National Lipid Association Releases Results of Survey on Barriers to PCSK9 Inhibitor Prescription Approval Process

Last Updated: Wednesday, 24-May-2017 13:00:00 EDT

Responses from healthcare workers show significant barriers to prescriptions

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JACKSONVILLE, Fla. — The National Lipid Association (NLA) released on Wednesday the results of its survey on the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor prescription approval process.

The survey and the analysis of the findings was led by corresponding author Jerome Cohen, M.D. (Professor Emeritus, St. Louis University) and co-authored by Mark Cziraky, Pharm.D. (Research Department, HealthCore, Inc.), Terry Jacobson, M.D. (Department of Medicine, Emory University), Kevin Maki, Ph.D. (Midwest Biomedical Research, Center for Metabolic and Cardiovascular Health) and Dean Karalis, M.D. (Perelman School of Medicine, University of Pennsylvania).

Recent findings from clinical trials have shown PCSK9 therapy lowers LDL-cholesterol in addition to lowering atherosclerotic cardiovascular disease (ASCVD) events. In 2016, the NLA conducted an online survey to assess the barriers and challenges experienced in the PCSK9 inhibitor prescription approval process.

“The findings of this survey will help healthcare providers who take care of high-risk lipid patients gain approval for this new effective PCSK9 inhibitor drug class,” Cohen said. “Our findings are significant in that they showed us there are a number things that healthcare providers can do (to get PCSK9 inhibitor prescriptions approved), which is really paying close attention to documentation of the patient’s clinical history. That includes documentation of the underlying disease, ASCVD or FH, documentation of recent lipid levels and documentation of the trial of statin therapy.”

The survey, which received a response from 434 healthcare workers with extensive experience in treating patients with lipid disorders, showed healthcare providers encounter significant barriers to PCSK9 inhibitor prescriptions. According to the survey data, major barriers to approvals were insurer processes, inadequate documentation and administrative burden.

“The survey results confirm there is a common problem with denials of PCSK9 inhibitors,” Cohen said. “There are opportunities for providers to improve the initial denial rate. We’ve created a checklist based on results of the survey for healthcare providers to follow when seeking approval.”

The full manuscript can be read online in the Journal of Clinical Lipidology at



The NLA is a multidisciplinary specialty society focused on prevention of cardiovascular disease and other lipid-related disorders. The NLA’s mission is to enhance the practice of lipid management in clinical medicine, and one of its goals is to enhance efforts to reduce death and disability related to disorders of lipid metabolism in patients. Members include physicians (MDs and DOs), as well as clinical team affiliates, from an array of disciplines including PhD researchers, nurses, nurse practitioners, physician assistants, pharmacists, exercise physiologists, and dietitians.