious conversations, and we took our work very seriously, and—we want it released to the public. We did this in good faith, and sort of to serve the people of New York State. And we feel—I feel—responsible to the people of New York State to share the work that we did, and to have a public conversation about some of these recommendations.
I don’t think anybody who was engaged in this process thought that we were creating a document that was going to be implemented immediately. That’s why they’re called recommendations. And we really just want to get that process started.
I think, if anything, if we have any weakness in the process in New York State, it’s been a lack of direct community engagement, or widespread community engagement, especially in contrast to some other jurisdictions that are doing hepatitis C elimination work—I’m thinking specifically of San Francisco—but also, generally speaking, in comparison to HIV, when you look at all the structures and spaces and places that people living with HIV have to talk to public health officials, to share their experiences, to work in partnership, to have their needs met, and to advance care and move towards an AIDS-free world. We just don’t have that infrastructure yet for hepatitis C in New York State, and it’s going to take a lot of work to build that. So, it would really be helpful to have these recommendations as a focal point for having and expanding those conversations.
TW: On Jan. 22 of 2020, groups like VOCAL; your organization, TAG; Housing Works; and other groups in New York State gathered in Albany, New York, for a rally and legislative visits. What were some of the asks of elected officials as it related to hepatitis C elimination?
AG: A longstanding budgetary ask that we’ve had, again, dating even prior to having the DAA vote, the new very powerful curative treatments for hepatitis C, is around $10 million. Just to put that in context, New York State is roughly the same population size and GDP as the country of Australia, and we have a similar hepatitis C burden. Australia has made a significant commitment to hepatitis C elimination and is going to meet global targets for elimination in 2026.
So, $10 million to serve a population of 20 million New Yorkers, and really be aggressive towards ending this epidemic, is a very small investment. We’ve been fighting to get to that number. That $10 million figure is really just making up for years of flatlined funding; it’s not really what we need for elimination. We need to do a little bit more work to figure out what we need, truly need, to get to elimination.
So, our budgetary ask was first and foremost, but we also talked about these new recommendations, public release of these recommendations a lot of months later, and just making them aware that this process had happened, that these recommendations are in draft form, ready to be released and discussed but haven’t been; and just trying to get them to understand where we are in this and try to kickstart a little bit more momentum in the process. Because it seems to be a little bit stalled.
TW: Is there anything that you can recall in these recommendations that might be controversial that may be somehow impacting them not [being released]?
AG: Yes. I want to respect the process, and I want to respect my other task force members, and the work that we did, again, in good faith, and not sort of pre-empt the release of these recommendations when people are ready for them. But I will say this: There is a national conversation happening right now around evidence-based interventions to prevent the spread of infectious disease, and also to prevent overdose—specifically with regard to opioids, but other drugs, including those that are injected—that includes measures such as safe injection facilities or safe drug-consumption sites. Again, this is a big national conversation that’s happening.
In some corners, particularly places that don’t look at the evidence for what’s effective, these measures are controversial. For folks who find safe consumption spaces and safe injection sites controversial, it’s not going to become less controversial by waiting to debate those issues.
So, to the extent that those kinds of evidence-based recommendations could potentially be holding up the release of these recommendations, that’s not a good rationale. There’s no reason to avoid a debate, and there’s nothing to be gained by delaying that debate. I think I’ll just leave it at that.
TW: What is happening in New York in terms of the hepatitis C epidemic as the community is waiting for these guidelines to come out? Are things getting worse? Is potential money not being distributed?
AG: Thanks for asking. There’s a whole—first, I’ll talk about some services that have gone out to the community, as a result of this increased investment, that are very, very positive and exciting; and also some interesting figures from the most recent statewide surveillance report that I was just reviewing this morning.
First off, the $5 million that we got has been invested in such innovative programs as providing confirmatory diagnosis and treatment initiation at harm-reduction sites. We’re talking about syringe service programs and places where people who are actively using drugs, including injection, are able to get services to prevent and reduce the harms from their substance use. But also now through increased investment and some regulatory changes, those harm-reduction sites are being able to get an RNA confirmatory test for people—that’s the required test to make sure that the person actually has the hepatitis C virus, who wasn’t just exposed in the past and cleared it on their own—and get all the other tests that they may need to find out if they have any liver damage, find out what genotype they have of the virus, and prescribe them, and start them, and see them through treatment.
