The Cardiologist’s PCSK9 Script: 6 Months of Frustration

When PCSK9 inhibitors first came on the scene for lipid lowering, interventional cardiologist William O’Neill, MD, medical director of the Center for Structural Heart Disease at Detroit’s Henry Ford Hospital, jumped right in — as a patient.

As a participant in an alirocumab (Praluent) clinical trial, O’Neill saw big benefits and predicted substantial use of the new drugs in his own practice when he was profiled on MedPage Today around the time of approval.

However, that hasn’t been so easy, as O’Neill told MedPage Today when we caught back up with him. A minimally-edited version of that conversation follows.

O’Neill: I am a practicing interventional cardiologist and I’m also a patient because I have familial hypercholesterolemia and I was a participant in the randomized OSLER study.

Phend: From which long-term results recently came out in JAMA Cardiology.

O’Neill: Yes, then the drug got approved, which is good and bad. It was good because it was commercially available and bad because it was impossible to get insurance to reimburse for it. I was on the study drug until last October, and that was the last study medication that I got. And it took 6 months to get the approval for the insurance company to pay for it. And the kind of stuff that they wanted, the level of detail that they wanted was honestly ridiculous.

They wrote a letter saying that they hadn’t seen in a pharmacy prescription that I’d been on three cholesterol-lowering drugs and they wanted proof that I couldn’t tolerate three cholesterol lowering drugs. They didn’t see that my LDL was high enough but I’d been on a study drug for 4 years so it wasn’t high enough. [Laughs] So it was really incredibly difficult. As a believer in the drug, I’ve been trying to prescribe it to my patients since commercial approval but right now I’m zero for six. I haven’t been able to get a single patient on the drug who in my clinical judgment would benefit and it’s primarily people who are statin intolerant, who really have terrible side effects of myositis and really physically cannot take the drug, and they haven’t been taking statins and their LDLs are way out of whack. It’s impossible to get them reimbursed.

Phend: You said you were finally able to get on after 6 months. Do you think that had anything to do with you being a physician and knowing how to work the system?

O’Neill: Absolutely. I got the letter, and it was a detailed letter about what it was they thought made me not qualified. I was previously at the University of Miami and I had to go back and get medical records that were more than 12 years old to try to demonstrate that without treatment what my baseline level of LDL was and I had to demonstrate to them on old records that I’d been statin intolerant and had an elevation of my CK enzyme to show I actually had myositis on statins. So that’s for me because I was absolutely damned and determined that I was going to be on…

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