Peter Salgo, MD: Let’s talk about appropriate patients, which brings us, right now, to high-risk populations. I do want to save a little time at the end to talk about why you have to be high-risk if we can do better for everybody.
Howard Weintraub, MD: It’s a good point.
Peter Salgo, MD: But we’re going to start out with high-risk people because back in the day of the early statin therapy, only diabetics and smokers got statins. We’ve changed that. We could foresee a day where things might change. But for now, let’s talk about high-risk folks. You’re starting to treat a high-risk population. What follow-up do you do early on, and just mechanically in the office, to ensure that you’re getting a result?
Howard Weintraub, MD: You do a blood test, generally, after about 4 cycles, so at about 2 months, and you’re looking at this a) because it tells you if you’re giving enough drug because you do have a targeted goal and b) because it also helps the patient, it motivates the patient, to see how well they’re doing. And it helps you consider that if you’re not doing well enough, what do you have to do to get there.
Peter Salgo, MD: So, every 4 to 8 weeks, you’re going to bring them back, you’re going to check them, and then start to ramp up if necessary?
Howard Weintraub, MD: Exactly.
Peter Salgo, MD: Is that quick enough?
Seth J. Baum, MD: Yes, I think that’s good. I do the same thing—4 to 8 weeks.
Peter Salgo, MD: How did you pick 4 to 8 weeks, and where do you start? Do you start low? Do you start high? Do you start medium?
Howard Weintraub, MD: Actually, when you look at the exact recommendations, there is no absolute recommendation to bring them back to check.
Peter Salgo, MD: That’s my point. There’s no recommendation.
Howard Weintraub, MD: Right.
Peter Salgo, MD: It sounds great. It sounds like something a clinician would do, and by the way, I don’t disagree. But he’s going to say, “Where’s your evidence?” Aren’t you or no?
Seth J. Baum, MD: Yes, but wait a second. In the guidelines, in fairness, buried on page 82 or something like that, they do recommend that we follow up on LDLs to be sure that drugs are working. So, there is that recommendation. It’s sort of hidden, unfortunately.
Gary L. Johnson, MD, MBA: No. I was going to say that I think most companies—and again, it’s hard to generalize with managed care—but I think most managed care organizations do not get that deep into the weeds in terms of asking for follow up of laboratory results. We take what we call “physician attestation” (I know there was an issue here about what evidence we should require for the diagnosis of familial hypercholesterolemia [FH]). If the physician says they have it, we accept their word for it.
Peter Salgo, MD: You don’t read a genetic test? I’ve heard you do.
Gary L. Johnson, MD, MBA: Well, that’s my point. There may be some organizations or some companies that do that, but I’m just speaking in general terms. Most of the companies that I’m familiar with do not get into that much detail.
Peter Salgo, MD: Does it matter? If the LDL cholesterol is 250 mg/dL, does it matter how it got there? Does it matter if you were genetically predisposed because you have FH or because you were eating a cow a day? Does it matter?
Seth J. Baum, MD: It does matter.
Peter Salgo, MD: Why?
Seth J. Baum, MD: Because FH patients, in utero, have very high LDL. So they have a lifetime elevation.
Peter Salgo, MD: But that’s not my point. My point is somebody comes to you with this LDL.
Seth J. Baum, MD: But that increases their overall risk.
Peter Salgo, MD: Fine, but you’re going to do the same thing. You’re going to get their LDL cholesterol down. Why would an insurance company want genetic information if what you’re going to do is the same?
Seth J. Baum, MD: Well, genetics are an entirely different story.
Peter Salgo, MD: That’s my point.
Jennifer Strohecker, PharmD, BCPS: Right.
Howard Weintraub, MD: Right. But there are several different criteria to diagnose FH along with genetics. One of them is the Simon Broome Criteria, which involve knowing whether one of your first-degree relatives has bumps on their Achilles tendon. Now, I know as a child, I never inquired whether my father had bumps on his Achilles or elbow tendon, but they ask those questions. Are there extra cardiac stigmata of hypercholesterolemia? And if you don’t know this, I have been refused by companies (not yours, I’ve never dealt with your company or yours). They do deny, saying they cite that criteria and it’s a moving target.