As PCSK9 Inhibitors Come to Market, Concern Over 2013 Guidelines Resurfaces

Topic: Atherosclerosis, Dyslipidemia Secondary CVD Prevention date: 08/10/2015 Featured Expert: N/A

Payers are asking the ACC/AHA to return specific LDL targets to their cholesterol-treatment guidelines.


Now that the first PCSK9 inhibitors have received FDA approval, the ambiguity of the 2013 ACC/AHA cholesterol-treatment guidelines are again being called into question. Because the new class of LDL-lowering agents are expensive specialty medications, with alirocumab priced at about $14,600 per year, payers are expressing concern that the removal of specific LDL-C targets from the 2013 guidelines will complicate treatment choices and inhibit utilization management tools, such as step therapy and prior authorization, to manage costs. Consequently, they are asking the American College of Cardiology and American Heart Association to return specific LDL targets to the guidelines.

In a recent publication in the European Heart Journal, however, Drs. Jennifer G. Robinson and Neil J. Stone explain the concept of net benefit, which was introduced in the 2013 ACC/AHA guidelines, and how net benefit can be used to identify patients most likely to benefit from statin therapy and which patients may benefit from the addition of a non-statin agent, such as ezetimibe or another LDL-lowering medication.

On Thursday, October 22 at the 10th Annual CMHC, Dr. Robinson will engage in a debate with Dr. Roger Blumenthal titled “IMPROVE-IT: How Do We Go Forward with the Guidelines?” on the use of the net benefit approach versus a return to specific LDL targets. The session will be moderated by CMHC Chairperson Christie M. Ballantyne, MD.

References: Shrank WH, et al. New therapies in the treatment of high cholesterol: an argument to return to goal-based lipid guidelines. JAMA. 2015; doi:10.1001/jama.2015.10017.

Robinson JG, Stone NJ. The 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk: a new paradigm supported by more evidence. Eur Heart J. 2015;36:2110-2118.

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