To assist decision-makers considering implementation or reassessment of factor V Leiden (FVL) and prothrombin gene (PG) mutation testing practices, CADTH’s Health Technology Expert Review Panel (HTERP) developed evidence-informed guidance on the optimal use of these tests for patients with unprovoked venous thromboembolism (VTE). The clinical and economic evidence used for developing guidance was derived from the following CADTH report:

• The CADTH Optimal Use report: Effectiveness of Factor V Leiden and Prothrombin Mutation Testing in Patients Presenting with Unprovoked First Thromboembolic Episode, consisting of a systematic review of the clinical evidence and an economic analysis.

HTERP considered the evidence and its limitations from a population-based perspective.

Contents

• 1. GUIDANCE
• 2. BACKGROUND
• 3. SUMMARY OF THE EVIDENCE
  • 3.1 Clinical Evidence
  • 3.2 Economic Evidence
• REFERENCES
• APPENDIX 1 HEALTH TECHNOLOGY EXPERT REVIEW PANEL (HTERP)
• APPENDIX 2 ABBREVIATIONS

Suggested citation:

Canadian Agency for Drugs and Technologies in Health. Guidance on the use of factor V Leiden and prothrombin mutation testing in patients with a first unprovoked thromboembolic episode [Internet]. Ottawa: The Agency; 2015 Mar. (CADTH Optimal Use Report vol.4, no.1b). [cited yyyy mmm dd]. Available from: http://www.cadth.ca/media/pdf/OP0517_Thrombophilia_Recs_Report.pdf

This report is prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). This report contains a comprehensive review of existing public literature, studies, materials, and other information and documentation (collectively the “source documentation”) available to CADTH at the time it was prepared, and it was guided by expert input and advice throughout its preparation.

The information in this report is intended to help health care decision-makers, patients, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment in respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice.

While CADTH has taken care in the preparation of this report to ensure that its contents are accurate, complete, and up-to-date, CADTH does not make any guarantee to that effect. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or as a result of the use (or misuse) of any information contained in or implied by the information in this report.

CADTH takes sole responsibility for the final form and content of this report. The statements, conclusions, and views expressed herein do not necessarily represent the view of Health Canada or any provincial or territorial government.

Production of this report is made possible through a financial contribution from Health Canada.