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Selected Treatments for Varicose Veins Final Evidence Report

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Selected Treatments for Varicose Veins Final Evidence Report Selected treatments for varicose veins Final evidence report April 14, 2017 Health Technology Assessment Program (HTA) Washington State Health Care Authority PO Box 42712 Olympia, WA 98504-2712 (360) 725-5126 www.hca.wa.gov/about-hca/health-technology-assessment [email protected] Selected Treatments for Varicose Veins A Health Technology Assessment Prepared for Washington State Health Care Authority Final REPORT April 14, 2017 Acknowledgement This report was prepared by: Hayes, Inc. 157 S. Broad Street Suite 200 Lansdale, PA 19446 P: 215.855.0615 F: 215.855.5218 This report is intended to provide research assistance and general information only. It is not intended to be used as the sole basis for determining coverage policy or defining treatment protocols or medical modalities, nor should it be construed as providing medical advice regarding treatment of an individual’s specific case. Any decision regarding claims eligibility or benefits, or acquisition or use of a health technology is solely within the discretion of your organization. Hayes, Inc. assumes no responsibility or liability for such decisions. Hayes employees and contractors do not have material, professional, familial, or financial affiliations that create actual or potential conflicts of interest related to the preparation of this report. WA – Health Technology Assessment April 14, 2017 Table of Contents EVIDENCE SUMMARY ......................................................................................................................... 1 Summary of Clinical Background ........................................................................................................ 1 Varicose Veins ....................................................................................................................................... 1 Endovascular Laser Ablation ................................................................................................................. 2 Radiofrequency Ablation ...................................................................................................................... 2 Sclerotherapy ........................................................................................................................................ 3 Ambulatory Phlebectomy ..................................................................................................................... 3 Vein Ligation and Stripping ................................................................................................................... 4 Policy Context .................................................................................................................................... 4 Summary of Review Objectives .......................................................................................................... 4 Review Objectives ................................................................................................................................. 4 Key Questions ....................................................................................................................................... 5 Methods ............................................................................................................................................ 6 Search Strategy and Selection Criteria .................................................................................................. 6 Inclusion Criteria ................................................................................................................................... 6 Exclusion Criteria ................................................................................................................................... 7 Quality Assessment ............................................................................................................................... 7 Summary of Search Results ................................................................................................................ 8 Findings ............................................................................................................................................. 8 Practice Guidelines .......................................................................................................................... 33 Selected Payer Policies ..................................................................................................................... 35 Overall Summary and Discussion ...................................................................................................... 35 Evidence-Based Summary Statement ................................................................................................. 35 Gaps in the Evidence ........................................................................................................................... 36 TECHNICAL REPORT ......................................................................................................................... 37 Clinical Background .......................................................................................................................... 37 Varicose Veins ..................................................................................................................................... 37 Endovascular Laser Ablation ............................................................................................................... 39 Radiofrequency Ablation .................................................................................................................... 40 Selected treatments for varicose veins: Final evidence report Page i WA – Health Technology Assessment April 14, 2017 Sclerotherapy ...................................................................................................................................... 41 Ambulatory Phlebectomy ................................................................................................................... 41 Vein Ligation and Stripping ................................................................................................................. 42 Washington State Agency Utilization and Costs ................................................................................ 43 Review Objectives............................................................................................................................ 46 Scope ................................................................................................................................................... 46 Key Questions ..................................................................................................................................... 46 Search Strategy and Selection Criteria ................................................................................................ 47 Quality Assessment ............................................................................................................................. 49 Search Results ................................................................................................................................. 50 Included Studies .................................................................................................................................. 51 Excluded Studies ................................................................................................................................. 51 Literature Review ............................................................................................................................ 52 Key Question #1: Among patients being treated for varicose veins, what is the clinical effectiveness of endovascular laser ablation, radiofrequency ablation, sclerotherapy, or ambulatory phlebectomy compared with ligation with or without stripping? ................................................. 52 Key Question #2: Among patients being treated for varicose veins, what are the harms associated with endovascular laser ablation, radiofrequency ablation, sclerotherapy, or ambulatory phlebectomy compared with ligation with or without stripping? ................................................. 69 Key Question #3: Among patients being treated for varicose veins, does the effectiveness or risk of adverse events of laser ablation, radiofrequency ablation, sclerotherapy, or ambulatory phlebectomy compared with ligation with or without stripping vary by clinical history (e.g., comorbidities, previous treatment of varicose veins), patient characteristics (e.g., age, sex, body mass index [BMI], smoking history)? ............................................................................................. 76 Key Question #4: What are the cost implications and cost-effectiveness of endovascular laser ablation, radiofrequency ablation, sclerotherapy, or ambulatory phlebectomy compared with ligation with or without stripping for patients being treated for varicose veins? ......................... 76 Practice Guidelines .......................................................................................................................... 78 Selected Payer Policies ..................................................................................................................... 84 Aetna ................................................................................................................................................... 84 Centers for Medicare & Medicaid Services (CMS) .............................................................................
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