@article{3565b4f17a774626bcb0eec73580b669,
title = "Enhancing the value of PCSK9 monoclonal antibodies by identifying patients most likely to benefit. A consensus statement from the National Lipid Association",
abstract = "Acquisition costs and cost-effectiveness have limited access and recommendations to use proprotein convertase subtilisin/kexin type 9 (PCSK9)–inhibiting monoclonal antibodies (mAbs). Recently, prices were reduced by 60% for alirocumab and evolocumab. This statement systematically reviewed subgroup analyses from statin and PCSK9 mAb trials to identify higher risk groups for which PCSK9 mAbs at the new price could be considered a reasonable (<US$100,000 per quality adjusted life year [QALY]) or high (<US$50,000 per QALY) value. In patients at extremely high risk, with a high burden of athersclerotic cardiovascular disease (ASCVD) or ASCVD with multiple poorly controlled or adverse risk factors, PCSK9 mAbs can provide reasonable value when low-density lipoprotein cholesterol (LDL-C) is ≥70 mg/dL. In patients at very high risk (ASCVD without peripheral arterial disease and lower levels of poorly controlled risk factors), PCSK9 mAbs provide a reasonable value when LDL-C levels are ≥100 mg/dL. High-risk patients (less-extensive ASCVD with well-controlled risk factors) may experience reasonable value when LDL-C levels are ≥130 mg/dL. Patients with heterozygous familial hypercholesterolemia or severe hypercholesterolemia with untreated LDL-C levels ≥220 mg/dL also should experience reasonable or high value from PCSK9 mAbs when LDL-C is ≥100 mg/dL for primary prevention and ≥70 mg/dL for secondary prevention.",
keywords = "Cost-effectiveness, Ezetimibe, Familial hypercholesterolemia, PCSK9 inhibitors, Secondary prevention",
author = "Robinson, {Jennifer G.} and Jayanna, {Manju Bengularu} and Brown, {Alan S.} and Karen Aspry and Carl Orringer and Gill, {Edward A.} and Anne Goldberg and Jones, {Laney K.} and Kevin Maki and Dixon, {Dave L.} and Saseen, {Joseph J.} and Daniel Soffer",
note = "Funding Information: Jennifer G Robinson, MD, MPH, has received research grants to the institution from Acasti, Amarin, Amgen, AstraZeneca, Esai, Esperion, Merck, Pfizer, Regeneron, Sanofi, and Takeda and served as a consultant for Medicines Company Amgen, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron and Sanofi. Manju Bengularu Jayanna, MBBS; Carl Orringer, MD; Edward A. Gill, MD, FNLA, FASE, FACP, FACC, FAHA; Laney K. Jones, PharmD, MPH; and Joseph Saseen, PharmD, FNLA, have nothing to disclose. Alan S. Brown, MD, FACC, FNLA, has served as a consultant and participated in speakers bureaus for Amgen, Sanofi, Regeneron, Amarin, and Kowa. Karen Aspry, MD, MS, FACC, FNLA, FAHA, has received research funds from Amgen, AKCEA, and Esperion and speaker honoraria from Medscape/WebMD. Anne Goldberg, MD, FACP, FNLA, has received research grants to the institution from Amgen, Amarin, IONIS, Novartis, Pfizer, Regeneron, and Sanofi, served as a consultant for Akcea, Esperion, Novartis, Sanofi/Regeneron, and provided editorial work for Merck. Kevin Maki, PhD, FNLA, has received grant support from Amgen, Acasti, Akcea, AstraZeneca, Matinas BioPharma, Sanofi/Regeneron and has received consulting and/or speaking fees from Akcea, AstraZeneca, Corvidia, Kowa, and Matinas BioPharma. Dave L. Dixon, PharmD, has served as a consultant for Lexicomp, Inc. Daniel Soffer, MD, FNLA, FACP, has received grants to the institution from AstraZeneca, Novartis, Regeneron, Akcea Therapeutics, NIH, and REGENXBIO, served as consultant for Amgen Inc, Akcea Therapeutics, Regeneron, Medicure, and as a speaker for Sanofi and Akcea Therapeutics. ",
year = "2019",
month = jul,
day = "1",
doi = "10.1016/j.jacl.2019.05.005",
language = "English (US)",
volume = "13",
pages = "525--537",
journal = "Journal of Clinical Lipidology",
issn = "1933-2874",
publisher = "Elsevier BV",
number = "4",
}