Switching to the Gilead Assistance program puts access to PrEP at risk, say HIV advocates

Dr. John Carlo is concerned that Prism Health North Texas patients who rely on the health care safety net will soon have even more difficulty staying on PrEP, a drug that prevents the transmission of HIV.

Carlo, chief executive officer of the clinic, which operates three locations in Dallas, is offering free PrEP to around 250 patients thanks to a Gilead Sciences assistance program, he said. The drug company currently makes two PrEP drugs.

The program also helps Carlo generate money to meet those in need of care with medication needs, such as regular doctor visits and laboratory tests.

Without Gilead’s help, Carlo said, “none of these people would be in our care.”

Nationwide, safety net clinics like Prism Health North Texas rely on Gilead’s Advancing Access Patient Assistance / Medication Assistance Program to fund services that keep patients in need HIV negative.

In April, Gilead announced that it would change the reimbursement through this aid program. For pharmacies that have contracts with certain safety net clinics such as Prism Health, the change means fewer reimbursement funds have to be passed on to the clinics.

The domino-like impact of the company’s move means Prism Health could lose between $ 2 million and $ 3 million annually, Carlo estimated.

The Advancing Access program offers free medication to the uninsured. Simply put, pharmacies dispense Gilead drugs to qualified patients for free. The pharmacies then submit claims to Gilead for reimbursement.

Shannon Stephenson, who runs a network of safety net clinics called Cempa Community Care in Chattanooga, Tennessee, said the new policy means working on a tighter budget and finding another way to get the nearly $ 2,000 in annual medical services alone to be able to provide patients with PrEP needs.

“It could really shift the future look of HIV,” said Stephenson. “This is not the time to put more barriers in order to bring people into care.”

Coy Stout, Gilead’s vice president of commercial access and reimbursement in the US, said the company didn’t know until its policy changed that safety net clinics relied on this money to fund critical services.

Gilead announced the change after discovering that pharmacies were being reimbursed at a higher price than most of them were spending on replacing the drugs.

The company didn’t want to say how much money it will save, but Stout said the move will help keep the aid program sustainable.

In 2020, the company made $ 24.4 billion in product sales, according to a press release from Gilead.

“This is a free drug delivery program,” said Stout, “not free drugs and other services.”

The pharmaceutical company is currently reimbursing pharmacies for the selling price of the drugs. HIV prevention drugs are expensive. Gilead’s PrEP drugs, Truvada and Descovy, cost more than $ 1,800 for a 30-day supply, said Sean Dickson, director of health policy at the West Health Policy Center.

In 2022, Gilead will give pharmacies “the amount paid” for each bottle of medicine. Certain safety net clinics will be harmed by the change as they participate in a separate program called 340B.

The federal program requires pharmaceutical companies to sell their drugs at a discount to providers of safety nets. Although the amount of discounts that drug manufacturers offer is confidential, the government estimates that they are between 25% and 50%.

In short, that means clinics participating in the 340B program will be reimbursed for the discounted price of the drug, which will allow them to pocket less money from the Advancing Access program.

Dickson said the amount clinics withhold from Gilead’s aid program is an important source of income to pay for services and medication for needy patients whom they otherwise cannot get.

“These are the really needy populations they care for,” said Dickson.

Clinics participating in the 340B program play a critical role in treating HIV-vulnerable patients, said Tim Horn, director of health care access at NASTAD, the National Alliance of State and Territorial AIDS Directors.

He is particularly concerned about providers in the south, where HIV rates and the uninsured are among the highest in the country. The region accounted for more than half of all HIV diagnoses in 2018, reported the Centers for Disease Control and Prevention.

Small base clinics in the south will “live or die on the 340 billion savings,” said Horn.

The financial upheaval caused by Gilead’s reimbursement change is raising major questions about the 340B program as a viable source of funding for PrEP services.

Several drug manufacturers recently launched generic PrEP drugs at a price significantly lower than Gilead’s branded offerings. Dickson said lower drug prices are a positive development for patients as it makes health care more affordable for everyone.

However, he added that moving to generic PrEP would prevent 340B clinics from making money from the drug company’s help.

Relying on high drug prices to fund the country’s safety net “isn’t a sustainable way forward, however,” said Dickson. “We actually have to pay for things that work instead of paying too much for prescription drugs.”

KHN’s senior correspondent Sarah Jane Tribble contributed to this report.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health topics. Together with Policy Analysis and Polling, KHN is one of the three major operational programs of the KFF (Kaiser Family Foundation). KFF is a non-profit foundation that provides the country with information on health issues.


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