HIV Aids

Are Health Centers Needlessly Prescribing Pricey Descovy for PrEP Because They Get a Government Kickback?

“I’m very proud that we’re doing the honorable thing here.” Those are the words of Alex Gonzalez, M.D., M.P.H., the medical director of Boston’s Fenway Health, one of the country’s oldest and largest LGBTQ health centers. And he’s talking about the fact that, according to a Fenway study published in August, Fenway providers have only switched patients on the HIV preventive medication PrEP from Truvada (emtricitabine/tenofovir disoproxil fumarate) to Descovy (emtricitabine/tenofovir alafenamide) 12% of the time.

Why should that be a point of pride? Let us explain: Truvada and Descovy, extremely similar drugs, are both made by Gilead, the pharmaceutical giant that has made billions from both drugs, which are used both to treat HIV—in conjunction with other drugs—and prevent it—used alone. Gilead actually developed both drugs years ago but successfully sought approval from the Food and Drug Administration (FDA) for Truvada first, in 2012. It did not seek and obtain FDA approval for Descovy until 2019—just a year before the patent ran out on one of the two drugs in Truvada that was not already generic. The patent ending paved the way for generic versions of Truvada that were stunningly cheaper than the branded version—about $60 for a month’s supply instead of about $1,600.

At that time—to maintain their highly profitable lock on the PrEP market, most believe—Gilead undertook a massive marketing campaign with providers and the public alike, promoting a study showing that Descovy was safer than Truvada when it came to (the admittedly rare incidence of) kidney and bone complications. Most providers took the bait, dutifully switching both their HIV-positive and PrEP patients to Descovy before generic Truvada could even hit the market— which it did first last year, with one version that was not significantly cheaper than brand-name Truvada, then earlier this year, in a flood that brought that average bottle down to about $60.

Why Are Truvada Generics Being Underprescribed?

The generic boom potentially means that private and public insurers are better equipped to get PrEP to the Black and Latinx gay men and transgender women who need it most—communities at highest risk of getting HIV. But it doesn’t seem to be going that way. Despite the fact that many experts feel that generic Truvada is just as safe and effective for PrEP as Descovy—not to mention the fact that Descovy may cause weight gain and higher cholesterol—a new study in Open Forum Infectious Diseases finds that an average of one in six switches from Truvada to Descovy may not have been necessary. That is, they may not be among the small number of cases where it appears someone on Truvada is having the kind of kidney or bone complications that would justify the switch.

But some advocates feel that’s just the way Gilead wants it. They point to an October 2020 Gilead earnings report showing that the company touted the fact that, in last year’s third quarter, 46% of prescriptions nationwide for PrEP—nearly half—were for Descovy, which the company said “exceeded [the] goal of 40-45% of individuals on PrEP on Descovy by Q3’20.” (Of course, it should be noted, this was the same month that only the first generic Truvada hit the market, with many more—dramatically cheaper—versions hitting the market last spring.)

“What seems to be happening is that doctors are being encouraged to switch patients to Descovy based on the surface impression that it has a better safety profile,” said Kenyon Farrow, the managing director of Advocacy and Organizing of the group PrEP4All, which advocates for greater expansion of PrEP access, primarily by lowering the drug’s price. “But for most of us, generic Truvada is perfectly safe. The switch to Descovy has more to do with Gilead trying to hold onto its market share of PrEP users in the face of the generics.”

But providers at nonprofit LGBTQ and other health clinics like Fenway have another incentive to keep on prescribing Descovy, or at least also-pricey branded Truvada. It’s a convoluted government program we’ve written about before called 340B. Basically, it lets such clinics buy expensive branded drugs at steeply reduced rates *but& makes insurers reimburse them at the full price. This has opened up a huge revenue stream for community-minded clinics to give free visits, labs, case management, and other crucial services for uninsured or underinsured patients—especially in Republican Southeastern states that have not adopted Medicaid expansion.

It also encourages such centers to go on prescribing the most expensive version of a drug even when it’s not medically indicated—or even ideal. “It’s a tragically perverse incentive to keep drug costs high, in order to funnel funds into community [clinics],” said Farrow.

