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Editorials |19 February 2019

A Pound of Prevention? Assessing the Value of New Cholesterol-Lowering Drugs

Mark A. Hlatky, MD

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This article was published at Annals.org on 1 January 2019.
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Although cardiovascular disease has been decreasing for decades, it remains the leading cause of death in the United States. Further progress will require both optimal application of proven approaches and the development of new ways to prevent and treat atherosclerosis. Inhibitors of proprotein convertase subtilisin/kexin 9 (PCSK9), which substantially reduce cholesterol levels, are an exciting new approach based on insights from genetics and rational drug development (1). However, the U.S. Food and Drug Administration–approved PCSK9 monoclonal antibodies, alirocumab (2) and evolocumab (3), came to market priced at $14 000 per year—more than 100 times the cost of a generic statin. An ounce of prevention might be worth a pound of cure, but how much is a pound of prevention worth?
The 50% reduction in cholesterol levels from PCSK9 inhibitor use suggests that these drugs should reduce major adverse cardiovascular events: cardiovascular death, acute myocardial infarction, and ischemic stroke (4). Two large randomized trials of PCSK9 inhibitors in patients with clinically evident atherosclerotic disease who were already receiving statins showed reductions in cardiac events of 14% (2) to 20% (3), and both trials combined showed a 5% decrease in all-cause mortality (778 vs. 818 deaths).
Are these modest, yet important, reductions in cardiac events enough to justify the high cost of PCSK9 inhibitors? Several economic simulation models have examined this key question (5). All published models project that lifetime medical costs will be much higher in patients...
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Hlatky MA. A Pound of Prevention? Assessing the Value of New Cholesterol-Lowering Drugs. Ann Intern Med. [Epub ahead of print 1 January 2019]170:264–265. doi: 10.7326/M18-3632

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Published: Ann Intern Med. 2019;170(4):264-265.

DOI: 10.7326/M18-3632

Published at www.annals.org on 1 January 2019

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2019 American College of Physicians
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