Angioplasty of arteries of lower extremities for peripheral artery disease

Series
Peripheral vascular interventions
Status
Published
Date
Number of report
012

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Report presents summary of the reimbursement situation in Europe for a group of angioplasty procedures of arteries of lower extremities for peripheral artery disease (plain and drug-eluting balloon angioplasty, stenting using bare metal and drug-eluting stents).

Analysis covers iliac, femoral and popliteal arteries.

Analysis is provided for admitted and day case hospital care.

The following clinical scenarios are considered:

  • Balloon angioplasty as stand-alone procedure
    • Balloon angioplasty using drug-eluting balloon
  • Balloon angioplasty in combination with percutaneous transluminal atherectomy
  • Balloon angioplasty in combination with insertion of stent
    • Insertion of bare metal stent
    • Insertion of drug-eluting stent

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

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

Reimbursement information is provided for the following geographies:

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

Manufacturers of catheters for plain balloon peripheral angioplasty include:

  • AMG International
  • Angiodynamics
  • Balton
  • Boston Scientific
  • BrosMed
  • Cook Medical
  • Cordis
  • CR Bard
  • Degania Silicone
  • Lepu Medical
  • Medtronic
  • Merit Medical
  • MicroPort
  • QTVascular
  • Spectranetics
  • Stron Medical

Manufacturers of catheters for balloon angioplasty using drug-eluting balloon include:

  • Aachen Resonance (ELUTAX SV)
  • B Braun (SeQuent® Please OTW)
  • Bard / Lutonix (LUTONIX Drug Coated Balloon Catheter)
  • Biotronik (Passeo 18 Lux)
  • BostonScientific (Ranger)
  • Cardionovum (Legflow)
  • Cook Medical (Advance 18 PTX)
  • Eurocor Endovascular (Freeway)
  • Medtronic (IN.PACT Admiral DCB)
  • Spectranetics (Stellarex)

Manufacturers of bare metal stents for peripheral stenting include:

  • Abbott Vascular
  • Alvimedica
  • AMG International
  • Andramed
  • B Braun
  • Balton
  • Bentley InnoMed
  • Biosensors International
  • Biotronik
  • Boston Scientific
  • Cook Medical
  • Cordis
  • CR Bard
  • Endocor
  • Eucatech
  • Hexacath
  • InSitu Technologies
  • IVascular
  • Jotec
  • Medinol
  • Medtronic
  • Meril
  • Optimed
  • Rontis
  • Stentys
  • Stron Medical
  • Terumo
  • Vascular Concepts
  • Veryan
  • W.L. Gore

Manufacturers of drug-eluting stents for peripheral stenting include:

  • Abbott Vascular (DYNALINK-E, Xience Prime)
  • Biosensors International (Biomatrix Flex)
  • Boston Scientific (Eluvia)
  • Cook Medical (Zilver PTX Drug-Eluting Peripheral Stent)
  • Cordis (SMART, Cypher)
  • Meril (Meres)
  • Stentys

If you are interested in other reimbursement reports in the peripheral artery field, please, visit report-specific pages for:

Table of content

1.    Introduction and summary
2.    Executive summary table

2.1.    Percutaneous transluminal angioplasty with plain balloon
2.2.    Percutaneous transluminal angioplasty with drug-eluting balloon
2.3.    Percutaneous transluminal angioplasty with insertion of bare metal stent
2.4.    Percutaneous transluminal angioplasty with insertion of drug-eluting stent
3.    Contents
4.    Methodology
5.    Reimbursement analysis in Austria

