A Pound of Prevention? Assessing the Value of New Cholesterol-Lowering Drugs
Authors: Mark A. Hlatky
Journal: Annals of Internal Medicine (2018)

Editorials19 February 2019A Pound of Prevention? Assessing the Value of New Cholesterol-Lowering DrugsMark A. Hlatky, MDMark A. Hlatky, MDStanford University School of Medicine, Stanford, California (M.A.H.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-3632 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail 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 ...References1. Navarese EP, Kolodziejczak M, Schulze V, et al. Effects of proprotein convertase subtilisin/kexin type 9 antibodies in adults with hypercholesterolemia: a systematic review and meta-analysis. Ann Intern Med. 2015;163:40-51. doi:10.7326/M14-2957 LinkGoogle Scholar2. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379:2097-107. doi:10.1056/NEJMoa1801174 CrossrefMedlineGoogle Scholar3. Sabatine MS, Giugliano RP, Keech AC, et al; FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-22. doi:10.1056/NEJMoa1615664 CrossrefMedlineGoogle Scholar4. Baigent C, Keech A, Kearney PM, et al; Cholesterol Treatment Trialists' Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267-78. CrossrefMedlineGoogle Scholar5. Hlatky MA, Kazi DS. PCSK9 inhibitors: economics and policy. J Am Coll Cardiol. 2017;70:2677-87. doi:10.1016/j.jacc.2017.10.001 CrossrefMedlineGoogle Scholar6. Amgen makes Repatha (evolocumab) available in the US at a 60 percent reduced list price [press release]. 25 October 2018. Accessed at www.multivu.com/players/English/8004559-amgen-repatha-reduced-list-price/ on 17 December 2018. Google Scholar7. Kazi DS, Penko J, Coxson PG, Guzman D, Wei PC, Bibbins-Domingo K. Cost-effectiveness of alirocumab. A just-in-time analysis based on the ODYSSEY Outcomes trial. Ann Intern Med. 2019;170:221-9. doi:10.7326/M18-1776 LinkGoogle Scholar8. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. J Am Coll Cardiol. 2018. doi:10.1016/j.jacc.2018.11.003 CrossrefGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Stanford University School of Medicine, Stanford, California (M.A.H.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-3632.Corresponding Author: Mark A. Hlatky, MD, Stanford University School of Medicine, HRP Redwood Building, Room T150, Stanford, CA 94305; e-mail, [email protected]edu.This article was published at Annals.org on 1 January 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoCost-Effectiveness of Alirocumab Dhruv S. Kazi , Joanne Penko , Pamela G. Coxson , David Guzman , Pengxiao C. Wei , and Kirsten Bibbins-Domingo Metrics Cited byLipid-Modifying Agents, From Statins to PCSK9 InhibitorsAtorvastatin-loaded SBA-16 nanostructures: Synthesis, physical characterization, and biochemical alterations in hyperlipidemic ratsAlirocumab not cost effective after recent first MI 19 February 2019Volume 170, Issue 4Page: 264-265KeywordsAutoimmune diseasesCholesterolDrug administrationDrug pricesDrugsInfectious diseasesLow density lipoprotein cholesterolPreventive medicineQuality adjusted life yearsStatins ePublished: 1 January 2019 Issue Published: 19 February 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...