PrEP Could Reduce HIV Infection Rates. So Why Isn't It Cheaper?

HIV/AIDS activists believe a blue pill could effectively stop new infections in the United States. But without insurance, it can cost well north of one thousand dollars per month.

The pill is PrEP, or pre-exposure prophylaxis, a daily medication that cuts the risk of getting HIV from sexual intercourse by over 90 percent and that lowers the risk of getting HIV from injectable drug use by over 70 percent, according to the Centers for Disease Control and Prevention.

In the United States, there is just one brand of PrEP available: Truvada, made by pharmaceutical company Gilead Sciences.

This week, HIV/AIDS activists are putting pressure on both Gilead and the federal government to put PrEP within reach of more people who can’t afford it.

Prep4All advocates James Krellenstein, Aaron Lord, and Peter Staley penned a New York Times op-ed on Monday pointing out that the combination of PrEP with modern HIV treatments that make the virus untransmittible could spell “a swift end to the epidemic” were it not for the high cost of Truvada in the United States.

“In other countries, a one-month supply of generic Truvada costs less than $6, but Gilead charges Americans, on average, more than $1600, a markup from the generic of 25,000 percent,” they wrote.

As NewNowNext reported, groups and campaigns like ACT UP New York and Prep4All’s are protesting this week to urge the National Institutes of Health to terminate Gilead’s patent on Truvada, effectively opening up the generic market for PrEP in the United States.

“The NIH could ‘march-in’ and break the patents around the drug at any time, immediately lowering the price and allowing millions to gain access to this life-saving treatment,” the website notes.

In response to questions about protests around the high cost and patented status of PrEP, Gilead Sciences issued a lengthy statement to The Daily Beast, directing “anyone facing financial difficulties” to a website for financial and insurance support.

“Gilead is committed to ensuring that people who are at high risk for HIV infection have access to Truvada for PrEP,” the statement began. “We support comprehensive payer coverage, and maintain support programs for qualified and underinsured people in the United States who cannot afford their medications. This includes our co-pay coupon program and the medication assistance program.”

LGBT advocates, however, say that the existence of financial assistance programs are no substitute for a simple, low-cost form of PrEP.

“The idea that this is a sufficient solution is patently false, and Gilead has been provided over and over again with evidence of it, and instead of actually dealing with the problem, they continue to endanger our community for their own insatiable greed,” Krellenstein, a founding member of Prep4All and one of the authors of the New York Times op-ed, told The Daily Beast.

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Gilead’s statement also made note of the millions the company spends on PrEP community grants and education initiatives to help overcome what they call “one of the greatest barriers to Truvada for PrEP access today,” namely “limited awareness” of the drug’s “role in HIV prevention.”

A lack of education around PrEP is indeed a pressing problem. One 2017 survey of primary-care physicians found that 93 percent of respondents had heard of PrEP but only about a third had adopted it into their practice, due in part to misconceptions about its safety and effects on sexual behavior.

As recently reported, research suggests that public awareness of PrEP is increasing, but significant racial disparities remain, as well as disparities between people living in urban areas and those in rural areas, with just two percent of rural gay and bisexual male respondents to one survey reporting that they used the drug.

But while no one would dispute the value of educational initiatives around PrEP use, the markup on Truvada itself remains a sticking point.

“It is difficult to credit the beneficence of a company that marks up the price of a medication 250 times what it costs to make, particularly when it is the only such medication approved for the prevention of an epidemic infectious disease,” wrote Daniel Summers at Slate.

Adding to the anger over the price of Truvada is the fact that it was created in large part as a result of public funding.

Krellenstein, Lord, and Staley noted in their op-ed that “American taxpayers and private charities—not Gilead—paid for almost all of the clinical research used to develop Truvada”—and, indeed, Summers reported that NIH research and public money played a sizable role in the development of Truvada for PrEP.

That history of taxpayer funding has only heightened calls for NIH to break the patent on PrEP. But such calls seem unlikely to lead to action from the federal agency. As STAT News reported, the NIH has so far not taken action to lower the cost of licensed drugs that were researched with public money—despite many calls to do so in recent years.

Advocates point to the 1980 Bayh-Dole Act, which gives the government “march-in rights” to break up a patent such as the one on Truvada if “action is necessary to alleviate health or safety needs which are not reasonably satisfied” by the patent holder. So far, though, the NIH has never “marched in.”

But if NIH were ever going to do so, HIV/AIDS advocates say now is the time.

“We think that we have a unique use case that the Bayh-Dole statute was created for,” Krellenstein told The Daily Beast. “HIV is a public health crisis in this country. We know that if we could scale up Truvada to all the people who need it in the United States, we could see a dramatic reduction in the number of new HIV infections.”

Indeed, Krellenstein sees this as a test case for the Bayh-Dole language itself: “If they are not going to march-in on this drug, what drug would they possibly do it on?”

Urging NIH action may be the only route HIV/AIDS advocates feel like they can take in the current environment. Gilead’s statement to The Daily Beast did not indicate that the company is planning to lower the cost of Truvada.

“Data from our patient support programs do not suggest that cost is a primary obstacle to treatment,” the statement said. “The majority of people receiving Truvada for PrEP today who utilize our co-pay coupons pay less than $5 per bottle, and our co-pay assistance program is sufficient to meet the needs of the large majority of people who use it.”

But with Gallup data showing that LGBT Americans more likely to be uninsured than non-LGBT Americans, the reach of co-pay assistance programs only extends so far.

For uninsured people, receiving financial help for Truvada requires extra steps, including proof that your income is low enough to qualify for aid.

The Gilead Advancing Access website instructs uninsured patients to call a counselor on weekdays, or fill out a nine-section enrollment form to determine eligibility for financial assistance.

