New Lawsuit Could Affect PrEP Coverage

More on Braidwood vs. Becerra

No, this is not a lawsuit about the toxicities of PrEP medications; it’s a discussion about how the Supreme Court may be called on to make a decision that could affect the insurance coverage of PrEP prescriptions. Specifically, a federal appeals court has found that a component of the Affordable Care Act (colloquially known as “Obamacare,” a term that makes me cringe; it’s not like he invented it) that would require insurance coverage for a variety of conditions to be unconstitutional. At this point, the case could proceed through the lower courts, or be sent to the Supreme Court of the United States. We’ll have to see. Here is the piece:

Appeals court finds 'Obamacare' pillar unconstitutional in suit over HIV-prevention drug

Let’s dive in. Any emphasis is added by me.

A federal appeals court on Friday found unconstitutional a key component of the Affordable Care Act that grants a health task force the effective authority to require that insurers both cover an array of preventive health interventions and screenings and refrain from imposing out-of-pocket costs for them. 

The lawsuit centered on the objections of a coalition of small businesses in Texas to the requirement that they cover a drug for HIV prevention, known as PrEP, in their employee health plans. The appeals court did not, however, overturn the related ACA pillar; the practical, immediate impacts of its ruling apply narrowly to the plaintiffs in this case.

What are these “practical, immediate” impacts?

In response to Friday’s ruling from the 5th U.S. Circuit Court of Appeals in New Orleans, public health advocates expressed concern that, should the Supreme Court ultimately void the task force’s authority, this could compromise the nation’s already sluggish HIV fight.

“While we were predicting the worst, at the moment insurers will still have to cover preventive services, including PrEP, except for the original plaintiffs,” said Carl Schmid, executive director of the HIV+Hep Policy Institute in Washington, D.C. However, if the task force’s authority is ultimately voided, Schmid said, insurers will likely impose cost-sharing for PrEP, or not cover the newer, more expensive forms of it. He projected that such burdens would depress PrEP use among those at greatest risk of HIV. 

This could compromise the nation’s “already sluggish HIV fight?” The prevalence of “HIV” positivity in the United States has remained stuck at 0.3% of the population for forty years—this is hardly an exploding phenomenon. It doesn’t even behave like an infectious disease. However, I gather that this decision only affected the requirement, or lack thereof, of the “coalition of small businesses” in Texas that brought the suit.

The appeals court has also asked the lower court to review the constitutionality of the authority granted to two bodies within the U.S. Department of Health and Human Services to mandate insurance coverage for immunizations, contraception and other women’s preventive services.

Richard Hughes, an attorney at Epstein Becker Green in D.C. said he expects an ultimate appeal of the suit to the Supreme Court, because “essentially both parties,” including the plaintiffs and the Biden administration, “are going to be dissatisfied.” 

Hughes said it remains to be seen whether the parties will appeal to the Supreme Court in the short term or wait for the suit to wind its way through the lower courts.

The rest of the article discusses the “power—and lost opportunity—of PrEP.” Here we go. We are treated to the usual hand-wringing about how Black Americans are not accessing PrEP to the level that would be deemed acceptable.

According to the CDC, about 185,000 people, overwhelmingly gay and bi men, were taking PrEP during any one month of 2022. However, the use of PrEP, which nearly eliminates HIV risk if taken as prescribed, has always remained largely relegated to white gay men. Their Black and Latino peers have a much higher HIV acquisition rate.

Public health experts predict that a voiding of the health task force’s insurance-coverage mandate would likely widen this disparity.

I was thinking the other day about the fairy tale that PrEP provides “>99% efficacy” on “acquisition of HIV.” We have already discussed how the clinical trial evidence does not support this assertion, as the “99%” figure represents a theoretical efficacy derived from drug concentrations in dried blood spots and not actual real-world data. Another thing that occurred to me is regarding this trope that PrEP failure (meaning “seroconversion” while on PrEP) in real life is “rare,” despite it not being rare in clinical trials. The “rare” failures must necessarily be limited to those rare, rare cases of perfect adherence, making those data nearly meaningless.

Finally, how might these legal decisions affect insurance coverage for PrEP?

In 2019, the task force issued an A rating for the drug Truvada as PrEP. Consequently, almost all insurers were required by the ACA to cover PrEP with no cost-sharing by 2021. The Centers for Medicare and Medicaid Services later announced that insurers also could not impose out-of-pocket expenses for the quarterly clinic visits and lab tests required for PrEP users.

And now, in a display of rampant obviousness—the higher the copay, the less likely an individual will buy the medication, especially for someone that doesn’t even have the condition being treated by the medication.

Lorraine Dean, a Johns Hopkins epidemiologist, said keeping PrEP totally free “helps promote people’s ability to get it.” 

Dean led a study published in January in the journal Health Affairs that found the higher the PrEP copay, the more likely people were to abandon the prescription. Her team speculated that going from zero cost sharing to a copay of up to $10 would double the abandonment rate, to 11%.

Finally, how would this affect injectable PrEP?

An ultimate voiding of the task force’s mandate would throw into doubt access to present and future brand-name forms of PrEP.

A long-acting form of PrEP called Apretude, which is given every two months and is much more effective at preventing HIV on a population level than Truvada (given people often don’t take the oral drug as prescribed), was approved in 2021. 

However, given that Apretude’s list price is over $2,000 per month, securing insurance coverage can be challenging. Its use remains scant.

I can see why “its use remains scant” at that price tag. I’d also like to point out the use of language here—Apretude is more effective on a population level than Truvada at preventing “HIV.” This is a neat linguistic trick to cover up the lack of evidence that Apretude is efficacious on an individual level, which is what should matter to patients. These linguistic tricks are all over the place in reporting on HIV AIDS, and once you start to see them, you will notice them everyplace.

But should the task force lose its insurance-coverage mandate, Horn said, any future revisions to its PrEP guidance that might have widened access to Apretude would lose most of their power.

What’s more, Horn said future, longer-acting forms of PrEP would be “even more out of reach for those who stand to benefit from them the most.”

In particular, Gilead’s lenacapavir, given via injection twice yearly, could gain approval for use as PrEP by 2025 or 2026. The company on Thursday released results from an advanced trial of the drug’s use as PrEP in cisgender women showing it was highly effective; a trial among gay and bi men is ongoing. The drug has a current list price for use as HIV treatment of $3,250 monthly. Horn is hopeful, however, that pharmacy benefit managers would negotiate steeper discounts for the drug’s use as PrEP.

We have discussed lenacapavir before; the idea of paying $3,250 a month for a semiannual injection is insane. That’s $19,500 per shot. And I think that is a good place to stop because we can see the intention behind this so clearly. It’s all collusion behind the scenes between government, pharmaceutical companies, and activists to retain as many people as possible in care forever and ever, thereby lining their pockets with profits from medications whose price tag per dose is nearly sufficient to buy a car. It’s outrageous.