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  • Negative Pressure Wound Therapy Home Use

    Draft Evidence Report

    August 17, 2016

    Health Technology Assessment Program (HTA) Washington State Health Care Authority

    PO Box 42712 Olympia, WA 98504-2712

    (360) 725-5126

    www.hca.wa.gov/hta/ shtap@hca.wa.gov

    Health Technology Assessment

    http://www.hca.wa.gov/hta/

  • Negative Pressure Wound Therapy Home Use

    A Health Technology Assessment

    Prepared for Washington State Health Care Authority

    DRAFT REPORT

    August 17, 2016

    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 individuals

    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 August 17, 2016

    Negative Pressure Wound Therapy Home Use: Draft Evidence Report iii

    Table of Contents EVIDENCE SUMMARY .................................................................................................................................... 1

    Summary of Clinical Background .............................................................................................................. 1

    Wound Types of Interest ...................................................................................................................... 1

    Negative Pressure Wound Therapy ...................................................................................................... 1

    Policy Context ........................................................................................................................................... 2

    Summary of Review Objectives and Methods .......................................................................................... 2

    Review Objectives ................................................................................................................................. 2

    Key Questions ....................................................................................................................................... 2

    Methods .................................................................................................................................................... 3

    Search Strategy and Selection Criteria .................................................................................................. 3

    Inclusion Criteria ................................................................................................................................... 3

    Exclusion Criteria ................................................................................................................................... 4

    Quality Assessment ............................................................................................................................... 4

    Summary of Search Results....................................................................................................................... 5

    Findings ..................................................................................................................................................... 5

    Practice Guidelines.................................................................................................................................. 17

    Selected Payer Policies ............................................................................................................................ 19

    Aetna ................................................................................................................................................... 19

    Centers for Medicare & Medicaid Services (CMS) .............................................................................. 19

    Group Health Cooperative .................................................................................................................. 20

    Oregon Health Evidence Review Commission (HERC) ........................................................................ 20

    Regence ............................................................................................................................................... 20

    Overall Summary and Discussion ............................................................................................................ 20

    Evidence-Based Summary Statement ................................................................................................. 20

    Gaps in the Evidence ........................................................................................................................... 22

    TECHNICAL REPORT .................................................................................................................................... 23

    Clinical Background ................................................................................................................................. 23

    Wound Types of Interest .................................................................................................................... 23

    Negative Pressure Wound Therapy .................................................................................................... 24

    Washington State Agency Utilization and Costs ..................................................................................... 29

  • WA Health Technology Assessment August 17, 2016

    Negative Pressure Wound Therapy Home Use: Draft Evidence Report iv

    Review Objectives ................................................................................................................................... 30

    Scope ................................................................................................................................................... 30

    Key Questions ..................................................................................................................................... 30

    Search Strategy and Selection Criteria ................................................................................................ 30

    Quality Assessment ............................................................................................................................. 33

    Search Results ......................................................................................................................................... 34

    Included Studies .................................................................................................................................. 35

    Excluded Studies ................................................................................................................................. 35

    Literature Review .................................................................................................................................... 36

    Key Question #1a: What is the clinical effectiveness of NPWT in the home or outpatient settings for

    treatment of chronic wounds (i.e., venous leg ulcers, arterial leg ulcers, diabetic foot ulcers,

    pressure ulcers, and mixed etiology chronic wounds)? ...................................................................... 36

    Key Question #1b: What is the clinical effectiveness of NPWT in the home or outpatient settings for

    treatment of nonhealing closed or open surgical wounds (i.e., incisions expected to heal by primary

    intention or incisions expected to heal by secondary intention)? ..................................................... 41

    Key Question #2: What are the harms associated with NPWT? ......................................................... 44

    Key Question #3: Does the effectiveness of NPWT or incidence of adverse events vary by clinical

    history (e.g., diabetes), wound characteristics (e.g., size, chronicity), duration of treatment, types of

    devices, or patient characteristics (e.g., age, sex, prior treatments, smoking, or other medications)?

    ............................................................................................................................................................ 48

    Key Question #4: What are the cost implications and cost-effectiveness of NPWT? ........................ 51

    Practice Guidelines.................................................................................................................................. 53

    Selected Payer Policies ............................................................................................................................ 55

    Aetna ................................................................................................................................................... 56

    Centers for Medicare & Medicaid Services (CMS) .............................................................................. 56

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