PCSK9 inhibitor access barriers-issues and recommendations: Improving the access process for patients, clinicians and payers.
The proprotein convertase subtilisin/kexin type 9 inhibitors or monoclonal antibodies likely represent the greatest advance in lipid management in 30 years. In 2015 the US Food and Drug Administration approved both alirocumab and evolocumab for high-risk patients with familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease requiring additional lowering of low-density lipoprotein cholesterol. Though many lipid specialists, cardiovascular disease prevention experts, endocrinologists, and others prescribed the drugs on label, they found their directives denied 80% to 90% of the time. The high frequency of denials prompted the American Society for Preventive Cardiology (ASPC), to gather multiple stakeholder organizations including the American College of Cardiology, National Lipid Association, American Association of Clinical Endocrinologists (AACE), and FH Foundation for 2 town hall meetings to identify access issues and implement viable solutions. This article reviews findings recognized and solutions suggested by experts during these discussions. The article is a product of the ASPC, along with each author writing as an individual and endorsed by the AACE.
Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida.
Seth J
http://orcid.org/0000-0001-9045-6607
SJ
Baum
CGH Medical Center, Sterling, Illinois, and Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Peter P
PP
Toth
Center for the Prevention of Cardiovascular Disease at New York University Langone Medical Center, New York, New York.
James A
JA
Underberg
Center for Diabetes and Endocrine Care, Ft. Lauderdale, Florida, and University of Miami Miller School of Medicine, Miami, Florida.
Paul
P
Jellinger
University of Pennsylvania Health System, Philadelphia, Pennsylvania.
Joyce
J
Ross
The Familial Hypercholesterolemia Foundation, Pasadena, California.
Katherine
K
Wilemon
D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy / Q000191:economics; D026121:Indole Alkaloids / Q000191:economics / Q000627:therapeutic use*; D000091362:PCSK9 Inhibitors; D017410:Practice Guidelines as Topic; D000071449:Proprotein Convertase 9 / Q000097:blood
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D026121:Indole Alkaloids; D000091362:PCSK9 Inhibitors; C539353:evodamine; C472125:PCSK9 protein, human; D000071449:Proprotein Convertase 9; C571059:alirocumab
Coronary Artery Disease; Familial Hypercholesterolemia; Hepatocyte; Low-Density Lipoprotein Cholesterol; Pharmacy Benefits Manager; Proprotein Convertase Subtilisin/Kexin Type 9