Canadian Agency for Agence canadienne Drugs and Technologies des médicaments et des in Health technologies de la santé CADTH Technology Report Issue 131 Clopidogrel Compared with Other Antiplatelet November 2010 Agents for Secondary Prevention of Vascular Events in Adults Undergoing Percutaneous Coronary Intervention: Clinical and Cost-Effectiveness Analyses Supporting Informed Decisions Until April 2006, the Canadian Agency for Drugs and Technologies in Health (CADTH) was known as the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Publications can be requested from: CADTH 600-865 Carling Avenue Ottawa ON Canada K1S 5S8 Tel: 613-226-2553 Fax: 613-226-5392 Email: [email protected] or downloaded from CADTH’s website: http://www.cadth.ca Cite as: Chen SY, Russell E, Banerjee S, Hutton B, Brown A, Asakawa K, McGahan L, Clark M, Severn M, Cox J, Sharma M. Clopidogrel Compared with Other Antiplatelet Agents for Secondary Prevention of Vascular Events in Adults Undergoing Percutaneous Coronary Intervention: Clinical and Cost-Effectiveness Analyses [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2010 (Technology report; no. 131). [cited 2010-11-01]. Available from: http://www.cadth.ca/preview.php/en/publication/2708 Production of this report is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan, and Yukon. The Canadian Agency for Drugs and Technologies in Health takes sole responsibility for the final form and content of this report. The views expressed herein do not necessarily represent the views of Health Canada or any provincial or territorial government. 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External Reviewers John Eikelboom, MBBS John A. Cairns, MD, FRCPC Associate Professor Professor of Medicine McMaster University University of British Columbia Hamilton, ON Vancouver, BC Chris Skedgel, MDE Carlo Marra, PharmD, PhD Research Health Economist Associate Professor Department of Medicine Faculty of Pharmaceutical Sciences Dalhousie University University of British Columbia Halifax, NS Vancouver, BC George Wells, MSc, PhD Professor Department of Epidemiology and Community Medicine University of Ottawa Ottawa, ON CADTH Peer Review Group Reviewers Rick Audas, BBA, MBA, MA(econ), PhD Assistant Professor Memorial University St. John’s, NL Industry The following manufacturers were provided with an opportunity to comment on an earlier version of this report: Boehringer Ingelheim (Canada) Ltd., Bayer Inc., Sanofi-aventis Canada Inc., and Hoffmann-La Roche Ltd. All comments that were received were considered when preparing the final report. This report is a review of existing public literature, studies, materials, and other information and documentation (collectively the “source documentation”) that are available to CADTH. The accuracy of the contents of the source documentation on which this report is based is not warranted, assured, or represented in any way by CADTH, and CADTH does not assume responsibility for the quality, propriety, inaccuracies, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH takes sole responsibility for the final form and content of this report. The statements and conclusions in this report are those of CADTH and not of its Panel members or reviewers. i Clopidogrel Compared with Other Antiplatelet Agents for Secondary Prevention of Vascular Events in Adults Undergoing Percutaneous Coronary Intervention: Clinical and Cost-Effectiveness Analyses Authorship Stella Yue Chen led the research, selected articles, extracted data, and performed standard meta- analyses; she also wrote sections of the clinical review and contributed to revisions. Erin Russell led the research on the economic section, extracted data for the economic review, performed quality assessment of economic studies, wrote the economic review, performed the primary economic analyses, wrote the economic evaluation section, performed the population and budget impact analyses, wrote the population and budget impact sections, and contributed to revisions of the draft. Srabani Banerjee contributed to protocol development, selected articles, extracted data, and contributed to drafting the report and revisions. Brian Hutton extracted data, performed mixed treatment comparison meta-analyses, wrote sections of the clinical review, examined the set-up of the economic model, and contributed to revisions. Allan Brown wrote the protocol, developed criteria for the selection of economic evaluations for review, selected articles for inclusion in the economic evaluations, reviewed data extractions and quality assessments, provided advice on the quality assessment process, and reviewed and provided advice for the drafts. Keiko Asakawa assisted in article selection for the economic review, performed quality assessment of the selected economic articles, contributed to budget impact analyses, and contributed to revisions of the draft. Lynda McGahan selected articles, extracted data, wrote the guidelines section, and contributed to revisions. Michelle Clark performed article selection, created data extraction tables, and contributed to formatting and review of the report. Melissa Severn performed some of the literature searches, wrote the literature search methods section and the associated appendices, checked references, and contributed to the revisions. Jafna Cox contributed to the planning of the report, provided direction and clinical insight as required throughout the process, wrote the ethics and psychosocial sections, and critically reviewed the drafts. Mukul Sharma was associated in planning the focus, scope, and operations of the review; commented on analysis and interpretation of data; and critically reviewed and edited the drafts. All authors approved the final report. Clopidogrel Compared with Other Antiplatelet Agents for Secondary Prevention of Vascular Events ii in Adults Undergoing Percutaneous Coronary Intervention: Clinical and Cost-Effectiveness Analyses Acknowledgments The team thanks Elise Cogo for the development and performance of the literature search; Dr. Doug Coyle for advice on design, conduct, and reporting of economic evaluations; and Eva Tsakonas for data extraction and quality assessment of observational studies and guidelines. Conflicts of Interest John Eikelboom has received grants or honoraria from Sanofi-aventis, Bristol-Myers Squibb, Portola, Eli Lilly, and AstraZeneca. Dr. Jafna Cox received funding from Bristol-Myers Squibb and Sanofi-aventis for research support. He has received honoraria for talks from Sanofi-aventis and Bristol-Myers Squibb (among others), and he has participated in the development of accredited continuing medical education activities that were sponsored by pharmaceutical companies and their advisory boards. Dr. Mukul Sharma has received support for speaking engagements and travel; and honoraria as an advisory board member, from Bristol-Myers Squibb, Sanofi-aventis, and Boehringer Ingelheim (Canada) Ltd. iii Clopidogrel Compared with Other Antiplatelet Agents for Secondary Prevention of Vascular Events in Adults Undergoing Percutaneous Coronary Intervention: Clinical and Cost-Effectiveness Analyses EXECUTIVE SUMMARY The Issue Approximately 5.7% of Canadians have cardiovascular disease (CVD). In 2005, 31% of deaths in Canada were due to CVD. In 2006, the estimated total drug cost of CVD in Canada was $5.3 billion (increased by more than 200% from $1.7 billion in 1996). Clopidogrel, which is used to prevent atherothrombotic events, is a more costly drug than other treatment options, and the number of reimbursement requests for clopidogrel submitted to Canadian publicly funded drug plans is increasing. The generic version of clopidogrel will be available in 2012. Objectives The aim of this report is to compare clopidogrel with other antiplatelet agents for the secondary prevention of vascular events in adults undergoing percutaneous coronary intervention (PCI). This objective will be accomplished by addressing four research questions.