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Formulary Decision-Making Challenges in HIV

Peter L. Salgo, MD; Jeffrey D. Dunn, PharmD, MBA; Michael G. Sension, MD; and Elly Fatehi, PharmD, MPH, discuss the challenges with payer management of HIV therapies.


Peter L. Salgo, MD: Let me see whether I understand what goes on where you sit, when you’re looking at drug regimens for patients who have HIV. This falls under the whole rubric of access issues, really. Who gets the drugs, which drugs, and how expensive are they? Do you say, “With this patient, it looks like we might as well just give him the guideline approach, or recommend it. He doesn’t seem to fit a carve-out. He doesn’t need a more expensive drug. Maybe he could even have one of these cytochrome P450-activating drugs because he’s not taking anything else.” Is that what you do?

Jeffrey D. Dunn, PharmD, MBA: We’re not doing anything right now because we can’t.

Peter L. Salgo, MD: Whenever you have these conversations, you pay them?

Jeffrey D. Dunn, PharmD, MBA: Pretty much. What I’m trying to ask, though, is, is there a way that we can frame an initial conversation around what’s going to work for the majority of patients? In an effort for me to get a lower price, we don’t want to play medicine knowing that for somebody who has concomitant hepatitis B or C or whatever, we can go to something else. Is there an opportunity for me? That’s where the challenge is. These are all 4 preferred regimens.

Michael G. Sension, MD: That’s what the guidelines have already done. In other words, I would be very concerned about whittling it down even more in having a treatment algorithm, having standing orders for HIV where the minute somebody comes in with HIV, you say, “Everybody gets started on this drug for the first time. And then for your second go-around, everybody gets this.” I think we really need to maintain individualized therapy for our patients. That’s straight out of the DHHS guidelines.

Jeffrey D. Dunn, PharmD, MBA: We don’t practice medicine, but I fully understand individualization. Here’s the issue: We’re just being told, “You can’t touch this.”

Peter L. Salgo, MD: Let me tell you what I’ve observed. Let’s take HIV out of this for a second. In many other areas, doctors always argue, “That patient’s a special case. He or she is different. And yes, he needs a bypass surgery, whereas the guidelines say to use beta-blockers and/or a stent.” Because you can’t standardize medicine. But in point of fact, in disease state after disease state after disease state, you can come up with an algorithm that is pretty rigid and does work, and then you go to the carve-outs in rare cases.

Jeffrey D. Dunn, PharmD, MBA: I don’t know whether anybody is proposing an algorithm. We don’t want to do that.

Peter L. Salgo, MD: But why not?

Jeffrey D. Dunn, PharmD, MBA: It’s too complicated. What we would like to do is say, “OK, most people could start with this regimen. But if you have X, then you have these options. If you have Y, then you have these options.” That’s all we wanted.

Michael G. Sension, MD: I agree with that, Jeff, but I think the DHHS guidelines do that already. In other words, I’ll concede to you. Say that as Magellan, we’re not going to pay for indinavir. We’re not going to pay for amprenavir. We’re not going to pay nelfinavir. We’re not going to pay for delavirdine. We’re not going to pay for saquinavir. We’re not going to pay for a lot of the drugs that are still FDA approved and were used in the ’90s and 15 years ago. But we will approve something that’s on the recommended regimen that is current and up-to-date in 2017.

Peter L. Salgo, MD: But some of them are more expensive than others, I’m assuming.

Michael G. Sension, MD: We still have patients on them, too.

Elly Fatehi, PharmD, MPH: If we take that approach, then he’s not going to be able to get the better deal with those preferred options.

Peter L. Salgo, MD: If you take away his tools—that is to say, the power of mass purchase—then he doesn’t have a lot of armamentarium here.

Jeffrey D. Dunn, PharmD, MBA: There should at least be a conversation about trying to find some kind of middle ground that doesn’t totally discount cost and doesn’t totally say to a payer, “You can’t touch this.” We need to have those conversations. The challenge with not covering some of these drugs is that a lot of these drugs still have utilization. So, something’s going on.

Elly Fatehi, PharmD, MPH: Well, you can grandfather the current users and PA new starts.

Michael G. Sension, MD: Could you restrict the people who prescribe? For us in the state of Florida, ADAP is the easiest formulary to deal with, the AIDS Drug Assistance Program, through the Ryan White CARE Act for people who don’t have insurance or are not insured. They add every new FDA-approved drug to the formulary. The caveat is that not everybody can write prescriptions for the ADAP formulary. It has to be HIV specialists. It has to be people who are recognized in that field.

Peter L. Salgo, MD: How do you get recognized, and who does the recognizing?

Michael G. Sension, MD: There isn’t an American Board of Internal Medicine Specialty in HIV medicine.

Peter L. Salgo, MD: My point entirely. Who’s making the determination?

Jeffrey D. Dunn, PharmD, MBA: Personally, we do this in a lot of other disease states where drugs are very expensive or require a lot of clinical expertise. We require a specialist’s prescription or at least a consult. I support that. At the same time, we have a lot of business in rural areas. And so, access is an issue. You still hope there’s a consult, but there are some sensitivities to access in prescribing.

Peter L. Salgo, MD: Let me see whether I heard you correctly. Your hands are tied. That is to say, if somebody writes a script, you’ve got to fill it.

Jeffrey D. Dunn, PharmD, MBA: Generally, for most payers, that’s how it works today.

 
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