In April, Gilead Sciences announced something that left many US community health clinics in panic.

Gilead manufactures several HIV treatment regimens, as well as branded versions of the only two drugs currently approved in the United States for PrEP, that is, pre-exposure prophylaxis. When taken as prescribed, PrEP protects HIV-negative people from transmitting the virus.

From 2022, Gilead said, its “Advancing Access” program – which provides free PrEP to patients who are not otherwise covered – will begin reimbursing these clinics for PrEP prescriptions (or “refills”). . at a much lower rate than they had before. The decrease will mean that these clinics will lose a large windfall that they spend on covering other PrEP expenses for their patients living in poverty, such as regular visits and the labs that come with PrEP.

Prism Health, a clinic based in North Texas, Newshour told PBS that they were in danger of losing $ 2 million to $ 3 million a year. (To put it in perspective, Gilead said he earned $ 24.4 billion in total sales in 2020.)

The reason for the loss is complicated, although the main reason is that these clinics participate in a government program called 340B – we wrote about this before – which forces drug wholesalers or middlemen to charge community clinics for them. refills at a rate greatly reduced from the retail price of the drug. In the case of Gilead’s charity program, Gilead then reimbursed clinics for its drugs PrEP, Truvada (emtricitabine / tenofovir disoproxil fumarate) and Descovy (emtricitabine / tenofovir alafenamide) at the full retail price of approximately $ 1,600 per bottle plus additional money for administrative expenses, or approximately $ 1,900 per fill. Under 340B, clinics may have paid wholesalers as little as $ 450 per fill, so they potentially received as much as $ 1,500 per fill for their own needs.

Without this extra money from Gilead, “none of these people would be healed with us,” John Carlo, MD, executive director of Prism Health, told Newshour, because, he explained, the extra money is intended for visits and patient laboratories. .

According to Newshour, Gilead claims they didn’t (somehow) know they were paying too much for clinics. Gilead’s decision to cut payments may have coincided with the discovery that several clinics and pharmacies in Florida allegedly abused the charity program, recruiting low-income people who didn’t actually need or want PrEP, and then writing them forms so they can cash in on the Gilead overpayments. (The drug maker sued these parts.)

Granted, Gilead’s impending cut creates a shortfall for many clinics that haven’t done anything fishy – and, in Newshour’s article, the drugmaker was careful to say that even though the excess- paid was an oversight, he never intended to fund PrEP. -related needs beyond the pill itself. TheBody contacted the HIV Prevention Division of the Centers for Disease Control (CDC), now headed by former New York City Deputy Health Commissioner and passionate PrEP advocate Demetre Daskalakis, MD, MPH, asking whether the agency could help fill that gap one way or another. .

A CDC representative responded by email, noting that the agency does not purchase drugs directly as part of its prevention programs, but then wrote: “We are, however, working on several fronts to ensure access to. PrEP by providing support to national and local health services. and other partners to scale up PrEP, including targeted funding to help deliver PrEP to those who need it most. In addition, CDC supports Ready, Set, PrEP, HHS [Department of Health and Human Services] program that provides free PrEP drugs to eligible people who do not have prescription drug insurance.

The representative also wrote: “The CDC continues to strive to increase access to pre-exposure prophylaxis (PrEP) and associated wrapping services through its own funding sources, including recently adding flexibility to [Ending the Epidemic in the U.S. (EHE)] funding requirements that allow communities to deliver inclusive services, including PrEP-related services, using EHE funds. We will continue to look for ways to expand access to these services.

A bigger problem looms for access to PrEP in the United States

Beyond Gilead’s reimbursement cuts, however, a bigger problem looms with access and adherence to PrEP. Access remains higher among white gay men than among black gay men – meanwhile, black gay men and black transgender women still have the highest HIV rates in the United States.

Earlier this year, key ingredients in PrEP became fully generic, flooding the market with retail versions for as little as $ 1 a pill. As with all drugs, major U.S. health plans like United Healthcare increasingly prefer to cover these generics over the expensive brand names of Gilead, Truvada, and Descovy, which means doctors will likely now have to do so. efforts to bring patients to one of the brands. names. Access to brand names like Descovy is important for patients with pre-existing kidney or bone problems, as some evidence suggests that they are safer for them than current generic formulations of PrEP.

With the advent of generic PrEP, Gilead’s charity program may soon follow the dinosaur’s path. Fortunately, the large percentage of the population covered by private insurance, Obamacare, Medicaid or Medicare can now easily get their generic PrEP covered.

Yet sadly, people who got their PrEP through the Gilead charity for lack of any other coverage may be left out if Gilead’s payment cuts mean they can no longer cover their PrEP-related visits and labs. . (In Newshour’s article, the head of a Tennessee clinic network said these visits and labs cost around $ 2,000 per year per patient.)

These people are often among the 4 million people in 12 states, mostly in the Southeast, including Texas, who have refused to expand Medicaid coverage to include not only the extreme poor, but the middle poor as well. These people, often of color, are not poor enough for their state’s stingy Medicaid programs, but are not “rich enough” to afford Obamacare, which can cost hundreds of dollars a month even if it is. receives government grants.

So when it comes to bridging racial and other gaps in PrEP coverage, that’s the biggest problem, says Kenyon Farrow of advocacy group PrEP4All (and, full disclosure, a former editor of TheBodyPro) .

“Until now,” he says, “there was a perverse incentive for high drug prices,” as 340B and drugmaker charity programs like Gilead have ensured clinics high reimbursement rates. which they could use to fund visits and labs for the uninsured.

“But now,” he said, “for the first time we have low-cost generics on the market for HIV drugs, so we have reached a crisis. We will have to think about the direction we want to defend. Getting Medicaid expanded in those refractory states, which also have high HIV levels and low PrEP use? It would alleviate a lot of the uncompensated costs, ”he says, as Medicaid would then cover visits and labs.

But then again, these deeply conservative states continue to refuse to expand Medicaideven in the face of offers from the federal government to cover the cost at 100% over the pre-existing 90% and in the midst of voting initiatives in some states that have requested expansion. Some Democrats in Washington, DC even support a bill that would allow residents of those states to register for Medicaid directly with the federal government.

Another option, with regard to PrEP, continues Farrow, is that “we may still need the federal government to create something like a stand-alone PrEP access program,” taking the savings on PrEP. generic and integrating it into enveloping PrEP services like clinic visits, labs, and maybe even transportation to get people to and from the visits.

Such a program, he says, could be modeled after the Ryan White program – which provides HIV drugs, care and other essentials to Americans not otherwise covered – or it could even be part of Ryan White, assuming Congress allocates extra money for this.

But the exploration of such directions is still in its early stages. “There is no community consensus on the way forward,” says Farrow.

It is echoed by Tim Horn, director of access to health care at NASTAD, an advocacy group of officials who administer HIV and hepatitis programs in the United States. “This conversation is starting to take shape, but it’s coming two years too late,” says Horn, who prefers a stand-alone program, not something within Ryan White. “The expansion of Medicaid would certainly help, but we will always have people who [earn too much for even expanded Medicaid], therefore a payer of last resort would be important.

Farrow and Horn agree that one thing is clear: we need to look beyond the 340B and charity programs, and the bizarre ways they are leveraging astronomical retail drug prices to fund basic health care in community clinics. . As more generics come online, such programs will generate much less revenue for clinics.

“Our funding for PrEP and prevention in the United States is a house of cards because we’ve become so dependent on that $ 340 billion in income,” says Horn. “We are now at a critical crossroads. We need to think about how we create sustainable solutions for these health centers and make these programs comprehensive. “

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