MedicalResearch.com Interview with:
Julia M. Akeroyd, MPH
Center for Innovations in Quality, Effectiveness, and Safety (IQuESt)
Michael E. DeBakey Veteran Affairs Medical Center
Salim S Virani, MBBS, Ph.D.
Baylor College of Medicine
MedicalResearch.com: What is the background for this study?
Response: In the recently published Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial, treatment with evolocumab resulted in a 15% relative (1.5% absolute) risk reduction of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD) at a median follow-up of 2.2 years. Given the high cost of evolocumab, there is a need to identify what proportion of ASCVD patients would qualify for evolocumab based on FOURIER entry criteria and how eligibility would change if maximal doses of evidence-based lipid lowering therapies were required.
MedicalResearch.com: What are the main findings?
Response: The main findings of this study indicate that approximately one-fourth of U.S. Veterans aged 40-85 with ASCVD would qualify for evolocumab using FOURIER trial criteria. However, approximately half of eligible patients are not receiving high-intensity statins. Uptitration of standard therapy could lead to significant cost savings by decreasing eligibility for evolocumab by approximately 20% with high-intensity statins, by 50% with addition of ezetimibe, or by approximately 60% with combination of high-intensity statins and ezetimibe. Restricting evolucumab to patients with LDL-C >70 mg/dL after accounting for cost associated with titration to high-intensity statin plus ezetimibe would be expected to result in an annual net cost savings of $1.02 – $1.13 billion per year. Furthermore, roughly 40% of the patients had poor statin adherence. Improving statin adherence would further lower LDL-C levels in these patients, improve cardiovascular outcomes and reduce the cost of expensive add on therapies.
MedicalResearch.com: What should readers take away from your report?
Response: Health care systems have considerable opportunity to increase use of evidence-based high-intensity statins and ezetimibe which may reduce the need for additional costly therapies such as evolocumab. In addition, system-level interventions aimed at improving adherence will further improve cardiovascular outcomes in these patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The reasons for current undertreatment with evidence-based lipid lowering therapies may include patient preference, statin intolerance, or provider clinical inertia. Thus, research aimed at understanding and targeting these reasons is needed. Additionally, the achieved LDL-C levels using statin and ezetimibe titration strategies are still higher than the median LDL-C of 30mg/dL achieved with evolocumab in the FOURIER trial. The impact of these LDL-C differences below 70 mg/dL requires further study.
Disclosures are provided in the manuscript
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Estimation of Eligibility for PCSK9 Inhibitors and Associated Costs Based on the FOURIER Trial: Insights from the Department of Veterans Affairs
Salim S. Virani, Julia M. Akeroyd, Vijay Nambi, Paul A. Heidenreich, Pamela B. Morris, Khurram Nasir, Erin D. Michos, Vera A. Bittner, Laura A. Petersen, Christie M. Ballantyne
Originally published May 2, 2017
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