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Treating America’s High Cholesterol with PCSK9 Inhibitors

Written by: Guest Author on Monday, September 28, 2015 Posted in: Home Infusion, Specialty Pharmacy


This new group of high-cost specialty medications is showing promise for lowering “bad” cholesterol.

By: Ron Lanton III, Esq.

High cholesterol is one of the widespread chronic diseases affecting Americans. According to the Centers for Disease Control (CDC), cholesterol is a “waxy, fat-like substance found in your body and in many foods. Your body needs cholesterol to function normally and makes all that you need.” However, too much cholesterol can clog arteries, which raises the risk of heart disease and stroke.

Below are some cholesterol statistics:

• 73 million adults in the United States have high cholesterol.
• Fewer than 1 out of every 3 adults with high levels of low-density lipoprotein (LDL) cholesterol has the condition under control.
• Less than half of adults with high LDL cholesterol are getting treatment to lower their levels.

However, promising data from a new study may change the way the medical community responds to high cholesterol. While statins and lifestyle changes have been recommended for treating this disease, a review of 24 clinical trials found that PCSK9 inhibitors significantly reduced LDL cholesterol. Essentially, PCSK9 inhibitors “target and inactivate a specific protein in the liver. Knocking out this protein, called proprotein convertase subtilisin kexin 9, dramatically reduced the amount of harmful LDL cholesterol circulating in the bloodstream.” It seems as though further study is needed to determine its longer term success rate as well as how to integrate the inhibitors into treatment regimens. Thus far, the U.S. Food and Drug Administration has approved Sanofi Regeneron’s Praluent Injection and Amgen’s Repatha with Pfizer’s Bococizumab still in clinical trials.

While excitement in the medical community is building over the potential these drugs have to offer, costs remain a concern. The list price of Praluent Injection is $14,600 a year as clinical trials show a 40% or more reduction in LDL cholesterol while Repatha costs $14,100 a year with a 54%-77% LDL reduction rate.

During the last year, the manufacturer and payer communities have been at odds with each other over the justification of rising prescription prices. As science improves and medications become more “transformative” with increasing success rates, many manufacturers believe that the percentage of improved patient outcomes justifies premium pricing. Notwithstanding current rebates and negotiated discounts, the insurance community has pushed back hard as they struggle with the logistics of how to pay for something that so many American consumers could use. While it can be argued that better medicines with premium pricing can significantly reduce long-term healthcare costs associated with chronic conditions, paying for these medications could cause several short-term headaches for programs like Medicare, Medicaid, and private insurance. It remains to be seen whose viewpoint triumphs in the current pricing tug of war.

For more information from Ron Lanton, please click here. To learn how Mediware can help manage your costly specialty medications with CPR+, click here.


 [1] Center for Disease Control (CDC)
[2] Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al.
[3] CDC. MMWR. 2014;63(04);3-27.
[4] Annals of Internal Medicine Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis
[5] Curfman, Gregory PCSK9 inhibitors: a major advance in cholesterol-lowering drug therapy
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