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Recombinant Activated Factor VII for Prevention of Bleeding Unrelated to Hemophilia: Clinical and Economic Systematic Review [Internet]

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Recombinant Activated Factor VII for Prevention of Bleeding Unrelated to Hemophilia: Clinical and Economic Systematic Review [Internet] Canadian Agency for Agence canadienne Drugs and Technologies des médicaments et des in Health technologies de la santé technology report Recombinant Activated Factor VII for HTA Prevention of Bleeding Unrelated to Issue 124 Hemophilia: Clinical and Economic February 2010 Systematic Review www.cadth.ca www.acmts.ca Printed in Canada 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: Murphy G, Tsakonas E, Ndegwa S, Anderson D, Barkun J, Mierzwinski-Urban M. Recombinant Activated Factor VII for Prevention of Bleeding Unrelated to Hemophilia: Clinical and Economic Systematic Review [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2010. (Technology Report; no. 124). [cited 2010 Feb 4]. Available from: http://www.cadth.ca/index.php/en/publication/960 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. Reproduction of this document for non-commercial purposes is permitted provided appropriate credit is given to CADTH. CADTH is funded by Canadian federal, provincial, and territorial governments. Legal Deposit – 2010 National Library of Canada ISBN: 978-1-926680-36-1 (print) ISBN: 978-1-926680-37-8 (online) H0457B – February 2010 PUBLICATIONS MAIL AGREEMENT NO. 40026386 RETURN UNDELIVERABLE CANADIAN ADDRESSES TO CANADIAN AGENCY FOR DRUGS AND TECHNOLOGIES IN HEALTH 600-865 CARLING AVENUE OTTAWA ON K1S 5S8 Canadian Agency for Drugs and Technologies in Health Recombinant Activated Factor VII for Prevention of Bleeding Unrelated to Hemophilia: Clinical and Economic Systematic Review Gaetanne Murphy, BSc Pharm1 Eva Tsakonas, BA MSc2 Sarah Ndegwa, BSc Pharm MSc1 David Anderson, MD FRCPC3 Jeffrey Barkun, MD MSc FRCPC4 Monika Mierzwinski-Urban, MLIS1 February 2010 1 Canadian Agency for Drugs and Technologies in Health, Ottawa, ON 2 Independent Consultant 3 Division of Hematology, Department of Medicine, Pathology and Community Health and Epidemiology, Dalhousie University, Halifax, NS 4 Division of General Surgery, McGill University, Montreal, QC Reviewers These individuals kindly provided comments on this report. External Reviewers Craig Mitton, PhD Man-Chiu Poon, MD MSc FRCPC FACP Associate Professor Professor of Medicine, Pediatrics and Oncology, University of British Columbia University of Calgary Vancouver, BC Director, Southern Alberta Rare Blood and Bleeding Disorders Comprehensive Care Program, Alberta Health Services Calgary, AB Richard Audas, BBA MBA MA PhD Peter Ghali, MD FRCPC MSc(Epi) Assistant Professor Assistant Professor Faculty of Medicine, McGill University Health Centre Memorial University Montreal, QC St. John’s, NL Brian Muirhead, MD FRCPC University of Manitoba Winnipeg, MB CADTH Peer Review Group Reviewers Jocalyn Clark, BSc MSc PhD Stuart Peacock, DPhil Assistant Professor of Medicine, Co-Director University of Toronto National Centre for Health Economics, Services, Senior Editor Policy and Ethics in Cancer PLoS Medicine Vancouver, BC Toronto, ON Industry: Novo Nordisk Canada Inc. was provided with an opportunity to comment on an earlier version of this 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 Recombinant Activated Factor VII for Prevention of Bleeding Unrelated to Hemophilia: Clinical and Economic Systematic Review Authorship Gaetanne Murphy, research lead for the project, led the protocol development and clinical review, wrote the clinical draft, revised the report, and prepared the report for publication. Eva Tsakonas led the economic review, designed the economic portion of the protocol, and wrote the health services impact and economic sections of the report. She revised the report and prepared it for publication. Sarah Ndegwa provided guidance on the protocol development and drafting of the report. She assisted with abstract screening, assisted with extracting and verifying data, and reviewed drafts for clarity and accuracy. David Anderson and Jeffrey Barkun provided