We’re not going to really see the fruits of those programs for another couple of years, because they’re just getting off the ground. They’re pilots. But this model has been used in multiple settings across the world. And so we have every reason to believe that it will be just as successful in New York City and New York State as it has been in other countries.
Second, in reviewing some of the related figures coming out of the state surveillance system for new cases, we have seen a downtick, a decrease in the number of new acute and chronic cases of viral hepatitis C in New York State from between 2016 and 2017. Now, it’s just one year; it’s not a trend. I don’t think we can say with confidence what we can attribute that downturn to. It could be new programs. There might be a known factor, such as people not accessing services due to, for example, fear related to their immigration status. A lot of the rhetoric around public charge is really driving people away from the health care system.
It’s just a very complicated story, and so I wouldn’t speculate as to the reason why we’re seeing fewer reported new cases of viral hepatitis C in New York State in 2017—and, again, it’s only one year, not a trend. But I think it’s obviously something to watch out for, and it will be interesting to see what the 2018 numbers look like and whether this trend carries through, and to start to dig into the data, look to see if these programs are having an impact.
This is the kind of work that we need to be doing as we progress, as we try to live up to this commitment that we’ve made to New York to eliminate hepatitis C. Like, let’s get started. This is the work right here.
TW: Are things like prior authorization still a challenge in accessing care?
AG: Yes. Absolutely. One thing to note is the DAAs, the direct-acting antivirals for hepatitis C, are very, very easy to administer. New York State actually has a very robust clinical education program to get primary care providers, including any prescribers, including nurse practitioners, comfortable with administering these medications to folks who do not have advanced liver disease. If you have advanced liver disease, obviously you should be seeing a specialist. But for most patients who do not have advanced liver disease, these drugs are very well-tolerated, and the majority of patients can be cured in as little as eight weeks.
Requirement for a prior authorization that needs to be approved by a provider before you can start your treatment is not clinically necessary. Basically, prior authorizations were put in for hepatitis C treatments when the treatments launched at these very, very high prices. It’s another way to limit access and to control costs. Not only is that not the case anymore—because, in addition to some more competition in the marketplace, mandated Medicaid discounts and years on the market can create additional discounts—price should not be, and is not really, we’re told, a barrier to starting initiation. The Medicaid budget is not being busted by hepatitis C meds. Don’t let anybody try to convince you otherwise.
We have all the pieces in place to have widescale universal access to anybody who’s living with hepatitis C to these medications. Prior authorizations should be removed.
I will note that two states—Louisiana and Washington State—have recently made volume-based deals for DAAs. As part of their negotiating process for the deal that they cut, removal of prior authorizations was something that the manufacturers asked for and got. And the state of Massachusetts never instituted prior authorizations for DAAs at all. Those are just examples showing that prior authorizations aren’t necessary. It’s kind of low-hanging fruit, a barrier that we should be removing in New York State, I would say.
TW: What about stigma, in terms of people accessing care? Is stigma still something that’s a concern? Is it a barrier? Does it prevent people from accessing care to be found—you know, to know if you have hepatitis C?
AG: Stigma is absolutely an issue and a barrier to care for people living with hepatitis C. It’s complicated. I think there are at least two main components to it. One is the association with injection drug use and the
stigma that goes with drug use, and the criminalization of drug use. But also, I think, there’s just people feeling stigma due to lack of information.
For example, I attend multiple meetings, community listening sessions, with peer educators and with community members who were living with hepatitis C and were able to get cured, to learn from them and hear their experiences. And one really stands out to me.
A gentleman was telling me that he lives with his brother and he cannot—doesn’t feel comfortable, doesn’t feel safe, telling his brother about his truth with viral hepatitis C, even though he’s been cured. He had a hospitalization and was anxious and terrified that his provider would reveal that he was antibody positive for hepatitis C—meaning that he had been exposed in the past—because he was afraid of how his brother would react, and potentially ask him to leave his living situation; kick him out. And, again, this is someone who has been cured. He just could not have a conversation. It’s just that feeling of, you know, I guess, being “dirty” and being “infectious,” and being a danger to the people around you.
