Dhruv S. Kazi, MD, MSc, MS; Joanne Penko, MS, MPH; Pamela G. Coxson, PhD; David Guzman, MSPH; Pengxiao C. Wei, BS, MPH; Kirsten Bibbins-Domingo, PhD, MD, MAS
Disclaimer: The Framingham Cohort and Framingham Offspring Research Materials were obtained from the U.S. National Heart, Lung, and Blood Institute (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center. The manuscript does not necessarily reflect the opinions or views of the Framingham Cohort, Framingham Offspring, or NHLBI.
Financial Support: By the University of California, San Francisco, and the Institute for Clinical and Economic Review.
Disclosures: Drs. Kazi and Coxson and Ms. Penko report grants from the Institute for Clinical and Economic Review during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-1776.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Proctor & Gamble, Pfizer, and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Not available. Statistical code: The Cardiovascular Disease Policy Model is available to interested readers who submit a 1- to 2-page research proposal and collaboration plan to Dr. Bibbins-Domingo (e-mail, firstname.lastname@example.org) and sign the Creative Commons agreement available at http://tiny.ucsf.edu/CVDpolicymodel, pending approval by the model team. Data set: Data for this study come from sources detailed in the Supplement. Data from the Framingham Heart Study are available following approval of research applications submitted at http://biolincc.nhlbi.nih.gov/studies/framcohort/?q=framingham for the Framingham Heart Study cohort and http://biolincc.nhlbi.nih.gov/studies/framoffspring/?q=framingham for the Framingham Offspring Study. Data on the health survey, vital statistics, and health care costs are publicly available from government sources described in the Supplement.
Corresponding Author: Kirsten Bibbins-Domingo, PhD, MD, MAS, Department of Epidemiology and Biostatistics, University of California, San Francisco, 55 016th Street, 2nd Floor, Box 0560, San Francisco, CA 94143; e-mail, Kirsten.Bibbins-Domingo@ucsf.edu.
Current Author Addresses: Dr. Kazi: Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, 375 Longwood Avenue, 4th Floor, Boston, MA 02215.
Ms. Penko, Drs. Coxson and Bibbins-Domingo, and Ms. Wei: Department of Epidemiology and Biostatistics, University of California, San Francisco, 55 016th Street, 2nd Floor, Box 0560, San Francisco, CA 94143.
Mr. Guzman: UCSF Center for Vulnerable Populations, 1001 Potrero Avenue, Building 10, W13, UCSF-ZSFGH Box 1364, San Francisco, CA 94110.
Author Contributions: Conception and design: D.S. Kazi, J. Penko, K. Bibbins-Domingo.
Analysis and interpretation of the data: D.S. Kazi, J. Penko, P.G. Coxson, D. Guzman, P.C. Wei, K. Bibbins-Domingo.
Drafting of the article: D.S. Kazi, K. Bibbins-Domingo.
Critical revision for important intellectual content: D.S. Kazi, J. Penko, K. Bibbins-Domingo.
Final approval of the article: D.S. Kazi, J. Penko, P.G. Coxson, D. Guzman, P.C. Wei, K. Bibbins-Domingo.
Provision of study materials or patients: D.S. Kazi, K. Bibbins-Domingo.
Statistical expertise: D.S. Kazi, K. Bibbins-Domingo.
Obtaining of funding: D.S. Kazi, K. Bibbins-Domingo.
Administrative, technical, or logistic support: J. Penko, P.C. Wei, K. Bibbins-Domingo.
Collection and assembly of data: D.S. Kazi, P.G. Coxson, K. Bibbins-Domingo.
The ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial included participants with a recent acute coronary syndrome. Compared with participants receiving statins alone, those receiving a statin plus alirocumab had lower rates of a composite outcome including myocardial infarction (MI), stroke, and death.
To determine the cost-effectiveness of alirocumab in these circumstances.
Decision analysis using the Cardiovascular Disease Policy Model.
Data sources representative of the United States combined with data from the ODYSSEY Outcomes trial.
U.S. adults with a recent first MI and a baseline low-density lipoprotein cholesterol level of 1.81 mmol/L (70 mg/dL) or greater.
U.S. health system.
Alirocumab or ezetimibe added to statin therapy.
Incremental cost-effectiveness ratio in 2018 U.S. dollars per quality-adjusted life-year (QALY) gained.
Compared with a statin alone, the addition of ezetimibe cost $81 000 (95% uncertainty interval [UI], $51 000 to $215 000) per QALY. Compared with a statin alone, the addition of alirocumab cost $308 000 (UI, $197 000 to $678 000) per QALY. Compared with the combination of statin and ezetimibe, replacing ezetimibe with alirocumab cost $997 000 (UI, $254 000 to dominated) per QALY.
The price of alirocumab would have to decrease from its original cost of $14 560 to $1974 annually to be cost-effective relative to ezetimibe.
Effectiveness estimates were based on a single randomized trial with a median follow-up of 2.8 years and should not be extrapolated to patients with stable coronary heart disease.
The price of alirocumab would have to be reduced considerably to be cost-effective. Because substantial reductions already have occurred, we believe that timely, independent cost-effectiveness analyses can inform clinical and policy discussions of new drugs as they enter the market.
University of California, San Francisco, and Institute for Clinical and Economic Review.
Kazi DS, Penko J, Coxson PG, Guzman D, Wei PC, Bibbins-Domingo K. Cost-Effectiveness of Alirocumab: A Just-in-Time Analysis Based on the ODYSSEY Outcomes Trial. Ann Intern Med. [Epub ahead of print 1 January 2019]170:221–229. doi: 10.7326/M18-1776
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Published: Ann Intern Med. 2019;170(4):221-229.
Published at www.annals.org on 1 January 2019
Cardiology, Coronary Risk Factors, Dyslipidemia, Healthcare Delivery and Policy, High Value Care.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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