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Interview

HIV Activists Launch #BreakThePatent Campaign and National Plan for Generics and Lower-Cost Truvada for HIV Prevention in the U.S.

August 7, 2018

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TW: The document says that [Gilead's] advancing access copay program is insufficient, given the high cost of Truvada, because it only covers $4,800 of the out-of-pocket costs and, until recently, it was only $3,600. Only because of pressure from advocates was that even increased.

ES: It's also that, when the drug costs $1,600 a month, then that copay assistance program can only cover, what? Like, six months' worth of PrEP -- or less -- which is a problem, as well.

TW: At the very end of the document, you guys talk about this case for government action and a National PrEP Access Program. And so, talking about the need for a national PrEP program -- what does that look like to you?

JW: I think the national program would be like a PrEP drug assistance program. So like what we started in New York, like the PrEP-AP: a national program in which not only do we ensure that folks who really need and desire and want PrEP can have access to it, but also, the national program would ensure that they also have access to the doctors, right?

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Because, you know, that care and being engaged with your doctor is also a critical component. So, to answer the previous question, the reason why the Gilead copayment assistance program isn't sufficient is because folks can't afford to go to the doctors to maintain their care, right? So, it just pays for the drugs, but not any of the other services that are needed and that are required to be on PrEP. That's one of the reasons why the Gilead program is insufficient. So, a national program would help to support and supplement that, to ensure that folks not only have access to the drug but also can have continual access to the doctors and providers that are needed to ensure that they remain safe on PrEP.

TW: Including nurse practitioners, physician assistants, etc.

JW: Yes, all that. Right.

ES: And even things like getting an Uber, or a car, or a ride to your appointment, or to your doctor's office. Because that's a barrier for a lot of people, too.

JW: Particularly in the South.

ES: Right, exactly. Particularly in the South and in rural areas. That's also one of the things that the whitepaper talks about.

TW: Yeah. We also have a problem with medical providers, in general, being aware of PrEP. Since Truvada was approved for PrEP in July 2012, having health care providers aware of it, but then, after they're aware of it, being willing to prescribe PrEP. Because some providers think, "Oh, that's an HIV specialist issue," when most of the activists that I've interacted with have said, "No, PrEP is a primary care issue; it should be part of primary care." So anyone should be able to prescribe PrEP. We have [Centers for Disease Control and Prevention] (CDC) guidelines on it and, in New York state, New York state has their own PrEP guidelines.

It's about, in some ways, getting the pen to hit the pad -- as in, the prescription pad. It sounds like PrEP is complicated and takes a lot of choreography.

ES: Yes. But if we can do it with treatment, why can't we do it with PrEP? It's definitely possible, and it's necessary. But we just need to organize to get there.

TW: Right. At the end of this document, you do an analysis of the clinical and drug cost of a national PrEP program and really break it down in terms of an estimated cost of Truvada and clinical care per person, looking at the Medicare fee schedules and the CDC PrEP clinical guidelines to come up with this estimate. That is amazing that this is in here. So, a 30-day supply of Truvada is like $9.70; 12 units per year, so the annual cost is $116.40.

Then, you add in a fourth generation test, four times a year; renal function, two times a year; sexually transmitted infection test, which is part of guidelines, two times a year; a pregnancy test if you're a person who could get pregnant, four times a year; and then a physician visit cost, which is four times a year. So, a total cost of $1,227.61 -- which, if the drug, as it currently stands, is $1,600, that doesn't even include all these other costs that go into having PrEP being part of your clinical care.

Because it's not just the prescription: You have to go see the prescriber. You have to get an HIV test, because this is for people who are HIV negative. If they test positive, obviously, they would start hopefully on antiretroviral therapy immediately.

That's a great document for people to look at. And you can literally see the savings in writing.

ES: Yeah, exactly.

TW: The other thing that was interesting about this document was that you talked about what could you do with the savings. So, if the $1,600 got down to what you are advocating for, there would be potentially $50 million that could potentially help raise awareness about PrEP to priority populations.

Right now, it doesn't feel like we have a coordinated way in the United States to raise awareness about it. The CDC obviously does some, but a lot of community-based organizations are trying to find smaller grants from the Department of Health, or a foundation or whatever, to put together a campaign. And you usually only have enough money to target one population.

In terms of money to raise awareness, what would that look like to you?

JW: Great question, you know? Great question. Because I was just watching a video last night of three guys from a ballroom scene, talking about PrEP. And you could see how much information was misinformed, how much information that they did not know, and how much inaccurate information they had about it. I think having money for campaigns and for public education is critical and crucial and is definitely needed, and definitely making sure that it reaches a diverse audience.

I think even what we saw in New York is that HIV infection among women went up. Because women directly said what they saw in the messaging was that PrEP was not for them.

So, making sure that we have messaging, diverse messaging, that reaches all populations in a way that is not stigmatizing at all is very crucial to ensuring that folks get accurate information about PrEP and feel like it's for them.

So, with that, what would a campaign look like on a national level? I'm not too sure yet. But I know that it definitely should be accessible to all communities, that it should be destigmatizing and help and encourage community conversation at a very local level. That's what I would see from a national campaign.

TW: Yeah. I'm glad you brought up that point about women, because so often women are not included in the conversation about PrEP at all. And, yeah, those messages? You see them up, like you said, in New York City; there's a lot of stuff happening; [you] see posters in clinics. Maybe, if you're lucky enough to live in a city that has a campaign that's more public, on a subway or a bus stop, or whatever. [But] they're overwhelmingly not targeting certain populations and, particularly, women.

ES: That's especially important, too, when we're talking about sex workers. Sex workers are a key population here that needs to have access to PrEP and so, seeing them represented, and seeing more women represented, as well.

TW: Have you met with Gilead about your concerns? I mean, do they have a copy of the paper?

JW: We haven't met with Gilead, but I'm sure they know of our presence. I think they're probably going to pick up our whitepaper. I'm sure they'll see it.

TW: I guess the overall thing driving this is that there are very high prices for this in the [United] States. And then, we have current low rates of PrEP utilization, which is problematic.

Where does the U.S. government play in enforcing the people's right to health and making sure that PrEP is widely available to all Americans?

ES: The U.S. government tomorrow could step in and say that they could break the patent, using the march-in provision of the Bayh-Dole Act. So they could march in and say, "We did the research and development of this drug, and we want it to be available at this price."

We're asking them to do that. We're waiting for them to do that.

This transcript has been edited for clarity and brevity.

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