Clinical and Economic Burden of Cardiovascular Disease

As an introduction to this Specialty Pharmacy Times^® Peer Exchange^®, experts Cheryl Allen, BS Pharm, MBA; Bryan Bray, PharmD, CPP; Jeffrey Dunn, PharmD, MBA; Jennifer Reiter, PharmD, BCPS, BCACP, BCADM; and Peter L. Salgo, MD, discuss considerations surrounding the clinical and economic burden of cardiovascular disease.

Peter L. Salgo, MD: Cardiovascular diseases represent a substantial portion of the current healthcare expenditure. Controlling lipid levels in at-risk populations remains an important part of prevention and management strategies. Now, emerging treatment with PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors represents a potential paradigm shift in terms of cholesterol management, and it’s likely going to require specialty pharmacy involvement to optimize the management and, also, to control the costs.

Today’s panel of experts for this Specialty Pharmacy Times^® Peer Exchange^® will provide an overview of the clinical and economic considerations of lipid-lowering therapy. The panelists are going to discuss the optimal management of cholesterol, including the role for the newer, more expensive therapeutic options.

I’m Dr Peter Salgo. I’m a professor of medicine and anesthesiology at Columbia University College of Physicians and Surgeons, and I’m the associate director of Surgical Intensive Care at New York-Presbyterian Hospital.

Participating today on our distinguished panel are: Ms Cheryl Allen, vice president of Industry Relations at Diplomat Pharmacy, Inc., in Flint, Michigan; Dr Bryan Bray, chief operating officer of Medication Management, and vice president of Piedmont Pharmaceutical Care Network in Greensboro, North Carolina; Dr Jeffrey Dunn, senior vice president and chief clinical officer of VRx Pharmacy Services in Salt Lake City, Utah; and Dr Jennifer Reiter, a clinical pharmacist at Indiana University Health Southern Indiana Physicians in Bloomington, Indiana.

Thank you all so much for joining us. We’ve got a lot to cover today, so why don’t we start with the basics. We’re talking about heart disease (cardiovascular disease) and the clinical burden of managing all of this. It’s substantial. About 1 in every 3 deaths is related to this problem, right? How big of a problem is this?

Jeffrey Dunn, PharmD, MBA: It’s a huge problem. It’s a huge problem for society, for payers, and for all of the stakeholders. You mentioned about 1 in 3 deaths are associated with cardiovascular disease. It’s also the comorbidities. So, cardiovascular disease is highly related to diabetes and other conditions. When you factor all that in, this (I would say outside of the specialty categories) is a top 3 priority for health systems and payers, along with asthma, COPD (chronic obstructive pulmonary disease), and diabetes.

But, again, there’s a link between diabetes and cardiovascular disease. We’ve done about everything you can imagine over the last 15, 20 years in trying to manage this disease state. But I would say there’s less emphasis, now, on the drug side, because other than the PCSK9s that are new and very expensive, a lot of the medications are generic. So, the real impact is on the medical side—death, stroke, myocardial infarction (MI), hospitalization, emergency room. Then, there’s also the indirect costs, which are huge. But that’s where we kind of struggle in trying to figure out what the indirect costs are.

Peter L. Salgo, MD: I don’t want to let one comment you made here go past because I think it signals this kind of tidal shift in medicine. When I started out, we didn’t have any statins. We didn’t have any good medications for cholesterol. If you were hypercholesterolemic, that was your risk factor. And then, suddenly, along came the statins. And you’re telling me now (and you can all chime in on this), that this is an old hat. This is a done deal. This is old and we can forget about that as an issue. Is that what you’re saying?

Jeffrey Dunn, PharmD, MBA: For the most part. Ten years ago, we were worried about statins. They were branded. This is a large population. We were looking at evidence. We were looking at efficacy and cost and were trying to make decisions (just like we’re trying to do now). But relative to the other things that we’re dealing with, the medication side is not the driver of this. It’s the medical side, and that’s also part of the problem. As we try to manage these patients, whether it’s a provider or a payer, it’s trying to integrate the medical and pharmacy data to really understand what the issues are.

Peter L. Salgo, MD: We’re talking about what, 800,000 deaths a year (give or take), of folks who die of cardiovascular disease, or stroke, or other vascular complications? And the price of the statins has fallen off a cliff, which I take it is what you were getting at.

Jeffrey Dunn, PharmD, MBA: Yes. They’re less than $5 a month (net), and most of the medications to treat cardiovascular disease are generic (with a few exceptions).

Peter L. Salgo, MD: I think it is fair to just remember where we were, because I can remember having this kind of a conversation about the statins, and we’re about to have some rather expensive drugs. I remember Lipitor. There was a whole debate whether branded Lipitor could stay on a formulary because it was going to break the bank, right? Remember that?

Bryan Bray, PharmD, CPP: Yes. I think of a couple of things. One is from a payer perspective. I did see data that said that 2100 people die per day from cardiovascular disease, and around 1 dies every 40 seconds from cardiovascular disease. But, when you think about it from the payer’s perspective, because cardiovascular disease is not an incidental thing that happens right now, it happens over years. And from a payer perspective, a lot of times you’ll see patients who switch payer source. So, we have patients just pop into the system, from payer to payer to payer, and nobody is really willing to take control in managing it correctly. So, that’s an issue.

