Combined report for minimally invasive and transcatheter mitral valve repair and replacement procedures for mitral regurgitation

Series
Mitral valve procedures
Status
Published
Date
Number of report
002

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Report presents summary of the reimbursement situation in Europe for all developed or currently under development minimally invasive (transapical approach via mini-thoracotomy) and transcatheter mitral valve repair and replacement procedures for mitral regurgitation.

Altogether, eight procedures are included into the report:

  • Minimally-invasive mitral valve repair with creation of artificial cordae tendonae for mitral regurgitation
  • Minimally-invasive reshaping of heart geometry for mitral regurgitation
  • Minimally-invasive replacement of mitral valve for mitral regurgitation
  • Transcatheter annuloplasty ring for mitral regurgitation
  • Transcatheter mitral annuloplasty using implant placed in the coronary sinus for mitral regurgitation
  • Transcatheter mitral valve leaflet repair using mitral clips for mitral regurgitation
  • Transcatheter mitral valve repair using mitral annulus plication for mitral regurgitation
  • Transcatheter mitral valve replacement

    Report includes essential information about reimbursement and national funding for mitral technologies, including:

    • Brief overview of reimbursement system for medical devices
    • Procedure coding for mitral technologies
    • Diagnosis coding
    • Payment mechanism for mitral technologies
    • Reimbursement tariffs for mitral technology
    • Restrictions in indications or scenarios for use of mitral technologies
    • Policy considerations by payers and policy-makers about mitral technologies

    Reimbursement information is provided for the following geographies:

    • Austria
    • Belgium
    • Denmark
    • England (UK)
    • France
    • Germany
    • Italy
    • Netherlands
    • Norway
    • Sweden
    • Switzerland

    Manufacturers and developers of the minimally invasive mitral valve repair and replacement systems include:

    • Abbott Vascular (MitraClip, Tendyne valve)
    • Caisson Interventional (Caisson Transcatheter Mitral Valve System)
    • Cardiac Dimensions (Carillon Mitral Contour System)
    • Cardiosolutions (Mitra-Spacer)
    • Cephea
    • Coramaze (Mitramaze system)
    • Direct Flow Medical
    • Edwards Lifesciences (SAPIEN XT valve, Cardioband, CardiAQ-Edwards Transcatheter Mitral Valve, Fortis transcatheter mitral valve)
    • Gorman Cardiovascular Research Group
    • Guided Delivery Systems
    • Harpoon medical (Harpoon Medical device)
    • HighLife (HighLife transcatheter mitral valve replacement device)
    • Mardil Medical (VenTouch System)
    • Medtentia (CathHELIX)
    • Medtronic (TMV)
    • Micro Interventional Devices (Permavalve)
    • Millipede
    • Mitralign (Mitralign Percutaneous Annuloplasty System)
    • MitrAssist
    • Mitre Medical (Mitral Touch)
    • MVRx (ARTO System)
    • NaviGate Cardiac Structures (NAVI System)
    • Neochord (NeoChord DS1000 System)
    • Neovasc (Tiara device)
    • Symetis
    • TransCardiac Therapeutics (MitraFlex system)
    • Transcatheter Technologies

    Table of content

    1.    Introduction and summary
    2.    Executive summary table
    2.1.    Minimally invasive mitral valve repair with creation of artificial chordae tendonae
    2.2.    Minimally invasive replacement of mitral valve
    2.3.    Minimally invasive reshaping of heart geometry
    2.4.    Transcatheter annuloplasty ring
    2.5.    Transcatheter mitral annuloplasty using implant placed in the coronary sinus
    2.6.    Transcatheter mitral valve leaflet repair using mitral clips
    2.7.    Transcatheter mitral valve replacement
    2.8.    Transcatheter mitral valve repair using plication of the mitral annulus 
    3.    Contents
    4.    Methodology
    5.    Reimbursement analysis in Austria

    5.1.    Overview of the reimbursement system
    5.2.    Reimbursement for mitral valve repair and replacement technologies
    5.2.1.    Procedure coding
    5.2.2.    Diagnosis coding
    5.2.3.    Payment mechanism and reimbursement tariffs
    5.2.4.    Health technology assessment by LBI-HTA
    5.2.4.1.    Percutaneous mitral valve interventions using a mitral clip
    5.2.4.2.    Transapical mitral valve-in-valve implantation
    6.    Reimbursement analysis in Belgium
    6.1.    Overview of the reimbursement system
    6.2.    Reimbursement for mitral valve repair and replacement technologies
    6.2.1.    Procedure coding 
    6.2.2.    Material coding
    6.2.3.    Payment mechanism and reimbursement tariffs
    6.2.4.    Policy considerations
    6.2.4.1.    Reimbursement framework for transcatheter mitral valve leaflet repair using mitral clips   
    determined by INAMI
    6.2.4.2.    Brand-specific reimbursement for mitral clip system
    7.    Reimbursement analysis in Denmark
    7.1.    Overview of the reimbursement system
    7.2.    Reimbursement for mitral valve repair and replacement technologies
    7.2.1.    Procedure coding 
    7.2.2.    Diagnosis coding
    7.2.3.    Payment mechanism and reimbursement tariffs
    8.    Reimbursement analysis in England
    8.1.    Overview of the reimbursement system
    8.2.    Reimbursement for mitral valve repair and replacement technologies
    8.2.1.    Procedure coding 
    8.2.2.    Diagnosis coding
    8.2.3.    Payment mechanism and reimbursement tariffs
    8.2.4.    Policy considerations 
    8.2.4.1.    National commissioning by NHS England
    8.2.4.2.    National commissioning of percutaneous mitral valve leaflet repair for mitral regurgitation by NHS England
    8.2.4.3.    Health technology assessment by NICE

