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. 

Sample pages are provided for an older version of the report. Before delivery to the client, the report is updated to the current state (e.g., 2022 coding, tariffs, and policy considerations). 

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

It is also possible to add analysis in Czech Republic, Finland, Hungary, Romania, Russia and Turkey.

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

10

Nov 2022

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in October 2022. Fourteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular, neurovascular, orthopedic, and ENT devices, as well as medical aids.

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09

Dec 2021

In November 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous implantation of pulmonary artery pressure sensors in chronic heart failure and coronary sinus narrowing device implantation for refractory angina), one new Medical Technologies Guidance (Synergo for non-muscle-invasive bladder cancer), one new Diagnostic Guidance (SeHCAT for diagnosing bile acid diarrhea), and four new Medtech Innovation Briefings (clonoSEQ for minimal residual disease, CerebAir for continuous EEG monitoring, 24/7 EEG SubQ for epilepsy, Paige Prostate for prostate cancer). Also, three new clinical guidelines were published, and six were updated.

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26

Nov 2021

In early-mid November 2021, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for early benefit assessment for two new cardiovascular technologies (Revivent TC™ by BioVentrix and Trilogy™ Heart Valve System by JenaValve Technology) in heart failure, and aortic valve insufficiency and stenosis, respectively.

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16

Nov 2021

In late October 2021, the BfArM (Federal Institute for Drugs and Medical Devices) has published the final version of the 2022 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in outpatient and inpatient care.

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06

Jul 2021

In June 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (laser lithotripsy for difficult-to-treat bile duct stones and percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve), one new Medical Technologies Guidance (Plus Sutures for preventing surgical site infection), and four new Medtech Innovation Briefings (RapidAI for analyzing CT/MRI brain scans, WoundExpress, Magtrace and Sentimag, and SYNE-COV). Also, four clinical guidelines were updated, and two new published.

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