The CDC website notes that “the cost of PrEP is covered by many health insurance plans”—and otherwise directs prospective PrEP users to the Gilead hotline.

But even PrEP users with health insurance can face challenges because, as Healthline recently reported, some insurers are rejecting co-pay coupons from drug manufacturers, transferring out-of-pocket costs back down to patients and effectively putting costly drugs like Truvada out of reach. Gilead’s co-pay coupon program also has an annual cap—$4,800 per Slate’s reporting—that may not fully cover annual out-of-pocket costs.

“I literally know people who have seroconverted—who have become HIV-positive—because they hit the maximum amount on the co-pay assistance program, they couldn’t afford the gaps in between that [assistance], and then they couldn’t access Truvada and weren’t protected from HIV,” Krellenstein told The Daily Beast.

Tom Blake, who does communications for PrEP4All, says that because wealthy, insured people at risk for HIV—“predominantly white gay men living in major cities”— are able to get PrEP for virtually nothing, the ci-pay coupon program is “really effective at muddying the waters” of the conversation around the price tag of Truvada.

“It removes a potential constituency of dissent from Gilead’s pricing issue,” he told The Daily Beast. “It allows them to complicate the conversation around the pricing issue since most people are not seeing the cost at the time they’re picking up the medication.”

HIV/AIDS advocates argue that the sticker price of the drug clearly matters, pointing to a prominent international example of a free PrEP program for proof.

A recent trial in New South Wales, Australia, with results reported at the Conference on Retroviruses and Opportunistic Infections, found that recruiting high-risk men who have sex with men—or MSM—into a PrEP program coincided with a “35 percent decline in state-wide HIV diagnoses in MSM, and a 44 percent decline in early HIV infections in MSM, to levels unprecedented since the beginning of the HIV epidemic.”

“The price of Truvada and the behavior of Gilead in blocking generics coming to market is disgusting. What I would like to see happen is the patent broken”

In their New York Times op-ed, Krellenstein, Lord, and Staley called this “one of the fastest declines recorded since the global AIDS crisis began,” highlighting the fact that the program provided “free access to PrEP.”

Greg Owen, co-founder of the United Kingdom charity iwantPrEPnow, which operates a website directing users to merchants that sell generic PrEP, told The Daily Beast that about 5 percent of web traffic this year—roughly 20 thousand users—has come from the U.S.

“The price of Truvada and the behavior of Gilead in blocking generics coming to market is disgusting,” Owen told The Daily Beast. “What I would like to see happen is the patent broken.”

Owen started iwantPrEPnow in response to barriers to access in the United Kingdom, particularly in England where PrEP access is limited to those involved in a National Health Service trial. But has linked out to iwantPrEPnow on their own website — while warning that importing the drugs is “technically illegal.”

Amid all of the controversy around the price of Truvada, HIV/AIDS advocates are also battling concerns that widespread use of PrEP will lead to increases in other sexually transmitted infections.

If PrEP use lowers risk of HIV infection, the logic goes, some at-risk people may feel emboldened to engage in riskier, condomless forms of sexual activity—a behavior known as “risk compensation.” (The CDC is very clear that “you should not stop using condoms because you are taking PrEP,” warning that it “doesn’t give you any protection against other STDs, like gonorrhea and chlamydia.”)

Research on risk compensation is still early, with some studies showing that PrEP use increases rates of other STIs and others, like a 2017 study in the journal AIDS, warning that “exaggerated and incorrect data on negative potential outcomes of PrEP use may discourage PrEP’s consideration as an HIV prevention strategy.”

Patrick William Kelly’s June New York Times op-ed entitled “The End of Safe Gay Sex?” was criticized by HIV/AIDS activists precisely along these lines because of its stern warning about decreasing condom use, and its assertion of a “strong correlation between PrEP use and the contraction of STIs.” (Two paragraphs later, Kelly qualified between parentheses that “other studies have found no significant uptick in STI rates.”)

The truth of the matter is likely complex: PrEP use is not the only factor that makes men likelier to engage in risky sexual activity and, for some users, the regular check-ins that PrEP requires may actually help lower risk of some STIs.

“Frequent screening—a required component of PrEP care—could decrease rates of other sexually transmitted infections through prompt treatment, even if rates of condom use decrease,” Krellenstein, Lord, and Staley argued.

One 2018 study, published in the British Medical Journal, of men who accessed PrEP through the Los Angeles LGBT Center found that “risk compensation appears to be present for a segment of PrEP users, the majority of individuals either maintain or decrease their sexual risk following PrEP initiation.”

Another widely-cited 2015 study found that, “Those who felt their risk behaviors may increase as a result of PrEP were overwhelmingly those who were already engaging in some degree of HIV transmission risk behavior.”

“If people use PrEP inconsistently and end up seroconverting, they will get diagnosed early and be able to get in treatment and virally suppressed quickly”

Aaron Lord, an NYU physician and one of the co-authors of the recent New York Times op-ed about the price of Truvada, told The Daily Beast that PrEP will not only get more gay and bisexual men plugged into the healthcare system, it will also help prevent those who don’t know they already have HIV from spreading it.

“The main argument against fears of declining condom use is that the most deadly STI we have, HIV, is prevented with PrEP,” Lord said. “Connecting people with care will not only lead to increased testing for other STIs, but if people use PrEP inconsistently and end up seroconverting, they will get diagnosed early and be able to get in treatment and virally suppressed quickly.”

Lord is well aware that the NIH has never granted a Bayh-Dole drug price petition—but he thinks that there’s a first time for everything.

“We believe PrEP is a unique opportunity since it is a primary prevention tool,” he said. “[It] needs to be cheap and easily accessible.”

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