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Low-Molecular-Weight Heparins (LMWH) for the Treatment

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Low-Molecular-Weight Heparins (LMWH) for the Treatment April 2014 1 Low-molecular-weight heparins (LMWH) for the treatment and secondary prevention of venous thromboembolism (VTE) FINAL PHARMACOECONOMICS REPORT April 2016 FINAL REPORT 2 Conflict of Interest Statement No study members report any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that may present a potential conflict of interest in the low-molecular weight heparin drug class review. Acknowledgments The Ontario Drug Policy Research Network (ODPRN) is funded by grants from the Ontario Ministry of Health and Long-term Care (MOHLTC) Health System Research Fund. Data were provided by the Institute for Clinical Evaluative Sciences (ICES), which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC). The datasets provided by ICES were linked using unique encoded identifiers and analyzed at ICES. The opinions, results and conclusions reported in this paper are those of the authors and are independent from the funding sources. No endorsement by ICES or the MOHLTC is intended or should be inferred. Study Team Pharmacoeconomics Team: Doug Coyle, Karen Lee, Mirhad Lončar, Kathryn Coyle Note Some details are censored in this report so as not to preclude publication. Publications (when available) and/or final unpublished reports will be available on the ODPRN website (www.odprn.ca). odprn.ca Ontario Drug Policy Research Network April 2016 FINAL REPORT 3 Executive Briefing This report assessed the current evidence regarding the comparative cost- effectiveness of low molecular weight heparins (LMWH) in the treatment and secondary prevention of venous thromboembolism in patients with cancer. The availability of well-conducted independent economic analyses from the Canadian perspective is currently lacking in the published literature. Three economic evaluations which addressed our research questions were identified; however, two studies received funding from the pharmaceutical industry which potentially affects the interpretation of the results. As such, a de novo model was developed focusing on the prevention of recurrent VTE in cancer patients. A de novo economic model was developed to assess the cost-effectiveness of LMWH medications compared with warfarin in the secondary prevention of cancer-related VTE. A decision tree model was developed and adapted to allow incorporation of effectiveness data from two different sources, modeling the impact of treatment over a 6-month period. In patients with cancer diagnosed with a VTE, long term prophylaxis with LMWH was not cost-effective in comparison with warfarin prophylaxis based on a commonly used threshold of $50,000 per quality-adjusted life year (QALY) gained. odprn.ca Ontario Drug Policy Research Network April 2016 FINAL REPORT 4 List of abbreviations CAD Canadian dollar CEA cost-effectiveness analysis Comparison of Low molecular weight heparin versus Oral anticoagulant CLOT Therapy for long term anticoagulation in cancer patients with venous thromboembolism (trial) CMA cost-minimization analysis CUA cost-utility analysis DC Doug Coyle DVT deep vein thrombosis HCP health care payer ICER incremental cost-effectiveness ratio INR international normalized ratio IU International Unit LMWH Low-molecular-weight heparin ML Mirhad Lončar PE pulmonary embolism QALY quality-adjusted life year RCT randomized controlled trial USA United States USD US dollar VTE venous thromboembolism odprn.ca Ontario Drug Policy Research Network April 2016 FINAL REPORT 5 Contents Conflict of Interest Statement ................................................................................................. 2 Acknowledgments ................................................................................................................... 2 Study Team ............................................................................................................................. 2 Note ......................................................................................................................................... 2 List of Exhibits ......................................................................................................................... 7 Executive Summary ................................................................................................................ 8 Research Questions ............................................................................................................ 8 Systematic Review of Published Economic Evaluations .................................................... 8 De novo Economic Evaluation ............................................................................................ 9 Appendices ............................................................................................................................... 10 Appendix A – Systematic Review of Economic Evidence........................................................ 10 Research Questions ............................................................................................................. 10 Review of Published Literature ............................................................................................. 10 Search Strategy and Search Findings .............................................................................. 10 Summary and Critical Appraisal of Included Studies ........................................................ 11 Canadian Studies .............................................................................................................. 12 Non-Canadian Studies ...................................................................................................... 13 Overall Conclusions .......................................................................................................... 14 Appendix A1: Search Strategy .............................................................................................. 15 Appendix A2: Results of Search ........................................................................................... 19 Appendix A3: List of Excluded Studies ................................................................................. 20 Appendix A4: List of Included Studies .................................................................................. 23 Appendix A5: Characteristics of Reviewed Studies ............................................................. 24 Appendix B – De novo Economic Evaluation ........................................................................... 26 Research Question ............................................................................................................... 26 Study Objectives ................................................................................................................... 26 Background ........................................................................................................................... 26 Economic Evaluation ............................................................................................................ 27 Clinical Parameters ........................................................................................................... 27 Model Structure ................................................................................................................. 28 Data Inputs ........................................................................................................................ 29 Utilities ............................................................................................................................... 29 Resource Use and Costs .................................................................................................. 30 Cost Effectiveness ............................................................................................................. 31 odprn.ca Ontario Drug Policy Research Network April 2016 FINAL REPORT 6 Deterministic Sensitivity Analyses .................................................................................... 31 Probabilistic Sensitivity Analyses ...................................................................................... 33 Findings ................................................................................................................................. 33 Base Case ......................................................................................................................... 33 Deterministic Sensitivity Analysis ...................................................................................... 35 Probabilistic Sensitivity Analysis ....................................................................................... 37 Overall Summary ............................................................................................................... 40 Conclusions ........................................................................................................................... 41 Appendix B1: Data Estimates ............................................................................................... 42 References ............................................................................................................................... 45 odprn.ca Ontario Drug Policy Research Network April 2016 FINAL REPORT 7 List of Exhibits Exhibit 1: Flow diagram of the selection process for potentially relevant studies. ................... 19 Exhibit 2: List
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