Experts from the CVS health Research Institute are encouraging the review and reconsideration of current American College of Cardiology/American Heart Association (ACC/AHA) treatment guidelines for the management of high cholesterol in light of the new class of cholesterol-lowering drugs. The commentary is published in the Journal of the American Medical Association.

Researchers report that the launch of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors can complicate treatment choices and inhibit utilization management tools to manage costs. A consensus on management strategies for patients with high cholesterol is necessary given the big cost differential between proven older treatments this new class of drugs, stated William H. Shrank, MD, MSHS, Chief Scientific Officer at CVS Health.

Two years ago, the ACC/AHA guidelines shifted to a more aggressive management approach of lowering cholesterol with high-dose, high-potency medications if a patient was at elevated risk for cardiovascular disease. At that time, statins were the primary treatment for high cholesterol with proven improved outcomes as a highly effective, low-cost treatment option. However, these guidelines do not clarify how to choose the best evidence-based treatment that will result in cost-effective clinical outcomes.

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Inclusion of specific LDL targets would be important in determining where PCSK9 inhibitors best fit, experts concluded. An evaluation of the treatment guidelines can allow effective utilization management programs to help control healthcare costs and achieve desired outcomes.

In July 2015, the Food and Drug Administration (FDA) approved Praluent (alirocumab; Sanofi Aventis and Regeneron) as the first PCSK9 inhibitor to treat heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C.

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