Coming to U.S. pharmacies this month is Cimduo, from drugmaker Mylan.
It's very similar to Truvada (TDF/FTC), Gilead's blockbuster drug that's been used as a "backbone" of HIV regimens for more than a decade -- and that, since 2012, has found a massive new profit boost as the drug used for pre-exposure prophylaxis (PrEP), which actually prevents those who take it from acquiring HIV in the first place.
For reasons too boring to get into, Cimduo isn't technically a generic, and at 40% lower than Truvada's roughly $1,800 monthly sticker price, it's not exactly in the rock-bottom price category we may associate -- perhaps wrongly -- with generics.
But Anil Soni, head of global infectious diseases at Mylan, thinks the drug's sub-Truvada price still has the potential to drive down costs for everyone. "Hopefully," he wrote in an email, "[insurers] will pass on savings to patients through reduced copays and premiums, helping them in turn to better afford their medicines."
Related: Surprise FDA Approval of Generic Truvada Is a "Wakeup Call" for Activists
But there's good reason to believe that, despite its lower price, Cimduo just won't catch on. And the reasons point to the bigger issue of why it's so hard in general to bring down to earth the price of HIV drugs, which have historically been among the more expensive drugs on the market.
First, Cimduo was not tested as PrEP and, hence, is not U.S. Food and Drug Administration (FDA)-approved as an equivalent to Truvada for PrEP. And there is some suggestion that it would not work as well, since there are slight differences between Emtriva [emtricitabine, FTC], which is in Truvada, and Epivir [lamivudine, 3TC], which is in Cimduo. (Both pills also contain the exact same drug tenofovir disoproxil fumarate, or TDF, which is sold under the brand name Viread.)
Barring the unlikely event that a U.S. entity puts time and money into comparative trials, Cimduo can't cut into the PrEP portion of the Truvada market.
Second, in 2016, the FDA approved Descovy (TAF/FTC), Gilead's new alternative to Truvada that had been tweaked to reduce the potential kidney and bone issues associated with TDF.
Since then, many providers have switched their HIV-positive patients from Truvada to Descovy, and it appears that most public (Medicaid, Medicare, AIDS Drug Assistance Program [ADAP]) and private (Obamacare, employer-based) insurance plans have been paying for it.
"Since there is a good reason to use Descovy versus Truvada, I don't see insurers forcing us to use this cheaper version of Truvada," says Doug Ward, M.D., a Washington, D.C.-area HIV doctor. "So, I don't think Cimduo will make much of a difference."
In a statement, Mylan challenged that claim, saying that "hundreds of thousands" of people with HIV were still on regimens containing TDF, which is in Truvada; in Descovy, the TDF was swapped out for a compound called tenofovir alafenamide, or TAF.
But Ward is echoed by Jonathan D. Zellan, M.D., a Brooklyn, New York-based practitioner. "I don't imagine anyone using [Cimduo] when there is Descovy unless there were a financial or insurance issue," he says. "None of our patients have trouble getting their HIV meds covered, and co-pays are not an issue. If the insurance companies changed [what drugs they covered], then it would be a different story, but I imagine there would be a lot of pushback if [Cimduo] were preferred over [Descovy]."
Indeed, when it comes to driving down drug prices with copycats, alternatives, and generics, HIV is a uniquely tough nut to crack, explains longtime HIV-positive activist Tim Horn of the think tank Treatment Action Group and the Fair Pricing Coalition.
Generics for other ailments gain traction because very often people's employer-based plans or Obamacare insurance won't cover the highest-price brand-name drug, Horn says. However, on top of regular health care options -- including employer plans, Obamacare, Medicaid, and Medicare -- people with HIV can often turn to drugmaker charity programs and, importantly, the federal/state-funded AIDS Drug Assistance Programs (ADAPs) as payers of last resort.
As a result, people living with HIV often have multiple ways to get the newest, shiniest, and most expensive HIV drugs.
"Very few HIV patients feel the high cost of HIV treatment acutely because of this patchwork of coverage we have in place," says Horn. "But the actual price of these drugs is unsustainable over the course of people's lives, especially with the political risks currently faced by Medicaid and Obamacare plans. This may very well mean that the ADAP program will have to pick up more slack."
(Horn points to Georgia, where, a few years ago, because of cost considerations, the state Medicaid program said it would cover only one single-tablet HIV medication, Atripla (efavirenz/tenofovir/FTC), even though that pill had already become outdated because of side effects associated with Sustiva (efavirenz, Stocrin), one of its components. The decision was reversed after protest.)
A few doctors and advocates, at least, see a way forward for Cimduo.
Antonio Urbina, M.D., medical director of NYC's Institute for Advanced Medicine, points out that before Descovy came along, Truvada was used by people living with HIV for years, and its actual reported incidence of renal- and bone-related side effects was incredibly low.
"If a copycat or generic version comes with substantial savings, perhaps we could start with it, then only move to [Descovy]" if it's called for because of a patient's advancing age (which makes one more vulnerable to bone problems) or the appearance of side effects. "Perhaps this could motivate drugmakers to further reduce their costs," he says.
One purpose of Cimduo is certain: Technically, it opens the door for actual generic versions of Truvada within the U.S., of which there must be many to create enough competition to truly drive down prices. "Then Mylan will have to price Cimduo itself way down to compete," notes Horn.
Horn adds that he could very well see a place for such drugs in, for example, prison systems, which provide their own health care and are constantly looking for ways to cut costs.
And it's not as if HIV doctors don't know that FDA-approved generics are perfectly good alternatives to wildly priced brand names. Finally, many note, we are at a place where people with HIV can take an all-generic HIV cocktail.
"How about generic nevirapine [Viramune] and Epzicom [abacavir/3TC, Kivexa]?" says Ward. "If you don't get an allergic reaction" -- which forces less than 10% of people who take Epzicom to discontinue it -- "that's a very good, safe regimen which you can get for $140 a month."
Given that when HIV meds first came on the market in the late '80s and early '90s, they were among the most exorbitantly priced drugs ever seen -- and have only become more expensive in the past 20 years -- it's remarkable that lifesaving HIV drugs are now available in the U.S. for such a low price. And the advent of Cimduo suggests that more will come.
It's all about how willing providers and patients will be to play a role in balancing safety and efficacy against the long-term accessibility of HIV drugs in a fragile health care system whose root problem is unchecked prices on drugs and services.
With that concern in mind, the Fair Pricing Coalition just publicly welcomed the advent of Cimduo, calling it "a notable advancement in fair HIV drug pricing."
And that's an important point, stresses Horn. "As community activists," he says, "our allegiance needs to be with the patients. But we should at least be having this dialogue about cost."
[CORRECTION 4/12: An earlier version of this article included language that may have led the reader to erroneously conclude that the two HIV medications within Cimduo (tenofovir disoproxil fumarate and lamivudine) were identical to those within Truvada (tenofovir disoproxil fumarate and emtricitabine). We have corrected the headline and article copy to more clearly differentiate between the two.]