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For the past week, accolades and excitement have permeated the HIV advocacy space. The reaction is due to the March 28 release of the Biden Administration’s proposed Fiscal Year 2023 (FY23) budget, epilepsy lamictal which seeks Congressional approval for increasing funding toward its Ending the HIV Epidemic in the U.S. But the budget also allocates a mandatory,10-year, $9.8 billion investment in prevention efforts geared toward providing broader preexposure prophylaxis (PrEP) access, an action that is deemed essential for reducing new HIV infections by at least 90% in less than 8 years.

But it raises the question; aside from Congressional approval, what will it take to really move the envelope out of the research lab and into communities most at risk?

“The science with PrEP keeps getting better and better…it really works at both the individual level to reduce risk if taken as prescribed…and at the public health level,” Chris Beyrer, MD, MPH, Desmond M. Tutu Professor of Public Health and Human Rights, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, told Medscape Medical News.

“But the way that our health system works and the way that it’s failing to deliver, particularly to low-income working people and the uninsured, we actually have a widening of health disparity going in the wrong direction,” he added.

The statistics do indeed paint a stark picture. 

Despite the 2012 FDA approval of tenofovir disoproxil fumarate with emtricitabine for PrEP, uptake in the United States has at best been spotty. At last estimate (2020), fewer than 25% of people eligible for PrEP actually received a prescription, and according to the Centers for Disease Control and Prevention, most of them were White. In comparison, only 9% of African Americans and 16% of Hispanics/Latinos who were eligible for PrEP received a prescription. 

The PrEP landscape is also marred by notable and growing disparities by gender (for example, preliminary 2021 data show that only 10% of women eligible for PrEP received a prescription in 2020) and gender identity (eg, among transgender women, 92% are aware of PrEP but usage lags far behind, at 32%).

“This is a systems problem and we really need a rethink,” Beyrer said.

A Blueprint for a National Program

Along with outside consultants, Beyrer and his colleagues at Johns Hopkins have developed a proposed framework for a national PrEP program that emphasizes the need for “a functioning safety net system for PrEP access.” The proposal is geared toward overcoming existing fragmentations inherent to current manufacturer and federal programs that are mostly geared toward providing antiretroviral therapy. And if those programs do offer PrEP, they tend to be focused on costly, brand-name drugs.

“The programs are onerous and complicated, don’t cover labs (which is a big barrier for low-income people), and essentially make [access] impossible for uninsured people,” explained Beyrer. “It hasn’t changed the game at all.”

To address these concerns, the proposed framework offers a three-pronged strategy:

  • Streamline access to PrEP medications through direct federal purchase of generic PrEP medications and laboratory services, secure public health pricing, and guarantee availability for uninsured and Medicaid recipients without a copay 

  • Enhance clinical care by 1) enabling PrEP access via on-site, clinic-based dispensing that promotes same-day starts, and 2) creating a “laboratory network of last resort” for indigent patients that also facilitates data integration

  • Create a national network of PrEP access points supported by telehealth, eg, domestic violence centers, pharmacies, and street outreach programs that circumvent traditional avenues of prescribing practices and “meet people (especially those who do not regularly access clinical health services) where they are”

Beyer pointed to countries like the United Kingdom, France, and Australia, that, in recent years, have scaled up national PrEP access and have seen significant declines in incidence and new infections. But these programs are not without their own growing pains. For example, findings from a qualitative study published March 1, 2021, in Sexual Health highlight multiple, clinician-specific challenges such as discomfort with and confusion over on-demand PrEP or clinic access by the uninsured. On-demand PrEP issues have also been reported by UK practitioners — lessons that policy makers might wish to pay attention to. 

In addition, if the onerous effort required for passing the Affordable Care Act offers any lesson, it’s that the path for expanding coverage (in this case, for PrEP) is one that is likely to be bumpy — an important consideration raised by Jeffrey S. Crowley, MPH, program director of Infectious Disease Initiatives at Georgetown University’s O’Neill Institute for National and Global Health Law, and former director of the White House Office of National AIDS Policy, when asked about the Administration’s proposed budget and Hopkins’ program strategy. 

“It talks about a new program but also states that it wants to build on the work in tandem with existing PrEP funding and programs,” Crowley told Medscape Medical News

“I think that getting that right is going to be important,” he said.  

Crowley also emphasized that any national PrEP program will need to systematically overcome the weak public health infrastructure in the states themselves and use federal levers to encourage states to foster strong partnerships with grassroots organizations, community providers, and trusted allies that consider HIV prevention a priority.

There’s no doubt that getting a national PrEP program budget through Congress is going to entail a lot of legislative wrangling and a lot of work — work that will likely not be completed by 2030. 

“When I was President Obama’s HIV/AIDS advisor and we released the first national HIV/AIDS strategy, we set metrics but were very transparent with people,” Crowley noted. “Our guiding star is that we need to enact a program and need it to really get our country on track toward ending the HIV epidemic.”

Beyrer reports no relevant financial relationships. Crowley reports receiving funding from Gilead, Merck, and Viiv.

Liz Scherer is an independent journalist specializing in infectious and emerging diseases, cannabinoid therapeutics, neurology, oncology, and women’s health.

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