We prescribers of HIV medications — and our patients — have for the most part lived in a very privileged space in this country. Newer drugs with advantages in efficacy, safety, or convenience have generally been covered, either by private insurance or by government drug-assistance programs.
Drug coverage was historically so good that it even got the pole position in this blog; it was the topic of the very first post! In it, I half-sarcastically advised that the rest of our chaotic health care system adopt the same approach to drug benefits. What a simple solution, ha ha.
But I’ve been in this field long enough to know that this implicit assumption (“all HIV meds are covered”) was never going to last forever. And indeed, over the years, payers have applied increasingly close scrutiny to the high cost of antiretroviral therapy, sometimes by limiting choices, and sometimes — far worse — by proposing “alternatives” that are medically inappropriate or even dangerous.
If you’d like an example of the latter, and can tolerate a brief detour into my own wrath: one payer that refused to cover doravirine suggested efavirenz, rilpivirine, or nevirapine (!) as substitutes — despite the patient having already experienced intolerable side effects on efavirenz, and having clear contraindications to the latter two. In other words, the recommendation was not merely unhelpful, but truly dreadful.
As a result, over time we increasingly hear from patients that their well-tolerated, effective regimen is no longer covered. More commonly, it remains technically “covered,” but only with a punitive medication co-pay — which, as I’ve written before, is an irritating euphemism for the same outcome. Co-pay really means: You pay, not your insurance.
Our patients’ response to all this disruption? They hate it, of course — not just because of the cost, but because changing a stable HIV regimen reopens anxieties many thought they’d left behind.
Which brings us to Florida — a southern state with a large population of people with HIV, including several urban areas with among the highest HIV incidence rates in the country. Until recently, Florida had an extraordinarily generous AIDS Drug Assistance Program (or ADAP). An experienced HIV provider described the program to me as: “Honestly kind of crazy. I love it!” The formulary covered pretty much everything, including some truly high-ticket items.
But just announced were major cuts. What makes this different from the usual commercial insurance shenanigans is that ADAPs (or here in Massachusetts, HDAPs) function as the safety net for people with no other means to pay.
The most visible headline is a reduction in income eligibility, from 400% to 130% of the Federal Poverty Level — a substantial drop, and it’s not clear how those patients will now access lifesaving medications. Another major change affects the ADAP formulary itself. Most notably, Biktarvy will no longer be covered.
Excuse the one-time brand-name mention, but otherwise I’d have to write bictegravir-emtricitabine-tenofovir alafenamide (!!!), or BIC/FTC/TAF, or BF-TAF (all mean the same thing). Importantly, the state has indicated that “all other current antiretroviral medications,” including dolutegravir (Tivicay), will remain available.
For non-HIV treaters still reading, here’s some context: not covering BIC/FTC/TAF is like Shake Shack announcing it won’t be offering burgers and fries. You can still get a meal — just not the thing you’ve been ordering for years.
Indeed, this change is noteworthy because BIC/FTC/TAF is currently the most commonly prescribed HIV treatment in the United States. It is highly effective, well tolerated, simple, has few drug interactions, carries a low risk of resistance, and provides hepatitis B coverage. One of our recent fellowship graduates joked that learning other HIV regimens wasn’t worth the effort, since nearly everyone could just take BIC/FTC/TAF. While HIV experts may bristle at this oversimplification — our extensive ART knowledge demeaned! — there is, admittedly, some truth to it.
So what to do when BIC/FTC/TAF is no longer an option?
Because dolutegravir remains covered, one obvious alternative is to build regimens around this highly potent integrase inhibitor, which is very similar to bictegravir. The two-drug combination of dolutegravir-lamivudine would be the best option for most patients, especially if the branded coformulation (Dovato) is covered — it’s just exchanging one pill for another. If it’s not covered (the price in many states is similar to BIC/FTC/TAF) and the goal is cost-cutting, then the two-pill regimen of dolutegravir plus the very cheap generic lamivudine would do the same thing, with somewhat less convenience.
This less expensive regimen is almost as good as BIC/FTC/TAF for appropriately selected individuals, with three important caveats:
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It does not provide sufficient hepatitis B treatment, so it is unsuitable for people with chronic HBV infection.
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It is not appropriate for patients with lamivudine resistance.
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It requires taking two pills instead of one, which may matter for some patients more than others.
Another two-pill option is dolutegravir plus generic TDF/FTC, which retains hepatitis B activity and remains a familiar, guideline-supported regimen. The tradeoff here, of course, is the renal and bone toxicity associated with TDF, making it a less attractive choice for older patients or those with underlying kidney disease. TAF/FTC (brand name: Descovy) will reportedly be available only to individuals with reduced renal function.
The trigger for these changes is unsurprisingly budget pressure, attributed to rising health-insurance premiums nationwide and the absence of additional Ryan White funding. Those of us who prescribe HIV therapy should expect to see more of these cost-containment efforts from both private and government payers in the years ahead.
In that sense, Florida’s ADAP decision may be a harbinger of what I’ll call the looming statinification of antiretroviral therapy: a future in which payers mandate generic regimens unless there are clear contraindications. (And I’ll drop a patent on that word used in this context, so all future revenues derived from its use will flow to this blog.)
But here’s an important reminder: Just because something saves money doesn’t mean it will be welcomed by all — or that it will come without consequences, both good and bad. Let’s see how this unfolds, as apparently another large southern state is watching the Florida experience closely.
I wonder what that could be.