HIV Guideline Update

Peter L. Salgo, MD: Let’s take a look at the DHHS guidelines right now. There has been an update for the use of the antiretroviral agents in adults and adolescents. How does this differ from what we used to have in the past?

Michael Sension, MD: Well what we have now is a new categorization where there’s a recommendation for most people and then there are drugs that are recommended in certain situations.

Peter L. Salgo, MD: Let’s talk about most people first. What is the usual therapy?

Michael Sension, MD: The simple way of saying it is that DHHS has weighed in on the data and said integrase inhibitors, across the board, are recommended in most situations.

Peter L. Salgo, MD: So, what are those drugs?

Michael Sension, MD: Dolutegravir, elvitegravir, and raltegravir.

Peter L. Salgo, MD: Those are, if you will, not the cocktail, but that’s the recommendation.

Michael Sension, MD: Integrase inhibitor-based regimens, but they are all used in combination. And, in fact, there are several single tablet regimens: dolutegravir/abacavir/lamivudine, better known as Triumeq, and dolutegravir with tenofovir and emtricitabine. And it would be a 2-pill regimen or an elvitegravir-based once-daily regimen.

Jeffrey Dunn, PharmD: So, that’s where I was heading with this. You look at the guidelines, and the guidelines change, which makes it a little bit more challenging to the payer as we set up formularies. But we want to follow the guidelines. These are not all single tablet regimens. So, they all have integrase inhibitors. I’m kind of curious. How important is it, 2 tablets once a day versus 1 tablet once a day? Is there a huge compliance and persistency difference? And is that something that we could potentially explore if it saved the patient money and it saves society money?

Michael Sension, MD: I think there isn’t any one of us that if we were going to see our doctor and they said, “I can give you 2 pills or I can give you 1 pill,” what would you prefer as a patient? What patient would say, “Oh doctor, give me 2.” I’d rather have 2 unless there’s a good compelling reason. And cost is not always a good sell to the patient.

Jeffrey Dunn, PharmD: But if the cost to the patient was considerably less, I wonder if that would.

Peter L. Salgo, MD: But is the patient seeing any of this cost at all? Isn’t that part of the issue?

Jeffrey Dunn, PharmD: Well, the challenge is we don’t have an HIV formulary, we don’t have an HIV benefit. We have a benefit, and because of the pipelines, specialty drugs, and the trends of these drugs, we’ve seen, in the past 5 years, a doubling of what we spend on drugs. And it’s probably going to double again in the next 2 or 3 years. So, we don’t have a lot of mechanisms to address that. The few mechanisms we have put the member in the middle of it. It’s moving to deductibles, it’s moving to coinsurance, it’s closing formularies. At some point, I think these patients either directly or indirectly will see the impact of the cost of these medications.

Peter L. Salgo, MD: Remember also the history of this was that early on in the epidemic, the perception, rightly or wrongly, was that the drug companies were pricing those primitive drugs by comparison to today’s drugs, usuriously. Price gouging is what people were concerned about and they were protesting about. I recall a group of people who chained themselves to the balcony in the New York Stock Exchange because of that.

Jeffrey Dunn, PharmD: Yes. Well inflammatory disease and the price increases of multiple sclerosis and hepatitis C have shifted the focus. But if you take a look at this, like I said earlier, this is still a top 5 or 6 category. And a lot of these single-tablet regimens are pushing $40,000 a year. So, they are very, very expensive.

Michael Sension, MD: But they lend themselves to a greater degree of adherence with much less side effects and much less safety concern over time. And remember, we started off this discussion saying that our patients are living longer, they’re going to be exposed to medications for years and years, if not decades. That could be key and important.

Jeffrey Dunn, PharmD: I definitely agree. The outcome and the cure and all the things we’ve been talking about definitely is still the objective. I don’t think we’ve had a very good cost conversation to date. I think that has to change a little bit, and where it potentially changes is, as we get more into single-tablet regimens and they’re made by different manufacturers or we have generics, is there an appropriate way to take advantage of that without affecting the patient and the outcome?

Elly Fatehi, PharmD, MPH: Well, I just need to remind everyone that managed care organizations don’t make these decisions in a vacuum. They take into consideration effectiveness, safety, and cost. So, all of these are taken into consideration when that formulary is developed.