When President Biden released his 2023 budget request, he generated excitement among national HIV/AIDS advocates by proposing a 10-year $9.8 billion investment in a national pre-exposure prophylaxis (PrEP) program for uninsured Americans. The scale of the funding is reminiscent of the Ryan White HIV/AIDS Program that has done so much for treatment access for people living with HIV in the United States. Given recent analyses demonstrating that improved coverage for PrEP medication and labs via special state programs or Medicaid expansion translates into significant increases in uptake, there is much to celebrate in the announcement.
But for those of us who have worked for a decade to increase PrEP access for Black, Latinx, transgender, and gender diverse people, the key question is: Will this program, should it make it through significant congressional hurdles, really translate into access for those who need PrEP the most?
The proposed program as it stands in the budget has relatively few specifics (see page 191 of the HHS operating plan) although it appears to draw significantly from a white paper published in December 2021 by a team out of Johns Hopkins University (JHU).
One of the stated goals of this proposal is to advance equity; however, good intentions and thoughtful design do not always translate into equitable implementation. For this reason, the JHU team reached out to several stakeholders with expertise in equitable PrEP access to coauthor a series of articles to be included in a forthcoming special edition of the Journal of Law, Medicine, and Ethics. Given the early momentum for a national PrEP program we — as authors of two key articles on equity in PrEP access — are releasing our contributions to the edition ahead of print. We and the JHU team have done so with at least two objectives: 1. To ensure that health systems policy-speak does not eclipse requests from advocates for a well-rounded national program that centers the needs of Black, Latinx, and transgender and gender diverse people. 2. To call for a transparent and participatory approach to advocacy going forward, particularly as national advocates prepare a national legislative strategy for the program.
Equity and the Price of PrEP
One thing is clear with the funding in the national PrEP proposal; the less we are forced to spend on medications, the more we can spend on key ancillary services, an expanded provider network, demand creation, provider education, and everything else our communities need to truly access PrEP. For this reason, much of the JHU proposal focuses on getting medication costs down. While we will need to do better to outline a budget that meaningfully invests remaining resources in communities of color, women, and transgender and gender diverse individuals; this is a necessary first step to maximize our resources.
Kenyon Farrow takes the link between price and equity even further in The Downstream Impacts of High Drug Costs for PrEP Have Hindered the Promise of HIV Prevention. Farrow argues that even with copay cards and patient assistance programs, high PrEP costs have severely limited potential uptake since PrEP was approved in 2012.
“[H]igh drug list prices for antiretroviral medications including those used for prevention, still impact access to these drugs downstream, even when the patient has low or no out of pocket costs. And while patient assistance programs can help cover some of those out-of-pocket costs for people who are not insured or cannot afford the prescription co-pays, they have not been enough to increase equitable access. The high list prices of the initial brand name drugs for PrEP have dictated PrEP delivery systems in the U.S., including how PrEP was marketed, clinical guidelines to determine PrEP eligibility, and prior authorization requirements from payers.”
Farrow goes on to hypothesize that high cost may also have limited the populations addressed by PrEP campaigns. “[O]ne question that should be explored by historians, bioethicists and other social scientists is whether or not the decision to nearly exclusively market PrEP to gay and bisexual men (until there was pushback from cisgender women and transgender activists) was at least in part due to the cost of the medication itself. Or were the very complicated sexual risk assessments in the early clinical guidelines that made it so that many Black and Brown men and women were missed as not having enough risk factors was either consciously or unconsciously written knowing a broader population of PrEP users would stretch already grossly underfunded city, county and state HIV/STD public health programs.”
Building Equity into a National PrEP Program
Another piece being released early comes from Jeremiah Johnson, Asa Radix, MD, PhD, Raniyah Copeland, and Guillermo Chacon. In Building Racial and Gender Equity into a National PrEP Access Program, the authors walk us through the unique access challenges facing transgender, gender diverse, Black, and Latinx communities. At the end, the authors highlight seven themes that must be addressed by a national PrEP program:
- Intentionality: a program must be designed specifically with racial, ethnic and gender equity in mind. Federal, state, and local implementers should continually consider if vulnerable Black, Latinx, transgender, and gender diverse communities are likely to benefit in rural, suburban, and urban contexts.
- Financial transparency and accountability: program budgets should transparently account for the costs of a national PrEP program in a way that demonstrates that the intersectional needs of communities that need PrEP the most are being identified and properly resourced.
- Representation matters: PrEP programs designed by and for the communities they aim to serve have been shown to be highly effective. In order to be strategic, any federal and health department leadership for a PrEP access program must reflect racially, ethnically and gender diverse communities. An expanded provider network must be shown to increase the number of Black, Latinx, and transgender providers offering services.
- Effective community outreach: innovative messaging approaches must be pursued as knowledge of PrEP has not fully permeated vulnerable communities. Messages by and for current and potential PrEP users from priority populations will help reflect the key messages and address any linguistic barriers that prevent uptake of key information.
- Effective provider education: In addition to receiving basic clinical guidance, any extended provider network established through a national PrEP access program must be effectively educated on unique barriers to uptake and access for Black, Latinx, and transgender populations.
- Socioeconomic factors: PrEP access must be specifically paired with services that help to combat socioeconomic risk factors for vulnerable populations such as low income, unstable housing, and unsafe living environments. This should be considered in recruitment of a provider network, with specific emphasis on organizations that focus on these overlapping services across several geographic settings.
- Ongoing research: Implementation of a federally coordinated access program should partner with NIH to study the effectiveness of scale up for Black, Hispanic/Latinx, and transgender populations, any persistent barriers to uptake, and potential extrapolation to other hard to access preventive healthcare services (e.g. Narcan). Implementation science must be prioritized to ensure we are documenting the successes and challenges of such a program.
Calling for an Equitable Advocacy Process
The articles — along with the JHU proposal and the language in the President’s budget — are just the start of a discussion that will require many national policy experts to ensure a legislative and programmatic strategy that truly centers racial and gender equity. Building on months of discussions, PrEP4All and the JHU team are coordinating an advocacy process emphasizing transparency and multi-stakeholder participation. As national advocates gear up to help with the heavy congressional lift ahead of us, we call for these existing documents and an open sign on letter authored by the coalition to form the foundation — but not the ceiling — for a strategy. We also call for national advocates to enthusiastically join this ongoing dialog on a national legislative strategy. To achieve equity, we must demonstrate equity; coming together to allow the best ideas and evidence to inform our way forward, ensuring that our work has a realistic chance of getting PrEP to those who need it the most.
Jeremiah Johnson, Kenyon Farrow, Raniyah Copeland, and Asa Radix, MD, PhD, are longtime HIV/AIDS advocates.