In this segment, Cheryl Allen, BS Pharm, MBA; Bryan Bray, PharmD, CPP; Jeffrey Dunn, PharmD, MBA; Jennifer Reiter, PharmD, BCPS, BCACP, BCADM; and Peter L. Salgo, MD, provide insight on the challenges in treating cardiovascular disease from a clinical and cost perspective.
Peter L. Salgo, MD: Let’s check off some of the challenges that I think I heard going forward. We’ve got the lack of screening. It’s an asymptomatic disease. People aren’t coming in. We’ve got providers who may or may not really be on the ball in terms of treating globally as opposed to in a particular slot. Where does the specialty pharmacy come in with all of this?
Cheryl Allen, BS Pharm, MBA: That’s an interesting component, because with cardiovascular disease, historically that's not been a specialty population. The patients aren’t in specialty pharmacies unless they have comorbid specialty conditions. And those prescribers (likely the surgeons that put in the stent, the cardiologist who’s working with the patient, and the general practitioners), are not familiar with specialty, so it can be quite a challenge. Many times, the specialty pharmacy isn’t dealing with the statin therapy. The first time we will see some of these patients is with the newer medication requests for the PCSK9s (proprotein convertase subtilisin/kexin type 9s).
Jeffrey Dunn, PharmD, MBA: That’s where we need to focus—better coordinated care management, or better medication therapy management, and then closing the loop between all of the different stakeholders that are involved in a patient’s care. But even then, we’re going to have issues. We need to address cultural barriers, cost, and demographics. There’s all kinds of things that factor into a patient. This is going to be the challenge for a payer. It’s moving from population-based to patient-based. A lot of what we do is population-based, but there has to be, with a disease state like this (with all of the different comorbidities and moving parts), more of an individualized approach.
Peter L. Salgo, MD: Now we come down to something we’re hearing more and more about in the literature, which is this heterozygous familial hypercholesterolemia. Is it under recognized? And how common is it in the United States?
Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: I’m certain that it’s under recognized. We know that at least a million people have familial hypercholesterolemia or atherosclerotic disease, and that is probably a very low estimate. It goes back to, are we screening people appropriately? Those sorts of things.
Peter L. Salgo, MD: It’s a big problem, right?
Bryan Bray, PharmD, CPP: Yes, it’s a big problem. The data will say between 1 in about every 300 to 500 patients actually have the disease. It’s a big problem, too, because you really require greater than 50% reduction in their low-density lipoprotein (LDL) to make a clinical impact (which is a difficult thing with current medications we have available to treat). And I think the other issue is, as you mentioned, it being under recognized—I think it is. In our practice, the application of the Dutch Lipid Classification is not commonly done in private practice.
Peter L. Salgo, MD: What does that mean?
Bryan Bray, PharmD, CPP: That’s just a scoring system to determine whether a patient actually has familial hyperlipidemia or not. And when we see a patient, if that LDL is greater than 190 mg/dL, if they have tendon xanthomas, and if they have family history of early onset coronary artery disease or personal onset, then that patient has likely got it. And then you can do some DNA testing as well to prove it. But I think it’s just under recognized. We often will see a patient in a primary practice. They may have a high LDL, and we don’t really apply the classification to them. We just treat them.
Peter L. Salgo, MD: I want to get to that.
Bryan Bray, PharmD, CPP: We’re going to treat them anyway.
Peter L. Salgo, MD: You’re going to treat them anyway, right?
Bryan Bray, PharmD, CPP: Right.
Peter L. Salgo, MD: But what I’m hearing from you, if I’m hearing it right, is that these are people who are going to be particularly resistant to treatment. They’ve got a big genetic driver, and they’re not going to respond as nicely to statin therapy as somebody else might.
Bryan Bray, PharmD, CPP: That’s correct, because you want to get that greater than 50% reduction in the LDL, and it’s just difficult to do with statin alone.
Peter L. Salgo, MD: Do you need to do genetic testing? You implied that you actually looked at patients. You look at the xanthomas and you talk to patients who’ve got a family history. All that is going to make the diagnosis. You shouldn’t need a genetic test, should you?
Bryan Bray, PharmD, CPP: That’s correct. I don’t think so.
Peter L. Salgo, MD: Are payers going to require genetic testing?
Jeffrey Dunn, PharmD, MBA: It depends on the payer.
Peter L. Salgo, MD: They are requiring genetic testing.
Jeffrey Dunn, PharmD, MBA: And, really, where the risk is (if you’re self-funded, or if you’re fully funded). And there’s all kinds of factors that go into that. It’s across the board. I can say, we’re not. We require physician attestation, but I think it’s a minority of payers will ask for it.
Peter L. Salgo, MD: I was going to just go over this.
Jeffrey Dunn, PharmD, MBA: They might ask for chart notes or something.
Peter L. Salgo, MD: If somebody sends you a request for whatever, based on a presumed diagnosis of familial hypercholesterolemia, and they say, “I have established a family history, xanthomas on exam. and I’ve got this cholesterol level,” are there payers who are going to say, “Not enough, doctor. Go do the DNA test?” How much does that cost, by the way?
Jennifer Reiter, PharmD, BCPS, BCACP, BCADM: And is the payer going to pay for that?
Peter L. Salgo, MD: Yes, who’s going to pay for it?
Cheryl Allen, BS Pharm, MBA: With the PCSK9s, about 80% of the initial requests for therapy were denied, and it’s for some of those same reasons. It’s because, in clinical practice, we don’t have these types of tests—diagnostic tests and genetic tests— that are being done outside of the lipid levels. So, when a payer has a criteria where we’re requiring all of this documentation, the documentation is not there to support. So, initial 80% denial, and then on redirect for an appeal, less than 60%, ultimately, get approved.