Transcatheter aortic valve implantation (TAVI)

Series
Aortic valve procedures
Status
Published
Date
Number of report
001

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Report presents summary of the reimbursement situation in Europe for transcatheter aortic valve implantation (TAVI) for aortic stenosis. Use of both transfemoral and transapical TAVI is reviewed. 

TAVI is well established technology with reimbursement available in all studied European geographies. The main payment models are diagnosis-related group (DRG) for entire hospitalization, add-on reimbursement (England, France, Italy in some regions) and fee for procedure and material (Belgium). All geographies, but Italy, have specific procedure codes for TAVI. Brand-specific reimbursement is only available in Belgium and France, while in other countries reimbursement is established for the class of devices.

Reimbursement differs for different types of access for procedure only in France, Germany and Switzerland. In Germany and Switzerland procedure with transapical access has higher reimbursement.

Complications or stroke specifically do not impact allocation to DRG and reimbursement level in any of studied countries, with exception of France.

Almost every country has implemented certain restrictions to provision of TAVI, which are limited to inoperable or operable patients at high surgical risk in majority of studied geographies.

Manufacturers of the TAVI system include:

  • Abbott (previously - St. Jude Medical) (Portico)
  • Boston Scientific (Lotus)
  • Colibri Heart Valve
  • Direct Flow Medical
  • Edwards Lifesciences (Sapien)
  • JenaValve
  • Medtronic (CoreValve)
  • Symetis
  • Transcatheter Technologies

Report includes essential information about reimbursement and national funding for TAVI, 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
  • Summary of the reimbursement hurdle for medical technology
  • Potential further developments of the reimbursement

Reimbursement information is provided for the following geographies:

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

Table of content

1.    Introduction and summary
2.    Executive summary table
3.    Methodology
4.    Reimbursement analysis in Austria

4.1.    Overview of the reimbursement system
4.2.    Reimbursement for TAVI
4.2.1.    Procedure coding for TAVI
4.2.2.    Diagnosis coding
4.2.3.    Payment mechanism and reimbursement tariffs
4.2.4.    Policy considerations for TAVI
4.2.4.1.    Health technology assessments by LBI-HTA
5.    Reimbursement analysis in Belgium
5.1.    Overview of the reimbursement system
5.2.    Reimbursement for TAVI
5.2.1.    Procedure coding for TAVI
5.2.2.    Payment mechanism and reimbursement tariffs
5.2.3.    Reimbursement framework for TAVI determined by INAMI
5.2.4.    Brand-specific reimbursement for TAVI systems
5.2.5.    Policy considerations for TAVI
6.    Reimbursement analysis in Denmark
6.1.    Overview of the reimbursement system
6.2.    Reimbursement for TAVI
6.2.1.    Procedure coding for TAVI
6.2.2.    Diagnosis coding
6.2.3.    Payment mechanism and reimbursement tariffs
7.    Reimbursement analysis in England
7.1.    Overview of the reimbursement system
7.2.    Reimbursement for TAVI
7.2.1.    Procedure coding for TAVI
7.2.2.    Diagnosis coding
7.2.3.    Payment mechanism and reimbursement tariffs
7.2.4.    Policy considerations for TAVI
7.2.4.1.    National commissioning of TAVI by NHS England
7.2.4.2.    Health technology assessment of TAVI by NICE
7.2.5.    Upcoming changes in TAVI reimbursement 
8.    Reimbursement analysis in France
8.1.    Overview of the reimbursement system
8.2.    Reimbursement for TAVI
8.2.1.    Procedure coding for TAVI
8.2.2.    Diagnosis coding
8.2.3.    Payment mechanism and reimbursement tariffs
8.2.4.    Brand-specific reimbursement for TAVI in France
8.2.5.    Policy considerations for TAVI
8.2.5.1.    Health technology assessments by HAS
9.    Reimbursement analysis in Germany
9.1.    Overview of the reimbursement system
9.2.    Reimbursement for TAVI
9.2.1.    Procedure coding for TAVI
9.2.2.    Diagnosis coding
9.2.3.    Payment mechanism and reimbursement tariffs
9.2.4.    Policy considerations for TAVI
9.2.4.1.    Quality assurance framework for TAVI, determined by G-BA
10.    Reimbursement analysis in Italy
10.1.    Overview of the reimbursement system
10.2.    Reimbursement for TAVI
10.2.1.    Procedure coding for TAVI at national level
10.2.2.    Procedure coding for TAVI at regional level
10.2.3.    Diagnosis coding
10.2.4.    Payment mechanism and reimbursement tariffs at national level
10.2.5.    Payment mechanism and reimbursement tariffs at regional level
11.    Reimbursement analysis in the Netherlands
11.1.    Overview of the reimbursement system
11.2.    Reimbursement for TAVI
11.2.1.    Procedure coding for TAVI
11.2.2.    Diagnosis coding
11.2.3.    Payment mechanism and reimbursement tariffs
11.2.4.    Policy considerations for TAVI
12.    Reimbursement analysis in Norway
12.1.    Overview of the reimbursement system
12.2.    Reimbursement for TAVI
12.2.1.    Procedure coding for TAVI
12.2.2.    Diagnosis coding
12.2.3.    Payment mechanism and reimbursement tariffs
12.2.4.    Policy considerations for TAVI
12.2.4.1.    Assessment of TAVI within national framework of managed introduction of innovations
13.    Reimbursement analysis in Sweden
13.1.    Overview of the reimbursement system
13.2.    Reimbursement for TAVI
13.2.1.    Procedure coding for TAVI
13.2.2.    Diagnosis coding
13.2.3.    Payment mechanism and reimbursement tariffs
13.2.4.    Policy considerations for TAVI
13.2.4.1.    Recommendations for TAVI in the national clinical guidelines
14.    Reimbursement analysis in Switzerland
14.1.    Overview of the reimbursement system
14.2.    Reimbursement for TAVI
14.2.1.    Procedure coding for TAVI
14.2.2.    Diagnosis coding
14.2.3.    Payment mechanism and reimbursement tariffs
14.2.4.    Policy considerations for TAVI
14.2.4.1.    Restrictions for TAVI in the Health Benefit List
15.    Disclaimer