Peter L. Salgo, MD: The issue is always going to be, do I pay now or pay later?

Bryan Bray, PharmD, CPP: Right.

Peter L. Salgo, MD: I pay for these expensive drugs with the caveat that I’d like to pay as little as possible.

Jeffrey Dunn, PharmD, MBA: Right. What we were talking about with statins 10 years ago, we’re now talking about with the PCSK9s. But we’re not managing statins. We’re not managing ACEs (angiotensin-converting-enzymes). We’re not managing ARBs (angiotensin receptor blockers). We’re not managing those anymore. The emphasis, now, is on the medical side. It’s the reduction in hospitalization, and reduction in events. And so, with that, our focus, now, is on programs like appropriate care management, medication therapy management, and the quality initiatives around STAR measures and HEDIS measures. It’s not the drug costs anymore.

Peter L. Salgo, MD: Let’s take a look at the modifiable risk factors that you were talking about, because that is medical management, but it’s also pharmacologic management. We are managing low-density lipoprotein cholesterols with statins, for example. And then, the other things that come up—there’s hypertension. What else is out there that you guys are concerned with every day?

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: Diabetes was mentioned, and obesity. We’re talking about care management and how much we’re stressing that in healthcare, now, and we can’t neglect that lifestyle modifications are so important in these patients.

Peter L. Salgo, MD: Good luck with that.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: Right. Anybody working in the clinical setting knows how hard it is to change behaviors. It’s hard, but we don’t want to neglect it now that we have all of these options. To his point, the statins are easy now, and even switching people on statins is so much easier than it used to be—getting on the potency that they need and helping to modify some of their risk factors by getting them on the appropriate therapy.

Cheryl Allen, BS Pharm, MBA: Don’t you think the challenge underlying this is patient compliance? Because these patients, and particularly the prescribers as well, these aren’t necessarily specialty patients. So, the compliance, overall, is probably somewhere around what, 45%, 55%?

Peter L. Salgo, MD: I’m surprised it’s that high. But, I mean, really, isn’t that the issue?

Cheryl Allen, BS Pharm, MBA: Exactly.

Peter L. Salgo, MD: The thought was (as I recall, when the statins came in), “All right. If you can just get them to take the statin, you can forget about their diet, because they’ll eat their steak no matter what you do, and eat their cream pie no matter what you do.”

Jeffrey Dunn, PharmD, MBA: When we talk about these programs, that’s exactly right. One of the main priorities within a medication therapy management program, or care management program, is the adherence/compliance component. Like any chronic disease state that’s asymptomatic, there’s always going to be persistency problems, so that’s a priority.

I think, from a payer or a provider, that the emphasis is understanding the patient, and it’s in that coordination. We focus on motivational interviewing and a lot of other things when we’re talking to patients because we want to understand what the issues are. Why are they not compliant? Is it because cost may be an issue? Or it may not be an issue. Is it concerns around safety? What exactly is going on? The key is, how do we help them become more compliant? At the end of the day, even with PCSK9s, if a patient is on a PCSK9 and we’re paying for that, we want to see the benefit of that drug.

Peter L. Salgo, MD: I want to come back to something that you mentioned, which is human behavior, because the answer to your question may be, why are they not compliant? Because they’re human.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: You see people shortly after an event who are very adherent to medications in those teachable moments (after they’ve had an MI or a stroke), and then, 2 years later, not so much. So, how do we keep them engaged and keep them adherent to their therapy, and how do we keep these programs continuing? And with these expensive drugs, it’s so much more important.

Jeffrey Dunn, PharmD, MBA: Yes. I just want to say the big buzz words, right now, are “motivational interviewing.” The other is “patient segmentation.” There are different payer types. There’s the “A+ student,” and there’s the “skeptic.” There’s different types of patients. And so, understanding that and understanding what’s driving them helps us better direct what we’re doing with the patient, so that we can get better outcomes.

Peter L. Salgo, MD: We could spend the next 90 minutes talking about obesity.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: Or longer.

Peter L. Salgo, MD: Or longer. You launched us on that. If I’m wrong, please tell me. I think there’s a special challenge here. I think that people will probably take their antihypertensives if you really work with, maybe, their anticholesterol drugs. But in getting their weight down—I got a sense that you were at least quizzical.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: That’s definitely a challenge, and there’s all kinds of challenges around that. The same that are around medication adherence and cost of healthy food. All of those sorts of things play into those decisions, as well. People living in food deserts and not having access to healthy foods…

Peter L. Salgo, MD: That’s a phrase I haven’t heard before—food deserts.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: Oh, yes. I work with a lot of dietitians.

Peter L. Salgo, MD: What is a food desert?

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: It can be different places. A lot of times, in rural communities (depending on farming around there) is there access to fresh, healthy food? Is the food that they have available just processed, unhealthy food?

Peter L. Salgo, MD: I got it.

Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: Sometimes you even hear about that in cities, because there aren’t readily available grocery stores. People are doing more quick meals, and take-out, and that sort of thing.