Author + information
- Received July 2, 2014
- Revision received September 28, 2014
- Accepted November 4, 2014
- Published online February 10, 2015.
- Patricia A. Cowper, PhD∗∗ (, )
- Wenqin Pan, PhD∗,
- Kevin J. Anstrom, PhD∗,
- Padma Kaul, PhD†,
- Lars Wallentin, MD, PhD‡,
- Linda Davidson-Ray, MA∗,
- Elisabet Nikolic, MSc§,
- Magnus Janzon, MD, PhD‖,
- Lars-Åke Levin, PhD§,
- Christopher P. Cannon, MD¶,
- Robert A. Harrington, MD# and
- Daniel B. Mark, MD, MPH∗
- ∗Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
- †Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
- ‡Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden
- §Center for Medical Technology Assessment and Department of Medicine and Health Sciences, Linköping University, Linköping, Sweden
- ‖Department of Cardiology and Department of Medicine and Health Sciences, Linköping University, Linköping, Sweden
- ¶Thrombolysis In Myocardial Infarction Study Group, Brigham and Women’s Hospital, Boston, Massachusetts
- #Department of Medicine, Stanford University, Stanford, California
- ↵∗Reprint requests and correspondence:
Dr. Patricia A. Cowper, Duke Clinical Research Institute, PO Box 17969, Durham, North Carolina 27715.
Background Based on results of the PLATO (Platelet Inhibition and Patient Outcomes) trial comparing ticagrelor with clopidogrel therapy, the U.S. Food and Drug Administration approved ticagrelor in 2011 for reducing thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) with the proviso that it be taken with low-dose aspirin.
Objectives This study sought to assess the cost and cost effectiveness of ticagrelor therapy relative to clopidogrel in treating ACS patients from the perspective of the U.S. health care system.
Methods We estimated within-trial resource use and costs using U.S. low-dose aspirin patients in PLATO (n = 547). Quality-adjusted life expectancy was estimated using the total PLATO population (n = 18,624), combined with baseline risk and long-term survival data from an external ACS patient cohort. Study drugs were valued at current costs. Cost effectiveness was assessed, as was the sensitivity of results to sampling and methodological uncertainties.
Results One year of ticagrelor therapy, relative to that of generic clopidogrel, cost $29,665/quality-adjusted life-year gained, with 99% of bootstrap estimates falling under a $100,000 willingness-to-pay threshold. Results were robust to extensive sensitivity analyses, including variations in clopidogrel cost, exclusion of costs in extended years of life, and a recalibrated estimate of survival reflecting a lower underlying mortality risk in the United States.
Conclusions For PLATO-eligible ACS patients, a U.S. perspective comparison of the current standard of dual antiplatelet therapy of aspirin with clopidogrel versus aspirin plus ticagrelor showed that the ticagrelor regimen increased life expectancy at an incremental cost well within accepted benchmarks of good value for money. (A Comparison of Ticagrelor [AZD6140] and Clopidogrel in Patients With Acute Coronary Syndrome [PLATO]; NCT00391872)
This study was supported by AstraZeneca through a research grant to Linköping University, with a subcontract to the Duke Clinical Research Institute. The sponsor was asked to provide feedback regarding the U.S. economic substudy design, results, and manuscript; however, all final decisions regarding the publication and its contents were made independently of sponsor by coauthors. Dr. Cowper has received research support from AstraZeneca, Eli Lilly & Co., Bristol-Myers Squibb/Pfizer, and AGA Medical. Drs. Pan and Kaul have received research support from AstraZeneca and Eli Lilly & Co. Dr. Anstrom has received research support from AstraZeneca, Eli Lilly & Co., and Medtronic; consulted for Abbott Vascular, AstraZeneca, Bristol-Myers Squibb, Gilead, Pfizer, GlaxoSmithKline, Promedior, and Ikaria; served on data monitoring committees for Forest, GlaxoSmithKline, Pfizer, and Vertex; and holds equity interest in Biscardia. Dr. Wallentin has received research grants from AstraZeneca, Merck & Co., Boehringer-Ingelheim, Bristol-Myers Squibb/Pfizer, and GlaxoSmithKline; consulted for Abbott, Merck & Co., Regado Biosciences, Athera Biotechnologies, Boehringer-Ingelheim, AstraZeneca, GlaxoSmithKline, and Bristol-Myers Squibb/Pfizer; received lecture fees from AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb/Pfizer, and GlaxoSmithKline; and honoraria from AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb/Pfizer, and GlaxoSmithKline; and travel support from AstraZeneca, Bristol-Myers Squibb/Pfizer and GlaxoSmithKline. Dr. Janzon has received lecture fees from AstraZeneca and Pfizer; and participated on the scientific advisory board for AstraZeneca. Dr. Levin has received financial support for lectures, advisory board participation, and research from AstraZeneca, Bayer, Boehringer-Ingelheim, Pfizer, and St. Jude Medical. Ms. Davidson-Ray has received research support from AstraZeneca, Eli Lilly & Co., Gilead, Bristol-Myers Squibb, and AGA Medical. Dr. Cannon has received research grants and support from Accumetrics, Arisaph, AstraZeneca, Boehringer-Ingelheim, CSL Behring, Essentialis, GlaxoSmithKline, Janssen, Merck & Co., Regeneron, Sanofi, and Takeda; and served on advisory boards for Bristol-Myers Squibb, Lipimedix, and Pfizer. Dr. Harrington has received advisory board member fees from Baxter, Bristol-Myers Squibb, CSL Behring, Daiichi-Sankyo, Gilead, Johnson & Johnson, The Medicines Company, Medtronic, Merck & Co., and WebMD; grants from AstraZeneca, Bristol-Myers Squibb, The Medicines Company, Merck & Co., and Portola Pharmaceuticals; and holds ownership interests in Adverse Events and Myokardia. Dr. Mark has received grant funding from AstraZeneca, Gilead, Eli Lilly & Co., Bristol-Myers Squibb, and AGA Medical; and consulting fees from Janssen, Medtronic, and Somahlution. Ms. Nikolic has reported no relationships relevant to the contents of this paper to disclose.
- Received July 2, 2014.
- Revision received September 28, 2014.
- Accepted November 4, 2014.
- American College of Cardiology Foundation