PrEP clinics brace for impact of Gilead decision

Gilead headquarters in Silicon Valley. (Photo credit: Sundry Photography -

The continued fight to end the HIV epidemic will likely hit another roadblock come January, when the pharmaceutical company Gilead plans to revise its pharmacy reimbursement model on HIV drugs that patients obtain through its Advancing Access Patient Assistance/Medication Assistance Program (PAP/MAP). 

Currently, HIV clinics that serve a high percentage of low-income or uninsured patients acquire PrEP at discounted prices and provide the drug to patients for free. Under Gilead’s current model, clinic pharmacies are reimbursed for the wholesale value of the prescription that they purchased at a much lower cost. 

Beginning January 1, 2022, the new PAP/MAP reimbursement plan will “[align] the amount reimbursed to the actual acquisition cost of the free product pharmacies are dispensing plus reimburses them a fair market value dispensing fee and administrative fee,” a Gilead spokesperson said in an email. “These changes protect the long-term sustainability of the program and stays true to its goals and principles – to provide free drugs to those in need – while ensuring that program participants and the pharmacies that dispense our free medication continue to bear no costs.”

Although some news outlets have been reporting that the reimbursement change will be happening as part of the 340B program, the Gilead spokesperson told PGN in an email that “Gilead’s provision of a free drug program is separate and distinct from our participation in the 340B program, which is unchanged by this update.”  

The impending changes to the PAP/MAP reimbursement program will likely have a negative financial impact on Philly’s HIV prevention and care systems, according to James Garrow, director of communications for the Philadelphia Department of Public Health. “340B discounts are a type of PAP/MAP,” Garrow added. “We maintain that the reductions to the PAP/MAP are resulting in reduced facility revenue.” He said that Gilead’s plan runs “directly in conflict with our work to end the HIV epidemic in Philadelphia.” 

Garrow explained that pharmaceutical reimbursement programs exist partly because “pharmaceutical companies have a business interest in as many people as possible being prescribed their brand-name medications while they have a patent.” He posits that the impending changes are due to one of the PrEP medications in the program becoming available in its generic form. The PrEP drug Truvada is currently available as a generic. 

Philadelphia’s AIDS Activities Coordinating Office will not be affected by the reimbursement cuts, though it will be indirectly impacted, “as organizations serving people living with and at risk for HIV lose revenue, leading to potentially fewer services available to Philadelphians living with and placed at risk of acquiring HIV,” according to Garrow.  

As of press time, it is unclear whether Mazzoni Center’s uninsured patients will be affected by the upcoming change, although most of the organization’s uninsured patients use Gilead’s PAP program “to obtain free medications directly,” Mazzoni Communications Director Larry Benjamin said in an email.  

Gilead’s PAP/MAP program was never intended to “fund ancillary services,” the company’s spokesperson said, and referred to HIV clinic use of reimbursement money as “unforeseen misuses of the program.” 

Nonetheless, HIV service organizations in the area could be significantly impacted by the reimbursement changes, Garrow said. He cited a report by Ryan White Clinics that indicates that HIV clinics could lose funds from 340B reimbursements in amounts of $18,000 per patient per year, numbers confirmed by Shannon Stephenson, president of the national advocacy group Ryan White Clinics for 340B Access and CEO of the Tennessee 340B-covered health organization Cempa Community Care. 

PrEP clinic staff can use those funds to foot the bill for programs that help patients navigate HIV treatment and prevention, ensure that patients stay on their HIV meds and help them regularly show up for checkups, Garrow said.    

“If other funding sources are not identified, staff and the services they provide could be reduced system-wide, potentially impacting HIV treatment and PrEP access, adherence, and retention,” Garrow said in an email. In other words, “people who need HIV treatment and prevention medications may have less help getting and staying on medications.”  

Black and Brown people are living with and contracting HIV at disproportionately high rates compared to their white cis counterparts. According to Philadelphia’s 2020 Ending the HIV Epidemic (EHE) Community Plan, in 2019, over one third of people diagnosed with HIV were Black men who have sex with men (MSM). The report estimates that in the same year, 1.6% of Black MSM, 1.3% of Hispanic/Latino MSM and 0.2% of white MSM who were previously HIV-negative were diagnosed with HIV.  

According to an NBC News article on the impact of the reimbursement cuts on PrEP clinics in the U.S., the use of PrEP has become dramatically more popular in the last handful of years. A report by the Centers for Disease Control and Prevention (CDC) indicates that PrEP is responsible for an 8% dip in HIV diagnoses from 2015-2019. A 2019 CDC report shows that smaller percentages of Black and Hispanic MSM either talked about PrEP with a healthcare provider or used PrEP in the past year compared to white MSM. 

“We recognize that there is an urgent need for funding to deliver critical HIV services and that free medication is only one component of the broader solutions needed to realistically maintain progress toward ending the HIV epidemic,” the Gilead spokesperson said in an email. “This is a systemic issue caused by gaps in federal and state prioritization of HIV care and prevention services – particularly in states that have not expanded Medicaid.” 

NBC News also reported that the federal EHE budget increased by $267 million in 2020, by $405 million in 2021, and the Biden administration is seeking to raise it to $670 million in 2022. 

On a local level, Garrow said that those funds are designated to be used for re-engagement programs for people living with HIV who have been lost to care; administering low-threshold HIV care at the syringe service program; augmenting access to priority populations in need of low-threshold sexual health services; expanding post exposure prophylaxis (PEP) and bolstering STD and PrEP services offered through the Philadelphia Health Department’s Health Center 1. Federal funds cannot be used to curb financial fallout from Gilead’s PAP/MAP reimbursement cuts, Garrow said.