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Will New Evidence on PCSK9 Inhibitors Improve Patient Access?

For patients with extremely high cholesterol, the promise of new PCSK9 inhibitors just keeps growing. Data presented at this month’s American Heart Association meeting confirms that the breakthrough drugs lower LDL cholesterol – as anticipated. But it also reveals that the treatments can reduce the buildup of heart attack-causing plaque on the walls of coronary arteries.

Now the study’s results beg the question: Will new evidence of PCSK9 inhibitors’ impact lead to improved health plan coverage?

Study Details

As reported by the Journal of the American Medical Association, the study included 968 patients across North and South America, Europe and Asia. These patients added PCSK9 inhibitors to their current statin regimen for 76 weeks.

The treatment made good on its promise to lower patients’ LDL cholesterol. As explained by U.S. News & World Report, “Heart patients are told to aim for below 70, but some study participants got as low as 15.” For patients who took only statins, LDL lingered at about 93.

But participants also experienced a reduction in plaque buildup, which can amass over several decades. The lower that patients on PCSK9 inhibitors drove their LDL, the higher their likelihood to also reduce plaque. Plaque can ultimately cause heart attacks by leading to clots that block the flow of blood to the heart.

Access Challenges

More data is forthcoming, including studies with larger groups of patients. But will any of the evidence improve patients’ ability to access the medications?

Health plans deny 80-90 percent of prescriptions for a PCSK9 inhibitor, often requiring lengthy prior authorizations that frustrate doctors and leave patients empty handed. As cardiologist and AfPA member Seth Baum, MD, explained to The New York Times, denials can affect even those patients who need the breakthrough drugs most.

Though PCSK9 inhibitors are far more expensive than traditional statins, their value to certain patients is undeniable. Discounts are available through pharmaceutical companies, with Medicaid and the Department of Veterans Affairs receiving more substantial price cuts.

The debate over price, value and access will likely continue – as will health plans’ use of prior authorization to limit costs associated with PCSK9 inhibitors. But as patients wait, the threat of stroke and heart attack loom. For some, access can’t come soon enough.

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The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
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