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J Clin Lipidol. 2019 Jul 24. pii: S1933-2874(19)30237-5. doi: 10.1016/j.jacl.2019.07.005. [Epub ahead of print]

PCSK9 inhibition, atherosclerotic cardiovascular disease, and health economics: Challenges at the crossroads.

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Department of Public Health, I-CHER (Interuniversity Centre for Health Economics Research), Ghent University and VUB, Ghent, Belgium.
PCSK9 Forum Secretariat, Minerva Mill Innovation Centre, Alcester, UK.
Division of Endocrinology-Metabolism, Pitié-Salpétrière University Hospital, Sorbonne University, Paris, National Institute for Health and Medical Research (INSERM) and New French Atherosclerosis Society (NSFA), Saint Maur, France. Electronic address:



Improved survival after a cardiovascular event has led to an expanding patient population at very high risk of recurrent events. Reduction in low-density lipoprotein cholesterol, and thus implicitly non-high-density lipoprotein cholesterol, to guideline-recommended goals is a key tenet of secondary prevention. Yet, standard-of-care treatment with statin (with or without ezetimibe) often leaves a high risk of preventable cardiovascular events. Inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9), highly efficacious lipid-lowering treatments that confer reduction in cardiovascular events and death, clearly have a role in the personalized management of these very-high-risk patients. Given budget constraints, however, their integration into the health care pathway merits health economic considerations. Consequently, it is important to identify challenges at the crossroads of the clinical and economic dimensions.


Health economic analyses involve application of modeling scenarios integrating multiple parameters to ultimately yield values for quality-adjusted life-years and cost-effectiveness ratios. To date, these analyses have led to widely variable estimates of these benchmarks for PCSK9 inhibitors, causing confusion among stakeholders in the health care pathway. Clearly, a consensual approach to the conduct and reporting of health economic analyses involving all players, including noneconomists such as clinicians and patient advocates, is essential to bridge the gap between the clinical needs of patients and financial access to PCSK9 inhibition.


Atherosclerotic cardiovascular disease; Disease trajectory; Health economic modeling; Innovative pharmacotherapeutics; Low-density lipoprotein cholesterol; PCSK9 inhibitors


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