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New Deal Makes PrEP Accessible for the Uninsured—But Will It Help: Public Health Watch

MAY 15, 2019 | BRIAN DUNLEAVY
These days, when a government official takes to Twitter, the world spins off its axis.

Or at least it seems that way.

However, a tweet posted on May 9th by US Department of Health and Human Services (HHS) Secretary Alex Azar has drawn all too little attention in the media. Indeed, Azar used the social media platform to announce that drug manufacturer Gilead Sciences had reached an agreement with the Trump administration to donate HIV pre-exposure prophylaxis (PrEP) medication for as many as 200,000 patients each year between now and 2030.

According to Azar, the drug supplies will be earmarked for those “who are at risk for HIV and who are uninsured,” particularly those residing in states and regions identified as “priority areas” as part of President Donald Trump’s plan (and goal) to end the epidemic in the US, as outlined in his State of the Union address in February. However, not everyone is so sure about the true merits of the deal.

“Under [President Trump’s] leadership, HHS worked with Gilead to secure preventative medication for uninsured individuals at risk for HIV who might otherwise not be able to access or afford this important treatment,” Azar tweeted. “The majority of Americans who are at risk and who could protect themselves with PrEP are still not receiving the medication. This agreement will help close that gap substantially…”

In an official announcement, HHS noted that, specifically, the agreement between the agency and the pharmaceutical company “will last until at least December 31, 2025, and possibly through December 31, 2030.” Under the pact, Gilead will provide supplies of the currently available PrEP regimen, marketed under the brand name Truvada, which carries a list price of more than $20,000 per patient per year, until its second-generation HIV preventive medication, Descovy, receives US Food and Drug Administration (FDA) approval for a PrEP indication. At that time, the company will donate Descovy until, perhaps, 2030, or when a generic version of the new regimen becomes commercially available, whichever comes first. In addition, HHS has agreed to cover costs associated with distributing the drugs.

But although all that sounds great on paper, the reality of the agreement, reportedly negotiated by Trump himself, remains unclear, particularly over the long-term. As documented recently by The Washington Post, PrEP has a somewhat convoluted and controversial history, and the US Justice Department is currently investigating whether Gilead actually owes the government back royalties on the patent for the regimen.

Moreover, as an editorial published on May 13th by The New York Times notes, Kaiser Family Foundation estimates suggest that only 20% of the more than 1 million Americans who could benefit from PrEP actually receive the regimen, and many of them already obtain it under the auspices of the Gilead Advancing Access program. Many individual states also offer at-risk patients financial assistance to enable them to start on PrEP, which, per HHS, has been shown to “reduce the risk of new infection by up to 97 percent when taken consistently.”

Unless the new arrangement will ultimately double the number of PrEP recipients, the Times argues, its effect may largely be redundant. According to the newspaper, the HHS/Gilead agreement doesn’t specifically address this issue.

Not surprisingly, as with anything political these days—particularly on social media—reaction to Azar’s announcement has been mixed. Carlos del Rio, MD, chair of Emory University’s Department of Global Health and co-director of the Center for AIDS Research, tweeted, “This is terrific! Thank you @SecAzar we really need to scale up #PrEP in the US if we are to [end the HIV epidemic].” His colleague at Emory, David Holland, MD, who calls himself a “sexual health advocate,” added, via Twitter, “I’m unclear how this is a significant improvement over the current medication assistance program, which is admittedly relatively generous and easy to access.”

Hopefully, we won’t have to rely on Twitter for news on the real impact of this development.
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