Few Health Centers Got Back to TheBody on This

Whether for 340B revenues or simply because they don’t know any better, to what extent are U.S. LGBTQ clinics continuing to prescribe Descovy when it’s not really necessary? TheBody emailed—collectively, then individually—about 20 top LGBTQ-serving, mostly nonprofit health centers asking them for their PrEP prescription breakdowns. In addition to Fenway, the centers included New York City’s Callen-Lorde; Chicago’s Howard Brown; Philadelphia’s Mazzoni; Baltimore’s Chase Brexton; Los Angeles’ APLA; San Francisco’s SF Community Health Center; Columbus, Ohio’s Equitas; New Orleans’ CrescentCare; Indianapolis’ Damien Center; South Florida’s Broward Health; Mississippi’s My Brother’s Keeper; North Carolina’s Piedmont Health; Pittsburgh’s Metro Community Health Center; and Arizona’s Matrix Health and Southwest Center. (Many individuals emailed have previously spoken to TheBody for other stories.)

In addition to Fenway, the only centers who got back over the course of a week were New York City’s Callen-Lorde, Baltimore’s Chase Brexton, and Columbus’ Equitas (whose rep, who often reaches out to TheBody with story ideas, said that everyone was too busy to talk this time). It should be noted that some emails might not have gotten through, or simply weren’t seen.

At Callen-Lorde, medical director Peter Meacher, M.D., said that, in June 2021, the clinic’s PrEP prescriptions were 46% branded Truvada, 36% generic Truvada, and 18% Descovy. He said that some of the breakdown was due to what insurers would cover: New York State’s classic Medicaid program as well as its special PrEP assistance program still prioritized branded Truvada, while private insurers and the state’s managed-care Medicaid plans generally prioritized generics.

“There is a slow trend toward more generic Truvada over branded,” Meacher added. “But the rate of Descovy prescription for PrEP has remained consistent between 15% and 20%. I would think that the majority of [those patients] were switched to Descovy because they may have had some slightly underperforming renal function.”

He insisted, “We did not follow the bandwagon in a big move to Descovy in the last few years. We actually got together and agreed that sticking with Truvada was the best choice for most patients.” The center did this, he said, despite the loss of 340B revenues it would mean. “We made the decision to do the right thing and not let that influence prescribing decisions.”

At Fenway, Gonzalez said of the clinic’s low rates of switching patients to Descovy, “I wear that with a badge of honor—because when you take into account efficacy, side effects, cost, indications for PrEP, insurance coverage, and administrative burden, the consensus is that most people do not need to switch to Descovy.” He pointed out that Descovy, unlike Truvada, has not yet been approved for PrEP use in people with vaginas—cisgender women and transgender men—even if those groups make up a small amount of PrEP-takers compared to cisgender gay men.

Like Meacher, he said that Fenway was taking a hit by turning away branded PrEP 340B revenue. “It’s one of our most frequently prescribed meds,” Gonzalez said. “But we’ve looked at the science and concluded that Descovy’s advantages are just not strong enough for us to switch.” (He also noted that Massachusetts is one of several states that mandate default prescribing of generics over branded meds, except for necessary exceptions, such as a branded med having less side effects than a generic.)

In Baltimore, according to a rep for Chase Brexton, the pharmacy director said the clinic prescribed Descovy almost always. “However,” the rep added, “not every insurance has it on their formulary [list of covered meds], and in those cases, we default to Truvada.” The rep did not reply to TheBody’s query as to why Descovy is almost always prescribed.

With many states not offering Medicaid expansion, it’s easy to understand why so many nonprofit community clinics keep prescribing Descovy—because they need the 340B revenue it generates as a way of covering otherwise uninsured patients. But advocates say it’s a fundamentally flawed and unsustainable system.

“We should be taking the savings from generics and putting that money into the [educational and case-management] services we need to make PrEP more accessible,” said Farrow. “Poll after poll shows that the vast majority of the American public wants lower drug costs. The HIV community can’t keep saying, ‘Oh, no, we need to keep these drug costs high’ [to get the 340B revenues] in order to provide prevention, treatment, and care.”

Source link

Show More

Related Articles

Back to top button