Transcatheter aortic valve implantation (TAVI)

Series
Aortic valve procedures
Status
Published
Date
Number of report
001

Ask the expert

(we accept only company emails)

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

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

17

Jul 2019

On June 6, 2019, the Swiss Federal Department of Home Affairs (FDHA) has changed the Services Ordinance (OPre/KLV), which determines coverage of health care services in Switzerland. The changes regard mostly the reimbursement rules for various services. Furthermore, there are updates regarding the Health Insurance Law (LAMal/KVG), List of Analyses, List of Medical Aids and Equipment, and clinical coding.

Read more

16

Jul 2019

In June 2019, the Norwegian Institute of Public Health (NIPH) has released an HTA report for TAVI in patients with severe aortic stenosis and intermediate surgical risk commissioned by the National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway. The cost-utility analysis indicated that TAVI was slightly more effective and more costly than open surgery. These findings can help decision makers appraise the intervention against the official priority setting criteria in health care sector applicable in Norway.

Read more

20

May 2019

With the regional decree of April 23, 2019, Tuscany Regional Healthcare has published assessments of six medical devices belonging to various therapeutic areas, including a system for monitoring in heart failure, TAVI, glaucoma drainage system, intravascular lithotripsy system.

Read more

14

May 2019

The report presents a summary of reimbursement situation for use of Embolic Protection Devices during percutaneous cardiac procedures (PCI and TAVI). 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.

Read more

01

Mar 2019

Eleven new DRGs have been added in 2019, while three DRGs have been deleted. The significant changes have been made for disorders of the circulatory organs (MDC 5) and musculoskeletal, skeletal and connective tissue disorders associated with prosthetic surgery (MDC 8). They concern insertion of vagus stimulator, ablation of heart, percutaneous valve replacement, and others.

Read more

20

Feb 2019

On January 31st, 2019, the French High Authority for Health (HAS) has published a new assessment of transcatheter aortic valve implantation (TAVI). The objective of this assessment was to clarify the level of requirements of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in terms of minimal clinical data to provide for the registration of a new TAVI on the LPPR, for the acceptance of a new indication for a TAVI already registered on the LPPR and for renewal of registration of a TAVI registered on the LPPR.

Read more

17

Jan 2019

In late December 2018, the European HTA agency, EUnetHTA, announced the final report of the project OTCA06 - “Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk.”

Read more

11

Jan 2019

Federal Department of Home Affairs (FDHA) released changes in coverage of medical procedures, IVD tests and medical aids in Switzerland. They include extension of coverage for neonatal screening to severe congenital immunodeficiencies, extension of coverage under restrictions for TAVI, gene test for breast cancer, PET, PET / CT, local superficial hyperthermia during tumour treatment, external defibrillator and coverage for sub-urethral tapes for the treatment of stress urinary incontinence in women. Also, changes in the coverage for neonatal screening were introduced.

Read more

04

Sep 2018

At the end of June of 2018, the National Board of Health and Welfare (Socialtyrelsen) has published an updated version of the National clinical guidelines for heart care. The review was conducted for the inclusion of few updated recommendations regarding the management of the coronary heart disease, valvulopathy and arrhythmia.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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).

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

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
(we accept only company emails)