    9.    Reimbursement analysis in France
    9.1.    Overview of the reimbursement system
    9.2.    Reimbursement for mitral valve repair and replacement technologies
    9.2.1.    Procedure coding 
    9.2.2.    Diagnosis coding
    9.2.3.    Payment mechanism and reimbursement tariffs
    9.2.4.    Brand-specific reimbursement for mitral clip system 
    9.2.5.    Policy considerations
    9.2.6.    Coverage with evidence development
    9.2.6.1.    Transcatheter mitral valve leaflet repair using mitral clips for mitral regurgitation
    9.2.6.2.    Minimally invasive mitral valve repair with creation of artificial chordae tendonae for mitral regurgitation
    10.    Reimbursement analysis in Germany
    10.1.    Overview of the reimbursement system
    10.2.    Reimbursement for mitral valve repair and replacement technologies
    10.2.1.    Procedure coding 
    10.2.2.    Diagnosis coding
    10.2.3.    Payment mechanism and reimbursement tariffs
    10.2.4.    Policy considerations
    11.    Reimbursement analysis in Italy
    11.1.    Overview of the reimbursement system
    11.2.    Reimbursement for mitral valve repair and replacement technologies
    11.2.1.    Procedure coding at national level
    11.2.2.    Procedure coding at regional level (Emilia-Romagna region)
    11.2.3.    Diagnosis coding
    11.2.4.    Payment mechanism and reimbursement tariffs at national level
    11.2.5.    Payment mechanism and reimbursement tariffs at regional level
    11.2.6.    Policy considerations
    12.    Reimbursement analysis in the Netherlands
    12.1.    Overview of the reimbursement system
    12.2.    Reimbursement for mitral valve repair and replacement technologies
    12.2.1.    Procedure coding 
    12.2.2.    Material coding
    12.2.3.    Diagnosis coding
    12.2.4.    Payment mechanism and reimbursement tariffs
    12.2.5.    Policy considerations
    12.2.6.    Health technology assessment by National Healthcare Institute
    13.    Reimbursement analysis in Norway
    13.1.    Overview of the reimbursement system
    13.2.    Reimbursement for mitral valve repair and replacement technologies
    13.2.1.    Procedure coding 
    13.2.2.    Diagnosis coding
    13.2.3.    Payment mechanism and reimbursement tariffs
    13.2.4.    Policy considerations 
    14.    Reimbursement analysis in Sweden
    14.1.    Overview of the reimbursement system
    14.2.    Reimbursement for mitral valve repair and replacement technologies
    14.2.1.    Procedure coding 
    14.2.2.    Diagnosis coding
    14.2.3.    Payment mechanism and reimbursement tariffs
    14.2.4.    Policy considerations 
    14.2.4.1.    Recommendations for transcatheter mitral valve leaflet repair using mitral clips in the national clinical guidelines
    15.    Reimbursement analysis in Switzerland
    15.1.    Overview of the reimbursement system
    15.2.    Reimbursement for mitral valve repair and replacement technologies
    15.2.1.    Procedure coding 
    15.2.2.    Diagnosis coding
    15.2.3.    Payment mechanism and reimbursement tariffs
    15.2.4.    Policy considerations 
    15.2.4.1.    Restrictions for percutaneous interventional treatment of severe mitral valve insufficiency in the Health   Benefit List
    15.2.4.2.    The Swiss Mitraclip Registry
    16.    Disclaimer

    11

    Jun 2018

    On 11th May, the Italian Ministry of Health announced from its website that five new Med Tech-related HTA documents are available for public consultation. See the details in the MTRC post.

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    20

    Nov 2017

    Annual report from the Italian Society of Interventional Cardiology (GISE) shows increasing trends in procedural volume of percutaneous coronary interventions (PCI), transcatheter aortic valve implantations (TAVI), mitral clip implantations, closure of left atrial appendage (LAA) and patent foramen ovale (PFO).

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    04

    May 2017

    Check out reimbursement summary for the most established transcatheter mitral valve repair procedure in England, France and Germany. Reimbursement is established in Germany and France (for one indication). It is in process to be established in England and in France (for other indications).

    Read more

    25

    Apr 2017

    The procedure can be coded in Austria, Denmark, England, Germany, Italy, Netherlands, Norway, Sweden and Switzerland, so payment mechanism is in place, even with an inadequate tariff in some countries. In countries where the procedure is not coded, it cannot be reimbursed. Despite available reimbursement mechanism, funding has not been established yet in majority of geographies.

    Read more

    10

    Apr 2017

    Reports presents summary of the reimbursement situation in Europe for all developed or currently under development minimally invasive (transapical approach via mini-thoracotomy) and transcatheter mitral valve repair and replacement procedures for mitral regurgitation.

    Read more

    15

    Mar 2017

    MTRC is working on release of 9 reimbursement reports for medical technologies during March 2017, including report for transcatheter aortic valve replacement and eight minimally invasive mitral valve repair and replacement procedures.

    Read more
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