Impact of HIV Guideline Changes on Payer Decisions

Peter L. Salgo, MD: The drugs you were talking about are pretty much for run-of-the-mill patients. These are the people with HIV who are not exceptional and don’t have exceptional medical issues. But there are carve-outs in the DHHS (Department of Health and Human Services) guidelines for individual patient characteristics. What are they?

Michael Sension, MD: There is a nonnucleoside reverse transcriptase inhibitor, rilpivirine, that the clinical data look very compelling and good for, particularly in people who have viral loads at baseline less than 100,000 copies/mL. There is an allowance or a carve-out, if you will, for the rilpivirine-based regimen in the eyes of the DHHS guidelines. We also had to struggle with nonadherence issues through the years, for whatever reason—complicated side effects, complicated dosing schedules, or multiple pills—that led people to miss doses and develop resistance to their drugs. There’s a class of drugs, protease inhibitors and, specifically, darunavir-based regimens, that the DHHS guidelines have singled out as having a special role for people who may have problems with adherence or may be prone to miss doses.

Peter L. Salgo, MD: What you’re telling me is that there are some drugs that are less likely to develop resistance than others. Are they more expensive, these resistance-resistant drugs?

Jeffrey Dunn, PharmD: It’s hard to say. You have to look at the cost of the regimen when you’re making comparisons. It’s sometimes difficult to look at one drug versus another.

Peter L. Salgo, MD: It would make sense to reserve those drugs that are specifically targeted for individuals who are likely to get resistance, especially if they’re more expensive.

Jeffrey Dunn, PharmD: Well, this is it. Elly touched on this a minute ago. When we’re setting up formularies, we are looking at efficacy, safety, cost, dosing, utilization, and those types of things. But formularies are population tools, so we don’t want to stand in the way. What we’d like to do is get to a position where we can maybe have some preferred drugs based on the cost-effectiveness, a combination of clinical value and cost, but there’s always going to be an exception process to that. It’s never going to be 1-size-fits-all, so if there’s evidence to support that a certain drug or a certain regimen is better for a certain patient, then absolutely.

Peter L. Salgo, MD: Globally, from the 10,000-foot view, do these new guidelines change the landscape of the third-party payer?

Jeffrey Dunn, PharmD: I would say fundamentally, no. I think we’ve had a lot of preferred regimens in the past, but a lot of alternatives. There’s always a question: “Well, what’s the difference between a preferred and an alternative regimen?” The new regimens just move towards more integrase inhibitors. It’s always a challenge from a formulary perspective to keep up with the guidelines, but at the same time, if we have access in some manner to these drugs, I don’t think it does. Maybe it gets too narrow and maybe it’s 1 manufacturer. Then we’re not going to have an opportunity to address the increasing price component.

Michael Sension, MD: My challenge to you, Jeff, and my frustration perhaps with you—not you personally, but with the payer situation—is that I feel like they haven’t kept up as promptly and quickly as they could with guideline changes and new products and new drugs. What I’ve seen over the last few years is when new drugs come on the market, they really have a benefit. They have a benefit from safety, from simplicity, and from less side effects, and it’s very compelling to use them.

Jeffrey Dunn, PharmD: I would actually say it’s not on purpose. It’s just because this has been a hands-off category, and I just know from looking at a lot of my colleagues that they’re not managing this category. They just don’t get around to it. They put it on formulary, and that’s it. I think that actually refocusing on collaboration and formulary managing this might speed things up and get us to a better spot, if we can have these types of conversations. But right now, I think the fare is, “Well, we can’t do anything, so we don’t have to look at that.”