MedicalResearch.com Interview with:
Gregg C. Fonarow, MD, FACC, FAHA
Eliot Corday Professor of Cardiovascular Medicine and Science
Director, Ahmanson-UCLA Cardiomyopathy Center
Co-Chief of Clinical Cardiology, UCLA Division of Cardiology
Co-Director, UCLA Preventative Cardiology Program
David Geffen School of Medicine at UCLA
Los Angeles, CA
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The study identifies the clinical and economic consequences of treating a population of patients with established atherosclerotic cardiovascular disease (ASCVD ) at high-risk of cardiovascular (CV) events and defines the cost-effectiveness of the PCSK-9 inhibitor evolocumab under various clinical scenarios. The analysis is based on the clinical outcomes from the Repatha Outcomes Study (FOURIER) in patients with established atherosclerotic cardiovascular disease (ASCVD), such as those who have already had a heart attack or stroke who require additional therapy.
This is the first cost-effectiveness assessment of evolocumab using a model based on a high-quality outcomes trial, combined with U.S. clinical practice data. The analysis identifies the types of high-risk patients for whom this therapy is both clinically beneficial and cost-effective. This study utilized cost-effectiveness and value thresholds employed by the World Health Organization and the American College of Cardiology/American Heart Association.
Evolocumab was found to exceed generally accepted cost-effectiveness thresholds at current list price. However, this medication could be a cost-effective treatment for patients with established ASCVD in the U.S. when the net price is at or below $9,669 per year.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: In patients with established ASCVD who, with other currently available lipid-modifying therapies including maximally tolerated statins, require additional LDL-cholesterol lowering, adding evolocumab could facilitate improved clinical outcomes for a considerable proportion of patients. Substantial population health improvements and further progress towards reduction in non-communicable diseases could result.
Yet, there has been much debate about the cost and value of PCSK 9 inhibitors. This study helps better identify value based prices for these agents and the specific high-risk patients who have had a heart attack or stroke with high LDL levels despite maximally-tolerated statin therapy where there are both clinical benefits and economic value of providing evolocumab therapy.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: As additional clinical trials and longer-term follow-up data become available, these economic models can be further refined.
This analysis is only applicable to US patients with established ASCVD and is not generalizable to primary prevention patients, other populations at lower cardiovascular event risk, or patients outside the US. Further studies are needed to evaluate the cost-effectiveness in other countries and in other patient populations.
MedicalResearch.com: Is there anything else you would like to add?
Response: Targeting a subset of patients with ASCVD that are at particularly high risk for events based on clinical factors, using formal risk scores, or use of a higher LDL-cholesterol treatment initiation threshold for the addition of evolocumab therapy would be alternative approaches to improve value and limit expenditures.
Study was funded by Amgen. I and other study authors have served as consultants to Amgen
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Fonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, van Hout B, Villa G, Qian Y, Somaratne R, Sabatine MS. Cost-effectiveness of Evolocumab Therapy for Reducing Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. Published online August 23, 2017. doi:10.1001/jamacardio.2017.2762
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