In June, a clinical trial showed that a twice-yearly injection was just as effective at preventing HIV as the daily oral medication. The trial was so successful that the Data Monitoring Committee instructed researchers to halt the study and immediately offer the injection to all study participants.
This is just the most recent development in longer-acting HIV medications, which have become a transformative force in the journey toward ending the HIV/AIDS crisis. Currently, the long-acting products on the market are delivered via intramuscular shot every two months. They reduce pill burden, thus enhancing adherence, while also minimizing the stigma often associated with daily medication. An every-six-months injection would make an even bigger difference.
Yet, despite their game-changing promise, these innovations will only fulfill their potential if Medicaid — the largest source of HIV care financing in the United States — takes decisive action to ensure that they are accessible to the populations that need them most.
Medicaid currently provides care for 40% of adults under 65 living with HIV, making it a cornerstone in efforts to combat the epidemic. The people vulnerable to poverty who are served by Medicaid — particularly LGBTQ+ communities and communities of color — are also those most deeply affected by HIV. Yet, these same communities often face systemic barriers to accessing the care they need, from housing instability, food insecurity and lack of transportation to lack of culturally and linguistically competent health services and outright discrimination within the health care system.
Pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) are generally covered by state Medicaid, though coverage varies from state to state. Some states do not even pay for the necessary routine labs and STI testing.
Widespread availability of longer-acting HIV products in the United States may still be years away, but as the current state of affairs shows, if we wait until then to address Medicaid accessibility it will be too late. That’s why Cicatelli Associates’ TAP-in project and our organizations — Georgetown Law’s O’Neill Institute for National and Global Health Law and Amida Care — recently convened approximately 40 HIV experts from across the United States to discuss the best way to ensure that Medicaid-eligible Americans have access to these products as soon as possible.
Based on those discussions, here’s what needs to happen.
At the federal level, the Centers for Medicare & Medicaid Services should update the 2016 Informational Bulletin on HIV prevention and care delivery to reflect the latest advancements in longer-acting therapies. CMS also should issue specific policy guidance on Medicaid’s role in supporting the uptake and persistence of PrEP to prevent new HIV cases. Additionally, CMS must designate an official within the administrator’s office to coordinate HIV policy and enhance collaboration across federal agencies.
These programs also have a critical role to play to ensure that managed care contracts support the implementation of longer-acting treatments. Furthermore, state Medicaid programs should ensure that beneficiaries have consistent access to all covered antiretroviral medications across health plans, regardless of the delivery system. This maximizes the state’s ability to be transparent and consistent when acquiring rebates to make these medications more affordable and cost-effective.
Addressing disparities in PrEP use is imperative. PrEP has been available for more than a decade and is highly effective in preventing HIV, yet uptake remains lower among those covered by Medicaid compared with those with private insurance. Between 2012 and 2018, those with commercial insurance initiated PrEP at seven times the rate of those with Medicaid. Systemic barriers continue to disproportionately hurt people from Black, Latine, and transgender communities, who are more likely to be eligible for Medicaid. The introduction of longer-acting PrEP formulations presents a unique opportunity to close this gap, but only if Medicaid leaders at both the federal and state levels make the necessary changes to ensure appropriate access.
Longer-acting HIV treatments offer the potential to rectify established inequities in both prevention and treatment. By reducing the burden of daily medication and associated stigma, these products can make a significant difference in the lives of people living with HIV. But to move from regimens that are available via pharmacy pick-ups to those that may require office visits and provider administration will necessitate a greater understanding of coverage requirements, beneficiary protections, and the utmost flexibility in state Medicaid programs.
Medicaid has long been at the forefront of the fight against HIV, but to truly make a difference, it must now lead the charge in integrating these longer-acting products into care. We cannot afford to miss this opportunity.
Doug Wirth is the CEO of Amida Care, a Medicaid Special Needs Health Plan. Jeffrey S. Crowley is the director of the O’Neill Institute’s Center for HIV and Infectious Disease Policy at Georgetown Law.