And also, just with regard to accessing care, people feeling that they’re not worth the care. Things like prior authorizations; things like restrictions for people who have issues of substance use; when those drugs first became available, you had to have advanced liver disease to even request a prescription. All of that sends a very strong message to folks that their lives aren’t worth it, that they don’t deserve care, they don’t deserve health care, they don’t deserve the cure.
That is not something that can be unwound and undone just in one clinic visit. That takes time. Trust has been violated, and harm has been done.
So a lot of the work that is happening right now in terms of finding people is just getting peers working with folks in the community, just to get them to trust them and to trust the health care system, so that they can access care. Stigma is huge and not an easy thing to deal with. And we should probably be putting more resources into dealing with it, rather than asking peers and navigators to jump through prior authorization loops or having community members have to do advocacy every year just to fight for small increases, relatively small increases, when you think of the total New York State budget, to get these programs and to get the cure that they need delivered.
TW: You mentioned at the beginning that essentially the viral hepatitis response had kind of been flat-funded for nearly a decade. And so it’s a little shocking to think about that prior to 2018, the New York State Department of Health viral hepatitis response had been flat-funded at just over a million dollars a year.
TW: And when you think about the fact that you can cure this disease now, you could really eliminate it—because there is a cure—and the fact that you and others going to this awareness and legislative visits were asking for an additional $10 million in new hepatitis C funding to really cover the critical prevention, health care, and treatment services. I’m just kind of wondering, in a legislative environment in which you talk to elected officials and they say things like, “Oh, the budget process is a ‘bloodbath’ and people aren’t going to get what they want,” what was the reaction to when you had your elected official visits and you said, “We need an additional $10 million in new hep C funding?”
AG: Well, one thing I’ll say up front is that the New York State budget is not going to be balanced or go into deficit due to $10 million. This is not what’s going to make or break the New York State health care budget—which is in the billions.
Right now, the governor unfortunately is being very aggressive in framing what I and other advocates are calling a manufactured crisis around Medicaid costs. And so, I think that that’s by design in order to prevent these kinds of—the needed increases that we need on the programmatic side to get people linked to care, and to make the best use of our health care dollars. Not investing in peer educators upstate to find, screen, diagnose, and link people to care who have hepatitis C is a missed opportunity, not only to get them cured of their hep C, but to make sure that their HIV, if they have HIV, is managed.
Do they have hepatitis C virus that needs diagnosis and treatment? How can we support them to reduce or use more safely substances that they may be using? How can we get them into counseling services? It’s just, it’s penny wise and pound foolish to be spending billions of dollars in Medicaid and not investing, you know, mere millions for very cost-effective, relatively inexpensive interventions that are just about putting people into communities to help people.
The governor has touted his commitment to end HIV. And it did absolutely catalyze a lot of activity outside of New York State when New York State made their bold move in 2014. Hepatitis C advocates certainly tried to walk that path and follow that model in trying to get the more political will engagement and commitment with regards to viral hepatitis. And we kind of won that fight. But we’re still—the commitment is, pardon my French, it’s half-assed at this point. We need to live up to the words from the statement. We call the governor to live up to the words of his statement and put some weight behind his commitment by making modest investments and helping us get to where we need to go.
We’re ready. The community is ready. The Department of Health is ready. The providers are ready. Certainly, people who are living with viral hepatitis C are waiting. Like, let’s get it done.
TW: Great. Well, thank you so much for talking with me. If folks want more information about what’s happening in New York in terms of hepatitis C elimination, what would be some good resources for them?
AG: You can certainly visit Treatment Action Group’s website. I’d also invite you to take a look at VOCAL-NY, and Housing Works, and Harm Reduction Coalition. And, in addition, the Coalition for Positive Health Empowerment and Hepatitis C Mentor and Support Group. All those organizations are the core peer community members of the hepatitis C elimination campaign here in New York State.