Drug manufacturer Gilead has altered a planned change to its patient assistance program (PAP) for uninsured people living with HIV that would have been unworkable for some vulnerable patients, HIV/AIDS caregivers and activists say. The change also would have deprived 340B covered entities of savings on Gilead HIV products that help fund wrap-around services for these patients, they say.
In recent days, sources told 340B Report that Gilead would announce this week that uninsured patients who get free HIV treatment and prevention medicines through Gilead’s Advancing Access PAP would have to begin getting the drugs only by direct delivery from a single Gilead-designated specialty pharmacy. The change was expected to start in April.
Health care providers who specialize in treating patients with HIV and sexually transmitted infections (STIs) say that having to get HIV medications exclusively via courier is not viable for people with housing instability; anyone with confidentiality concerns; and people with substance use disorders or mental health problems.
Currently, uninsured patients enrolled in Gilead’s PAP can fill their prescriptions for free HIV drugs at 340B covered entity in-house or contract pharmacies. These entities buy Gilead HIV products at 340B price, then bill Gilead (using Rx BIN, PCN, and Group ID numbers provided by the PAP) at higher usual and customary rates.
340B covered entities’ savings under this under this system would have ended. NASTAD, the association of state HIV public health officials, told its members in a Jan. 14 email it “believes the potential revenue loss will be considerable, including for many health department HIV prevention and STI programs.” Providers say they use 340B revenues help pay for vital services including testing, education, transportation, and mobile health clinics for people living with HIV.
NASTAD and others in the HIV community said they raised their concerns with Gilead, and company appears to have listened.
Gilead confirmed in an email to 340B Report yesterday that it “is now offering the option for eligible uninsured patients to receive their free HIV medicine via direct delivery” through Gilead’s Advancing Access PAP. “We are working closely with the HIV community to ensure an appropriate time frame for the transition to mail order as the primary method of fulfillment. We remain committed to providing uninsured patients the most convenient, efficient and secure way to receive our HIV medicines.”
Gilead said “there are no changes” to its PAP’s co-pay coupon program for insured patients. It said it is giving uninsured patients enrolled in its PAP the option of receiving free HIV medicine by delivery because, “We heard from patients and providers that patients would like their medication shipped to the address of their choice, especially during the COVID-19 pandemic.”
“NASTAD is pleased that discussions between Gilead Sciences and national advocacy leaders have prompted the company to hold its plans of requiring mail-order delivery via a single specialty pharmacy,” NASTAD told 340B Report this morning. “Creating a mail-order option makes very good sense; making it a requirement, without nuanced discussions and community input regarding the potential impact on vulnerable patients and programs and sustainable solutions, would have been very damaging.”
In its email last week to its members, NASTAD noted that “mail order/courier delivery via a manufacturer-contracted pharmacy” would bring Gilead’s PAP “into alignment with the fulfillment mechanisms established by most other HIV drug product manufacturers” for their PAPs.
In a federal lawsuit in November, Gilead accused two groups of Florida health care providers, pharmacies, and labs—including 340B sexually transmitted disease clinics and their contract pharmacies—of making at least $43 million in fraudulent purchases of its HIV pre-exposure prophylaxis drugs Truvada and Descovy.