15

Mar 2018

The German Federal Joint Committee (G-BA) has commissioned the Institute for Quality Assurance and Transparency in Health Care (IQTIG) to evaluate the guideline on minimally invasive heart valve interventions with minimum quality standards for hospitals that want to perform transcatheter aortic valve implantation (TAVI) or clip procedures on the mitral valve. The report has to be submitted by December, 2019.

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27

Nov 2017

EUnetHTA has published project plan of rapid assessment of TAVI procedure in patients with intermediate risk. Current plan describes the design and methodology of the assessment, list of involved reviewers, stakeholders and timelines of the project. The final report will be prepared till the end of January 2018.

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22

Nov 2017

The Austrian HTA body LBI-HTA performed a systematic review of health economic evaluations of Transcatheter Aortic Valve Implantation (TAVI) compared to medical treatment and surgical aortic valve replacement for inoperable and operable patients with high or moderate surgical risk. The result of the review have only limited transferability to Austria, and LBI-HTA concluded, that the currently applied selection of patients based on clinical parameters can be considered as good practice.

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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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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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16

Aug 2017

In the second two weeks of July, the National Institute for Health and Care Excellence published one new (FebriDx for C-reactive protein and Myxovirus resistance protein A testing in primary care) and 3 updated Medtech Innovation Briefings, new Diagnostics Guidance for quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care and three new Interventional Procedures Guidance for laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease, transcatheter aortic valve implantation for aortic stenosis and hysteroscopic sterilisation by insertion of intrafallopian implants.

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04

Apr 2017

NICE in the UK has released a consultation document in relation to the TAVI procedure (Interventional Procedure Guidance). Publication of the final guidance, which will replace the guidance from the 2012, is expected in July 2017.

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30

Mar 2017

Our analysis of creation of procedure codes for TAVI in 11 European markets shows different speed in creation of codes, but in general it was a quick process (1.8 years on average). However, in all markets, availability of procedure code did not automatically lead to reimbursement or appropriate reimbursement.

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20

Mar 2017

MTRC has released reimbursement report for transcatheter aortic valve implantation in 11 European countries. Report includes information about procedure coding, payment mechanisms, reimbursement tariffs and policies for TAVI.

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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.

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