Lipid Management: Coverage Criteria vs FDA Labeling

Peter Salgo, MD: Since we’re talking about, now, nonstatins, what do the American College of Cardiology/American Heart Association (ACC/AHA) 2016 Nonstatin Guidelines say?

Howard Weintraub, MD: There are a couple of lines in there, but the guidelines themselves do not really endorse nonstatin medications. What they tell you is, “Set it and forget it.” If you are in a certain category, give the patient either a high-potency or a moderate-in-potency statin and then walk. The bell curve tells you that a third of these patients aren’t going to get where they’re going.

The role of ezetimibe was not articulated in the guidelines because they felt they didn’t have data. These were people who were all event-driven people. Articles were scientifically founded, well done, and had appropriate arguments. If it was not in an event-driven study, they would not recommend the drug. For example, they didn’t have data in people over the age of 75, so they excluded people over the age of 75 from getting intensive statin medicines. Now, the 76-year-olds are pissed at that, and I would understand why. And the same thing goes with diabetics. So, I think this was so strictly based upon large randomized placebo-controlled studies, and you can’t determine individualized medical care on the basis of what you would find out of a group of 20,000.

Peter Salgo, MD: In your view, in unpublished data, are you going to approve, or should you approve, people for FDA guideline use or FDA package use of medications for hypercholesterolemia even if it’s not part of the AHA guidelines? Or is that going to bankrupt?

Jennifer Strohecker, PharmD, BCPS: I think there’s a blend, and I think that’s why we have committees that are able to discuss this and balance each party’s views. One of the things is you are talking, from a specialist view, with regard to your ability to deliver medicine to patients from a cardiologist’s perspective. When you look from a family practitioner’s perspective, for example, that may not be able to delve into the details, how do we provide guidance for folks who may be practitioners (generalists) who are taking care of patients who have this lipid-lowering need? The challenge is to reach their goals.

Seth J. Baum, MD: I don’t think it’s your position to guide the clinician. The FDA, in approving a drug, stipulates exactly what that drug is indicated for. It’s in the prescribing information (PI), and you know the PI better than we know the PI. But you can read it and any physician can see exactly what’s in the PI. There’s no circumstance that I can envision where managed care, or a pharmacist, or anybody, should try to supplant what the FDA has already ordained. That’s a big problem. Basically, you’re undermining the patient/clinician relationship.

Gary L. Johnson, MD, MBA: I’m actually going to agree, 100%, with you because specifically under Medicare, we are obligated to provide coverage for FDA-labeled indications, and we actually even go beyond that. If there’s not an FDA indication, and there is a compendia support for a particular use, we’re actually obligated, under Medicare, to cover that, too. So, I’m not sure where the disconnect is coming in here. You’re saying that sometimes you get denied coverage for a patient?

Seth J. Baum, MD: Usually.

Gary L. Johnson, MD, MBA: Yes, when you’re prescribing a product according to the FDA labeling.

Seth J. Baum, MD: Absolutely. All day long.

Peter Salgo, MD: You haven’t seen that either?

Jennifer Strohecker, PharmD, BCPS: I should say, “I haven’t seen that as often.” We haven’t had as many requests for the newer agents.

Peter Salgo, MD: We’re going to get there.

Jennifer Strohecker, PharmD, BCPS: What we see is that they haven’t been adherent to other therapies first, and that might be where the denials come in.