Gilead Sciences Proposes Change to Patient Assistance Program - April 2021
On April 8th, Gilead Sciences (Gilead) proposed a change to its Advancing Access Patient Assistance Program (PAP), which would require all PAP enrollees to receive their HIV medications (treatment and Pre-Exposure Prophylaxis (PrEP) through mail or courier delivery. Gilead’s PAP offers financial support for the uninsured, but this change—now slated to take effect in January 2022—poses significant challenges for what’s called 340B Covered Entities, including Ryan White clinics, Federally Qualified Health Centers (FQHCs) and rural and community FQHC look-alikes (FQHCLA) the most.
The change to the PAP could disrupt the way in which service organizations handle program income generated by PrEP and ongoing HIV treatment services to their uninsured patients—potentially creating many unintended barriers for at-risk individuals because of the reduced income.
While Gilead announced it wouldn’t be implementing the mandatory mail-order aspect of its PAP proposal after community push-back, it does underscore just how important local pharmacies and onsite navigators often play in service delivery in order to turn the tide of the epidemic, especially within hard-to-reach rural communities and minority groups—those most impacted by HIV.
Section 340B of the Public Health Service Act requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low-income patients. In short, 340B contract pharmacies (through the Health Resources & Services Administration, which oversees Ryan White HIV service programs) typically provide patients with supportive service health care navigation education, support, referrals, and information about their condition, and they are often housed in clinics closely associated with other HIV service organizations.
Relationships like that, where Ryan White service providers or community health clinics, as part of their scopes of federal HIV community services work, enter into contractual relationships with outside pharmacies are integral to the federal End the HIV Epidemic (EtHE) work. And covered entities depend on locally-generated program savings through the 340b rebates program to support their patient navigation work—often using that income to offset ancillary PrEP costs like labs, co-pays, and insurance premiums, as well as a whole host of other navigation work. Some even use that income to build their own onsite pharmacy.
In fact, many health centers took on federal Ryan White service contracts after the implementation of the ACA, in order to offer just those type of necessary supportive services to their patients most impacted by health disparities and inequities.
From a real high level point of view, pharmacies negotiate with drug wholesalers to purchase HIV medications. In turn, the 340B covered entities are allowed to keep the difference between the pharmacy and wholesale price, thus accumulating rebate dollars that can be generated back to the agencies.
Should the proposed change to the PAP occur, 340B covered entities won’t be able to collect rebate dollars for HIV treatment or prevention services (as part of PrEP and PEP, or Post-Exposure). The changes could diminish saving for 340B by upwards of $1,260 per bottle of Gilead’s PrEP pill, Truvada—among others. This equates to a decrease in savings of $15,000 per patient annually. In total, this change would amount to over a $100 million loss in HIV service funding across the United States to uninsured patients. 340B entities could find it difficult to offer important those vital supportive services, including ancillary cost-savings, such as HIV PrEP insurance navigation work, copay assistance, and transportation, as well as patient outreach, patient education, health insurance, and testing and treatment for sexually transmitted infections.
Some of the 340B covered entities are community health clinics, which offer many of the services mentioned above. These clinics generally serve those at disproportionate risk for acquiring HIV, including Black and Brown, Indigenous and other People of Color (BIPOC). By instituting this proposal, 340B covered entities will have a hard time making up for this lack of funding, rendering them less relevant. As a result, covered entities may provide their uninsured patients reduced services, increasing the likelihood of HIV transmission among vulnerable communities.