clinical expertise and guidance on protocol development, interpretation of evidence, drafting of the report, and revision of the report. Monika Mierzwinski-Urban developed the literature search strategies, performed the literature searches, provided updates to the searches, wrote the literature search methods section, verified references, and formatted the bibliographies. Acknowledgements The authors are grateful to Sheri Pohar, who provided background information for the protocol and the introduction, and to Hussein Noorani, who wrote the ethics section. We thank Melissa Severn for completing the final verification of references and formatting the bibliography. Conflicts of Interest None of the co-authors has any conflicts of interest to declare. Dr. Man-Chiu Poon was a member of the Expert Panel for Glanzmann’s Thrombasthenia Registry, sponsored by Novo Nordisk, and received honorariums from Novo Nordisk in 2006 and 2009. He was also a speaker on “Management of bleeding in congenital platelet disorders” at the Asian Regional Hemostasis Update Meeting (July 2008) sponsored by the Thai Society of Hematology and International Hemophilia Training Center in Bangkok (received honorarium provided by Novo Nordisk). Dr. Man-Chiu Poon was also a speaker on “Management of patients with refractory platelet function disorders” at the 3rd Asian Regional Hemostasis Update meeting (April 18 to 19, 2009) sponsored by the Malaysian Society of Hematology and the Malaysian Society of Transfusion Medicine in Kuala Lumpur (received honorarium provided by Novo Nordisk). Dr. Brian Muirhead has received honorariums from Novo Nordisk, Fresenius Kobe, Bristol- Myers Squibb, and Bayer. Recombinant Activated Factor VII for Prevention of Bleeding Unrelated to Hemophilia: ii Clinical and Economic Systematic Review iii Recombinant Activated Factor VII for Prevention of Bleeding Unrelated to Hemophilia: Clinical and Economic Systematic Review EXECUTIVE SUMMARY The Issue Recombinant activated factor VII (rFVIIa) is a hemostatic agent that is approved for the treatment of bleeding episodes in hemophilia A or B patients with clotting factor inhibitors. It is being used beyond the approved indications by non-hemophilia patients undergoing surgery. Recombinant FVIIa is costly, and it is unclear if the benefit of the off-label use of rFVIIa outweighs the potential harms and costs. Objectives This report assesses the impact of using rFVIIa for the prevention of bleeding in patients without hemophilia or other inherited bleeding disorders. The research questions are: 1. What is the clinical effectiveness of evaluated doses and regimens of rFVIIa compared with placebo, no treatment, or other standard therapies for the prevention of bleeding associated with liver transplantation, prostatectomy, cardiac surgery, or supra-therapeutic anticoagulation in individuals without hemophilia, inherited platelet disorders, or other coagulopathies? 2. What are the practice guidelines for monitoring safety and efficacy of rFVIIa when used for the prevention of bleeding associated with liver transplantation, prostatectomy, cardiac surgery, or supra-therapeutic anticoagulation in individuals without hemophilia, inherited platelet disorders, or other coagulopathies? 3. What is the cost-effectiveness of rFVIIa compared with placebo, no treatment, or other standard therapies when used for liver transplantation, prostatectomy, cardiac surgery, or supra-therapeutic anticoagulation in individuals without hemophilia, inherited platelet disorders, or other coagulopathies? Methods A systematic review of the clinical and economic literature was conducted. Randomized controlled trials (RCTs), non-randomized controlled clinical trials, prospective controlled observational studies, evidence based guidelines, and economic analyses that met the inclusion criteria were included in the review. The selection of studies and extraction of data were completed independently by two researchers. Clinical Effectiveness Eight RCTs and two cohort studies focused on surgical patients who received rFVIIa, placebo, or usual care for the prevention of bleeding. No studies evaluated rFVIIa for the prevention
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