Peter Salgo, MD: Let’s take a look at some data. Let’s take a look at the official recommendations now. There’s the American College of Cardiology/American Heart Association (ACC/AHA) Blood Cholesterol Guidelines. Why don’t we just run through this. Who’s an appropriate candidate for statin therapy? And how much do the statins typically lower your LDL cholesterol?
Seth J. Baum, MD: First of all, the ACC/AHA guidelines are just 1 set of guidelines. We have the NLA (National Lipid Association) guidelines, we have the European guidelines, and we have the American Association of Clinical Endocrinology (AACE) guidelines, and they’re all different, frankly.
Peter Salgo, MD: Don’t you wish they would all get together in one room and hash this out? Wouldn’t that be nice?
Seth J. Baum, MD: Yes. So, ACC/AHA is the one that promotes a percent reduction in LDL cholesterol. The other ones still have targets or goals. So many of us, including Howard and I, follow the ones with the goals.
Peter Salgo, MD: What are the goals?
Seth J. Baum, MD: Somebody who is at high risk and is less than 70 mg/dL—although now, AACE has 1 that’s less than 55 mg/dL, and frankly, I think that’s appropriate.
Peter Salgo, MD: One thing I’ve seen in the literature is that there’s no threshold. Lower tends to be better.
Howard Weintraub, MD: But we knew that in 1994, when Scott Grundy, MD, from UT Southwestern drew a line, literally, down to the left. There was no level of cholesterol at which benefit did still not continue to accrue.
Peter Salgo, MD: I believe Steven Nissen, MD, had similar data, right?
Howard Weintraub, MD: Yes, he did.
Peter Salgo, MD: Okay. What are the guidelines? If 80 mg/dL is good, why not 70 mg/dL? Why not 55 mg/dL? Why don’t you guys just say, “We’re going to pay you to get it down to 30 mg/dL? We’re going to come back to that number.” That’s not a randomly chosen number.
Gary L. Johnson, MD, MBA: Well, our obligation, again, is to look at the evidence, look at the established guidelines, whichever they may be, and make our coverage decisions based on that—based on the guidelines.
Seth J. Baum, MD: But which guidelines? That’s the problem.
Howard Weintraub, MD: Correct.
Gary L. Johnson, MD, MBA: Again, you can certainly choose any guideline, but we generally choose the ACC/AHA guidelines.
Peter Salgo, MD: A patient comes in with a cholesterol that is above where the ACC/AHA likes it to be. He wants to, or she wants to, get that down, and he/she wants you to pay for it.
Gary L. Johnson, MD, MBA: And we do.
Peter Salgo, MD: But you do within some sort of structure. What do you want them to do? What is the mechanism by which you want them to approach this?
Gary L. Johnson, MD, MBA: It varies from insurance company to insurance company as to how strict things are. They want evidence that the patient needs the drug. For most plans, today, I would say that there is really no management of a statin therapy. In other words, the statins are generic medications. We don’t ask what their blood levels are. If they want to prescribe a statin, we cover it with no questions asked.
Howard Weintraub, MD: Now comes the idea of diet and exercise. If you didn’t and you’re on 80 mg of atorvastatin and your LDL is 120 mg/dL, in comes the request for Zetia. Zetia is still a branded drug, and the co-pays for that can be $60 to $90 a month. And sometimes, it’s disallowed. Why? Because the industry decides that that person’s risk was not high enough, based upon the ACC/AHA guidelines, to warrant the extra money. And that’s where the arguments start.
Gary L. Johnson, MD, MBA: I don’t know of anybody who would deny a coverage of Zetia.
Seth J. Baum, MD: Oh my.
Howard Weintraub, MD: I’ll give you my office number. I’ll be happy to supply it.
Seth J. Baum, MD: Yes, really.
Peter Salgo, MD: What does the ACC/AHA 2016 non—statin therapy guideline say?
Seth J. Baum, MD: Before I answer that, I need to ask you a question. Which group has primacy, the FDA or our guidelines?
Gary L. Johnson, MD, MBA: Primacy in the sense of what?
Seth J. Baum, MD: Who wins.
Gary L. Johnson, MD, MBA: Who wins?
Seth J. Baum, MD: Yes. There’s a disagreement. Who wins, the FDA or the guideline?
Gary L. Johnson, MD, MBA: Are you talking about off-label use?
Seth J. Baum, MD: No, I’m talking about FDA, on-label use in the prescribing information (PI). Who wins? Shouldn’t the FDA always win?
Gary L. Johnson, MD, MBA: I was going to say, yes, the FDA.
Seth J. Baum, MD: So, if you look at the FDA, and you look at the PI for the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, and we prescribe them completely on-label, we’re often denied. And the reason we’re denied is it’s not in the guidelines. So, the guidelines are used against the patients, whereas the FDA is ignored. That happens all day long.