Status of PCSK9 Monoclonal Antibodies in Australia

Daniel J Scherer; Adam J Nelson; Richard O'Brien; Karam M Kostner; David L Hare; David M Colquhoun; Philip J Barter; Philip Aylward; Stephen J Nicholls; Gerald F Watts

doi:10.1016/j.hlc.2019.04.014

Status of PCSK9 Monoclonal Antibodies in Australia

Heart Lung Circ. 2019 Oct;28(10):1571-1579. doi: 10.1016/j.hlc.2019.04.014. Epub 2019 May 8.

Authors

Affiliations

¹ South Australian Health and Medical Research Institute (SAHMRI), Adelaide, SA, Australia; University of Adelaide, Adelaide, SA, Australia. Electronic address: daniel.scherer@sahmri.com.
² South Australian Health and Medical Research Institute (SAHMRI), Adelaide, SA, Australia; University of Adelaide, Adelaide, SA, Australia.
³ Medicine, Austin Clinical School, University of Melbourne, Melbourne, Vic, Australia; Department of Endocrinology, Austin Health, Melbourne, Vic, Australia.
⁴ Department of Cardiology, Mater Hospital, University of Queensland, Brisbane, Qld, Australia.
⁵ Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Vic, Australia; Department of Cardiology, Austin Health, Melbourne, Vic, Australia.
⁶ School of Medicine, University of Queensland, Brisbane, Qld, Australia; Wesley Medical Centre, Wesley Hospital and Greenslopes Private Hospital, Brisbane, Qld, Australia.
⁷ School of Medical Sciences, University of New South Wales, Sydney, NSW, Australia.
⁸ Flinders University and Medical Centre, Adelaide, SA, Australia.
⁹ Department of Medicine, Monash University, Melbourne, Vic, Australia.
¹⁰ School of Medicine, Faculty of Medicine and Health Sciences, University of Western Australia, Perth, WA, Australia; Lipid Disorders Clinic, Department of Cardiology, Royal Perth Hospital, Perth, WA, Australia.

PMID: 31104887
DOI: 10.1016/j.hlc.2019.04.014

Abstract

Proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAb) have progressed from showing marked low density lipoprotein cholesterol lowering in early phase trials through to reducing cardiovascular events in large clinical outcome trials. Recently in Australia, the indication for evolocumab has been expanded to include both heterozygous and homozygous familial hypercholesterolaemia under the Pharmaceutical Benefits Scheme (PBS). With prices remaining high currently their use in non-familial hypercholesterolaemia in Australia remains by private prescription only at this stage. This manuscript summarises the major outcomes trials of the PCSK9 mAbs and the secondary analyses that have assessed their benefits in high risk patient groups, and describes the consensus of authors on which patients would most likely benefit from PCSK9 mAb therapy.

Keywords: Atherosclerosis; Cardiovascular risk; Lipids; PCSK9 inhibitors.

Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Publication types

Review

MeSH terms

Antibodies, Monoclonal / pharmacology*
Antibodies, Monoclonal, Humanized / pharmacology*
Anticholesteremic Agents / pharmacology
Australia / epidemiology
Cardiovascular Diseases / drug therapy*
Cardiovascular Diseases / epidemiology
Humans
Incidence
PCSK9 Inhibitors
Proprotein Convertase 9 / immunology*
Treatment Outcome

Substances

Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Anticholesteremic Agents
PCSK9 Inhibitors
PCSK9 protein, human
Proprotein Convertase 9
evolocumab