James Underberg, MD: Statin Intolerance, Drug Costs in Cardiovascular Care

What beating hurdles in cholesterol care, such as high PCSK9 inhibitor costs or physician-perceived statin intolerance, come down to is a cardiologist’s insistence on adhering to the best care option available for their patient.

In an interview with MD Magazine®, internist James Underberg, MD, a clinical assistant professor in the Department of Medicine, NYU Langone Health, explained how the seemingly complicated maneuvers of getting patient’s cholesterol better can be resolved with common sense. What’s best for the patient?

MD Mag: Is there any hope to treat patients who are statin intolerant with alirocumab or evolocumab?

Underberg: Statin intolerance is in the eye of the beholder, or the eye of the definer, so to speak. So while neither of these drugs are specifically approved—evolocumab, alirocumab—in patients who are statin intolerant, they are approved on top of statin therapy. But that is defined as maximally tolerated statin therapy. Well, maximally tolerated therapy for one may be different from maximally tolerated statin for someone else. It doesn't specify everyone must be on the highest dose of the most potent statin, just that everyone must be on the most they can take. Well, the most someone could take might be 0 mg a day.

As long as that's been documented as to why, and that other statins have been tried, then I think that falls into the category of statin intolerance, although it doesn't specifically get defined that way. And as long as people understand that if they're trying to get a drug approved, the way to do it is to show that someone has failed statins—and so their maximally tolerated dose is zero. Do not to try to define them as statin intolerant.

What advice would give physicians attempting to get patients access to these therapies?

I think cost is always an issue, and managed care and prescription benefit providers are always going to try to push physicians and patients to pathways of lower cost when it comes to pharmaceutical intervention. And in many cases, that may be completely reasonable. But when standard therapeutic options have been exhausted, oftentimes the next line of therapeutic interventions are coming at a higher cost.

So, I think the key thing to do is make sure you're using the drugs in the right patient. I think that's a responsible way for anyone to be using drugs. That's the first step. The second is that if you are using the drug in the right patient, then you really should do everything you can to get the drug approved, because if you believe it's required for that patient, then that’s standard of care.

I think sometimes there are barriers that are pushed back at us as providers—forms, filling out checkboxes, documentation, a variety of different pieces of information that are required. But I think once you get in the habit of understanding and knowing what you're doing, that process becomes streamlined, and the perceived barriers are far less significant than we often believe them to be.