Dr Seth J. Baum Discusses Payers' Reluctance to Approve Coverage of PCSK9 Inhibitors

At the American College of Cardiology 66^th Scientific Session, Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, president of the American Society for Preventive Cardiology, discussed why insurers are so reluctant to approve coverage of PCSK9 inhibitors and how this hesitance could harm patients who are denied access to the cardiovascular drugs.

Transcript (slightly modified)

Why are payers reluctant to approve coverage of PCSK9 inhibitors?

Well we know from the beginning, when the PCSK9 inhibitors were approved, there was pushback immediately, and the pushback was always a financial pushback. These are very expensive drugs, are they cost effective? A number of different studies were published utilizing QALYs [quality adjusted life years] to estimate the cost-effectiveness of drugs. QALYs, by the way, most people don’t know this, the Affordable Care Act actually banned the use of QALYs in economic determinations like this, pharmacoeconomic decisions, so they really shouldn’t be used in any of these papers, yet they are.

So it looks as though it’s strictly financial. Now, periodically, the insurers will say people are writing off-label. To my knowledge, it’s not generally true. Obviously, you’re going to find some outliers, always are going to, but the PI [prescribing information] for these drugs is very, very clear.

However, a group of us just published a paper that’s coming out the 20^th [of March] from Clinical Cardiology, which has a prior authorization that can be used for everyone but also defines the 5 elements of the PI with a 6-member coauthor group from varying groups and organizations. It’s a very simplified, very clear, very pragmatic product that defines these 5 elements and also employs a simple prior authorization, so hopefully the payers will embrace this and it will make the clinicians’ lives easier and it’ll make the patients healthier, so that’s the ultimate goal.

Do you think we will see insurers ease up on their requirements for approving these drugs?

We hope that payers will become less stringent with these requirements. FOURIER came out at this meeting. It was a very powerful outcomes trial that demonstrated the efficacy of PCSK9 inhibitors in a very short period of time, in just a 2-year trial, at reducing heart attack and stroke.

This is all about the patients. Patients have contracts with their insurance companies, and when a PCSK9 inhibitor is on formulary with those insurance companies and the patient is prescribed the PCSK9 inhibitor on label, they really are obligated to provide it.

I am hopeful that it will change. People are literally dying waiting for these drugs. That is not hyperbole. They are literally dying on line waiting for the drugs, so that has to come to an end.