5.1.    Overview of the reimbursement system
5.2.    Reimbursement for percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease 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 transluminal angioplasty with drug-eluting stent
5.2.4.2.    Percutaneous transluminal angioplasty with drug-eluting balloon 
6.    Reimbursement analysis in Belgium
6.1.    Overview of the reimbursement system
6.2.    Reimbursement for percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease technologies
6.2.1.    Procedure coding 
6.2.2.    Material coding
6.2.3.    Payment mechanism and reimbursement tariffs
6.2.4.    Brand-specific reimbursement for drug-eluting stents and drug-coated balloons
6.2.5.    Policy considerations
6.2.5.1.    Reimbursement framework for percutaneous transluminal angioplasty with insertion of drug-eluting stent determined by INAMI
6.2.5.2.    Reimbursement framework for percutaneous transluminal angioplasty with drug-eluting balloon determined by INAMI
6.2.5.3.    Health technology assessment by Belgian Health Care Knowledge Centre
7.    Reimbursement analysis in Denmark
7.1.    Overview of the reimbursement system
7.2.    Reimbursement for percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease 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 percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease 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 of percutaneous transluminal angioplasty with or without stenting by NHS England 
8.2.4.2.    Health technology assessment of percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease by NICE
8.2.4.3.    Clinical guideline for diagnosis and management of peripheral arterial disease by NICE
9.    Reimbursement analysis in France
9.1.    Overview of the reimbursement system
9.2.    Reimbursement for percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease 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 
9.2.5.    Policy considerations
9.2.5.1.    Drug-eluting balloons
9.2.5.2.    Bare metal stents
9.2.5.3.    Self-expanding drug-eluting stents
10.    Reimbursement analysis in Germany
10.1.    Overview of the reimbursement system
10.2.    Reimbursement for percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease technologies
10.2.1.    Procedure coding 
10.2.2.    Diagnosis coding
10.2.3.    Payment mechanism and reimbursement tariffs in hospital setting
10.2.4.    Payment mechanism and reimbursement tariffs in day case
10.2.5.    Policy considerations
11.    Reimbursement analysis in Italy
11.1.    Overview of the reimbursement system
11.2.    Reimbursement for percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease technologies
11.2.1.    Procedure coding 
11.2.2.    Diagnosis coding
11.2.3.    Payment mechanism and reimbursement tariffs at national level
11.2.4.    Payment mechanism and reimbursement tariffs at regional level
12.    Reimbursement analysis in the Netherlands
12.1.    Overview of the reimbursement system
12.2.    Reimbursement for percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease technologies
12.2.1.    Procedure coding
12.2.1.1.    Procedure coding for intervention performed by surgeon
12.2.1.2.    Procedure coding for interventions performed by radiologist 
12.2.2.    Material coding
12.2.3.    Diagnosis coding
12.2.4.    Payment mechanism and reimbursement tariffs
12.2.4.1.    Payment mechanism and reimbursement tariffs for interventions performed by surgeon
12.2.4.2.    Payment mechanism and reimbursement tariffs for interventions performed by radiologist
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 percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease technologies
13.2.1.    Procedure coding 
13.2.2.    Diagnosis coding
13.2.3.    Payment mechanism and reimbursement tariffs in hospital setting
13.2.4.    Payment mechanism and reimbursement tariffs in day case
13.2.5.    Policy considerations
13.2.5.1.    Assessment within national framework of managed introduction of innovations 
14.    Reimbursement analysis in Sweden
14.1.    Overview of the reimbursement system
14.2.    Reimbursement for percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease technologies
14.2.1.    Procedure coding 
14.2.2.    Diagnosis coding
14.2.3.    Payment mechanism and reimbursement tariffs in hospital setting
14.2.4.    Payment mechanism and reimbursement tariffs in day case
14.2.5.    Policy considerations 
14.2.5.1.    Swedish Drug-elution Trial in Peripheral Arterial Disease trial (SWEDEPAD)
15.    Reimbursement analysis in Switzerland
15.1.    Overview of the reimbursement system
15.2.    Reimbursement for percutaneous transluminal angioplasty with or without stenting for peripheral arterial disease technologies
15.2.1.    Procedure coding 
15.2.2.    Diagnosis coding
15.2.3.    Payment mechanism and reimbursement tariffs in hospital setting
15.2.4.    Payment mechanism and reimbursement tariffs in day case
15.2.5.    Policy considerations 
16.    Disclaimer

24

Sep 2018

The report presents a summary of reimbursement situation for placement of inferior vena cava filter to prevent pulmonary embolism. Permanent and optionally retrievable filters are considered. The only reimbursement within public / statutory health insurance systems is considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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24

Nov 2017

In the first half of November, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (double-mobility cup, meniscal repair system), electrodes for radiofrequency ablation, portable oxygen concentrator, drug–coated balloons and other devices.

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03

Nov 2017

In October, HAS published a set of decisions about add-on reimbursement of medical devices that were assessed by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (foot prosthesis, bone graft substitute), TAVI using Sapien valve, liquid embolic system, remote monitoring system, wound dressing and home oxygen system.

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23

Oct 2017

On 13th of October of 2017, the Ministry of Health of Poland commissioned Agency of Health Technology Assessment and Tariff Systems (AOTMiT) to assess the benefit of angioplasty of arteries of lower extremities (femoral and popliteal) with drug-eluting balloons.

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17

Oct 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September 2017. They include knee and hip prostheses, therapeutic shoes, coronary stents, heart valves, peripheral stents, and balloons.

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28

Sep 2017

MTRC has analyzed timing of decision-making (negotiation about price, final ministerial decision and publication of the decision) after recommendation by CNEDiMTS about expected benefit (AS) and added clinical value (ASA) for invasive non-implantable medical devices reimbursed via LPPR list, title V. Since establishment of the title V program, 5 technologies were added to the List (stent retrievers for stroke; peripheral drug-coated balloons). Time from the recommendation by CNEDiMTS until the start of reimbursement varied from 7 to 13 months (9.4 months on average).

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06

Sep 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2017. They include different types of stents and stent-grafts for multiple indications (coronary, peripheral vascular), mechanical thrombectomy devices for stroke, medical devices applied for treatment of ulcer of venous origin, remote monitoring for Implantable Cardioverter Defibrillator Systems (ICDS).

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04

Sep 2017

There is an ongoing process to change the structure of add-on reimbursement for peripheral vascular stents in France. In July 2017 CNEDiMTS issued additional clarifications about proposed reimbursement requirements for stents and stent-grafts. Read about proposed changes in our post.

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14

Jul 2017

Report provides overview of procedure coding, payment mechanism, reimbursement tariffs and policy considerations for mechanical and pharmacomechanical (AngioJet, Boston Scientific) thrombectomy, catheter-directed and ultrasound-enhanced catheter-directed (EKOS, BTG) thrombolysis in iliac, femoral and popliteal veins in 11 European countries.

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08

Jun 2017

Administrators of the “New Method” program, which is focused on managed introduction of innovations into Norwegian system, have initiated technology assessments of 10 technologies and now have requested manufacturers to make submission of clinical and economic evidence.

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10

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries of lower extremities with stenting using bare metal and drug-eluting stents for peripheral arterial disease in England, France and Germany. Procedure is reimbursed via combination of diagnosis-related group (DRG) and add-on reimbursement in England and France and solely via DRG in Germany.

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08

May 2017

Ministerial decree to enlist Medtronic's IN.PACT Admiral for the LPPR title V for add-on reimbursement was published on 6th of May 2017 in the Official Journal of French Republic. This is not only the first peripheral DCB on the List, but one of the first invasive non-implantable devices to get add-on reimbursement in France.

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01

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.

Read more
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