In The News

Accessing PCSK9 Inhibitors: An Ongoing Bottleneck for Patients and Their Doctors

by Seth J. Baum MD

PCSK9 inhibitors are the most significant advance in the management of elevated cholesterol in the last 3 decades. These injectable medications are indisputably revolutionary: They provide intensive and predictable reduction of LDL cholesterol in even our most difficult-to-treat patients. So, you would think that insurance providers would embrace them. Not so. On the contrary, insurance companies appear to be doing everything imaginable to keep you, our patients, from getting the medications that we, your physicians, believe would best help you. Though the current 80-90% prescription denial rate has been attributed by insurers to either inadequate completion of their required 3-8-page documentation or inappropriate physician recommendations, these accusations could not be further from the truth. Yes, the paperwork is onerous, but doctors and their staff accomplish far more difficult duties on a daily basis.

As for the indications for PCSK9 inhibitors, they are plainly stated in the PI, or Package Insert for the medications. You can read it yourself. In fact, I’ll quote it for you right here:
“… Is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).”

This language could not be more straightforward. It would be astonishing if doctors or patients failed to comprehend the meaning of these words. To see their simplicity for yourself, however, I will paraphrase: ‘If a patient has heterozygous FH (1/200-250 Americans) or clinical coronary artery disease and his/her LDL cannot be brought low enough with diet, exercise and medication, then he/she is a perfect candidate for these medications.’ Not so difficult at all. So why the insurance pushback?

Not surprisingly it all comes down to money. Your insurance companies simply do not want to pay for these medications. Refusing to honestly acknowledge the far more complex and costly production of injectable human monoclonal antibodies (the PCSK9 inhibitors) compared to small molecules (run-of-the-mill pills) insurance providers proclaim that the PCSK9 inhibitors are overpriced. If PCSK9 inhibitors were just a bit less costly they’d be happy to cover everyone, they assert. Their argument is untenable. If providers tell you that you are covered for these medications, then you are legally covered. Know your rights! The truth is that oftentimes your insurance company will tell you – on their websites and in their literature – that they do cover the PCSK9 inhibitors. And their declaration of coverage is exactly why you have the right and power to get these medicines when your doctor and you believe they are indicated. Again, under such circumstances it is your legal right to be treated with these drugs. So how do you fight the seemingly invincible system?

First, understand that you the patient can and should appeal your insurance provider’s denial whenever any of the following conditions apply: the provider will not pay for a service that is a benefit under your plan; the provider threatens to reduce or terminate a covered service that you have been receiving under your health insurance; the provider states that care is not medically necessary; the provider claims that you are not eligible for a particular benefit.

Second, you the patient must initiate the appeal. Apparently when patients actively engage in this process, insurance providers must track and document the entire process that ensues. On the contrary, when physicians begin the appeal, insurance providers can simply bury the communications and outcome. In the latter case, insurers are not held accountable.

Third, engage your physicians in this endeavor. Please know that we, your doctors, want only the best for you. That includes helping you fight for your right to obtain a medication you need and deserve. We will be by your side through this battle. That is our oath.

Fourth, if ultimately your insurance provider upholds your denial, do not surrender. Instead, contact your state’s Insurance Commissioner and Patient Advocacy group for help. They are powerful people who are also on your side. They will help you obtain medications you need and deserve.

Finally, though my persistent writing about this issue rightly implies we have yet to win this fight, please know that it also indicates that I wholeheartedly believe we will succeed. Let’s work together, patient and doctor, to make our victory swift and true.