If Nobody Slashes the Price of Truvada for PrEP, What Happens Next?

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Demetre Daskalakis, M.D., the openly gay HIV/AIDS and sexual health czar for New York City's health department, likes to dream aloud about what a radically cheaper Truvada (FTC/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) could mean for ending the HIV/AIDS epidemic -- not just for New York City and the rest of the state, but for the country.

"If you could get the drug price lowered, that would be a fabulous way to put your federally qualified health centers at the heart of ETE [ending the epidemic] efforts to support the care and visits, while the drug becomes inexpensive enough that everyone can access it," he mused. Federally qualified health centers are community-based clinics nationwide that get federal funding and often serve people with no other health coverage, including undocumented immigrants. Many have called for Truvada-maker Gilead Sciences to reduce its current monthly $1,600 PrEP price tag to $50 a month.

Daskalakis called New York a "wonderland" in terms of the multiple ways it devised to theoretically get PrEP to everyone in the state who needs and wants it, but lamented the obstacles faced by non-rich people with high-copay insurance plans in other states, including southern and midwestern states whose governments have not chosen to expand their Medicaid programs. For them, Gilead's PrEP copay assistance program only goes so far, suddenly leaving them with huge costs once they max out their benefits -- and often forcing them to go off PrEP altogether.

The Centers for Disease Control and Prevention (CDC) reported recently that a majority of gay and bisexual men at risk of HIV in the U.S. were still not on PrEP, especially men of color at highest risk, even though most of them knew about the regimen.

"If the price of PrEP were lowered," said Daskalakis, "we'd be able to cover lots more people in that middle range who aren't adequately insured. It's just a public health truth that the price needs to be lowered to increase accessibility."

A Critical Point in Truvada Pricing

Could we be on the brink of that price reduction? And what happens if we're not? It's a critical question to ask at this moment: In early April, Trump's health secretary Alex Azar told NPR, "We are actually in active negotiations and discussion with Gilead right now on how we can make PrEP more available and more cost effective."

This remark came on the heels of a March 26 Washington Post story clarifying that the CDC actually holds patents on Truvada as PrEP, which was developed with taxpayer money, but had not enforced those patents in the U.S. on Gilead. The CDC had in fact enforced the patent in other countries, where Truvada is available for as little as $6 a month.

Much of the work leading up to the revelation had been done by the activist collective PrEP4All.

The revelation led many to wonder if the federal government, as part of its recent Trump-announced effort to end the HIV/AIDS epidemic, would actually use the leverage of its Truvada patents to force Gilead to work out a price reduction on the drug, which also might include a settlement that would make Gilead direct some of the billions it has made off of Truvada into programs expanding PrEP access nationwide.

Certainly, the government knows that activists and even providers are outraged over the CDC not having enforced the patents. At the AIDSWatch advocacy conference in early April, CDC director Robert Redfield, M.D., was heckled several times by HIV community members, including PrEP4All's James Krellenstein and Nick Faust, over the issue.

And at the recent National HIV Prevention Conference, longtime HIV provider Michael Saag, M.D., of Alabama took the rare step, for a provider, of devoting all his time in a plenary session to calling out the current high price of Truvada.

"In the USA, it's $1,667, with currently no generic [available]," he said. "If I go to Canada, it's $821, or $100 for a generic of the same product. If I go to sub-Saharan Africa, it's $5 a month. If you can make this product and be somewhat profitable at $5 a month, what are the profits at $1,667?" The comparison was met by applause.

Queried by TheBody as to when, if it all, the government would reveal the results of its supposed talks with Gilead, media reps at the CDC referred TheBody to their counterparts at the Department of Health and Human Services, who in turn referred TheBody to Secretary Azar's remarks on NPR -- and would say no more.

Further Measures to Lower PrEP's Cost

Which begs the question: If nothing comes out of the talks, what are the next steps?

One would be demanding pressure from Congress, says Krellenstein, adding that PrEP4All is already in meetings with members of various congressional committees.

"If CDC is not going to involve the community in these decisions, we're going to talk to Congress about demanding answers from them and from Gilead," he says. "These CDC patents provide a way for CDC to reduce the price of Truvada -- but they also provide a funding stream for a universal PrEP access program. CDC needs to take an active role in making that a reality. There are billions of dollars in damages here that the CDC can claim from Gilead."

PrEP4All has started a sign-on petition called #BreakThePatent, even if what the group is really asking for is that the CDC enforce its own Truvada patents against Gilead to make the drugmaker bring prices down.

Krellenstein also says that more street-level (or, in the case of indoor conferences, floor-level) protests are also likely if the government and Gilead do not soon announce price reductions. "There are definitely going to be actions," he says.

Saag, for his part, says that if the current talks supposedly underway between both entities don't yield results, he's ready to rally other HIV care providers to the cause. He says he'll even go as far as starting a movement to get providers to prescribe generic Epivir (lamivudine, 3TC) and Viread (tenofovir disoproxil fumarate, TDF) -- which are very similar to the components of Truvada -- instead of Truvada itself, an idea he floated at the prevention conference in March.

Yes, he acknowledges, that would mean patients would have to take two pills daily instead of one -- and, yes, the two pills have not been tested against Truvada for efficacy. "But I don't think we need [the testing]," he says, because we know both that TDF alone reduces infection risk and that multiple studies have shown that 3TC and FTC are equivalent at suppressing HIV.

A Bigger Issue: How Drug Prices Are Set in the U.S.

Of course, nobody is saying that Truvada is the only drug priced outrageously high in the U.S. compared to other countries. "It's all drugs," says Daskalakis, "but PrEP is a great example of [the failure of copay assistance programs], where people are good to go for a few months [until the programs max out], then, boom! It's over."

And Saag is not the first to recommend that the government, alongside standard Food and Drug Administration (FDA) review of efficacy and safety, also have an independent board, akin to Canada's Patented Medicine Prices Review Board, that would demand transparency and set parameters on pricing of new drugs.

"The company would present their case for what they think the pricing should be, and this board would make a decision for what the U.S. government would pay, and that price would be published in the public domain," Saag proposes. "No more cloaking and secrecy."

But for now, the focus remains firmly on Truvada. "It's a fiction that it's already available to every single person who needs it," Krellenstein says of Gilead's claims that its patient assistance program (PAP) takes the bite out of the drug's underlying high price. "The PAP doesn't work for anyone on Medicare Part D, which covers a fraction of the price. Yes, Medicaid covers it, but a lot of people can't access Medicaid, especially in the American South." He also echoes Daskalakis's points about Gilead copay assistance on private plans helping patients only to a point.

"In Australia," Krellenstein says, "when they had access to generic PrEP and made it universally accessible, they reduced the number of new HIV infections in the most vulnerable communities by a third in one year."

By contrast, he says, in the U.S., since PrEP was FDA-approved in 2012, HIV rates have gone down among white gay and bisexual men but have flatlined among black gay and bisexual men and have been rising among Latino gay and bisexual men.

"In the sum total," he says, "we have literally the same number of people infected today as we did before PrEP." And that, he says, is unacceptable.