LBI-HTA reviews patient selection practice for TAVI in Austria

22

Nov 2017

Transcatheter Aortic Valve Implantation (TAVI) has been used for the treatment of patients with severe, symptomatic aortic stenosis for several years. It is a less invasive but high-cost alternative to surgical aortic valve replacement with open heart surgery.

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) is an independent research institution supporting evidence-based and cost-efficient decision-making in Austria. LBI-HTA now performed a systematic review of health economic evaluations of TAVI.

Purpose of the report by LBI-HTA was to review the current policy for selection of patients for TAVI in Austria. For this, health-economic evaluations on the cost-effectiveness of TAVI for patients who are inoperable or operable but with high or moderate surgical risk were investigated.

In the review, LBI-HTA identified a total of 15 health-economic analyses published in English and German between 2007 and 2017. Out of these, 8 studies were assessed with sufficient relevance and quality. The results showed that, for inoperable patients, TAVI was cost-effective compared to Medical Management (1 study). For operable patients, TAVI was cost-effective compared to Standard Management in only 1 of 5 studies and showed controversial results compared to Surgical Aortic Valve Replacement in patients with high surgical risk (4 studies). Sensitivity analyses showed that the results may particularly be influenced by the inclusion of follow-up treatments such as stroke and the TAVI procedure costs.

The LBI-HTA concluded that the cost-effectiveness results are only partially transferable to Austria for following reasons:

  • Only a small number (8 of 15) of evaluations were sufficiently reliable
  • Low robustness of the cost-effectiveness results, as they are highly sensitive to in- and exclusion of cost parameters
  • Austria does not use cost-effectiveness thresholds

Overall, LBI-HTA concludes that the current policy in Austria of selecting patients for TAVI based on clinical parameters can be considered as good practice.

The report by the LBI-HTA is available in German here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

Related news

10

Nov 2020

The Austrian Institute for Health Technology Assessment (AIHTA) is conducting a research project “Framework for reimbursement decisions of digital health technologies (mHealth) and its (retrospective) application on selected examples”. The project started in May 2020, with expected completion in November 2020.

Read more

16

Oct 2020

In late September 2020, the Austrian version of the DRG system (LKF) 2021 model with the relevant supplementary documents was published in Austria. For 2021, the main changes include the addition of sixteen new procedure codes and the introduction of two new procedure codes for billing in the day-case settings, update of cases flat rates, and adjustments of the cases daily component calculation.

Read more

12

Oct 2020

On September 30, 2020, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) published the position that transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis and a high risk of surgery is eligible for reimbursement under basic health insurance package.

Read more

25

Sep 2020

In late august 2020, the Basic Package Advisory Committee of the Dutch Health Care Institute (ZIN) concluded that Transcatheter Aortic Valve Implantation (TAVI) complies with the ‘state of the art and science’ and is therefore effective.

Read more

22

Sep 2020

Earlier in September 2020, the Austrian Institute for Health Technology Assessment (AIHTA) released a synopsis of the ongoing research project “Reimbursement decisions for medical procedures in Austria: An analysis of factors – besides clinical evidence – influencing reimbursement decisions for the hospital benefit catalog 2010-2020.”

Read more

02

Sep 2020

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) issued an updated report on the PET/PET-CT evidence for need-based planning in Austria.

Read more

25

Aug 2020

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) published updated evaluations of medical procedures previously assessed. Technologies that were revised are leadless pacemaker for right ventricle pacing and extracorporeal cytokine hemadsorption therapy in patients with sepsis or SIRS.

Read more

11

Aug 2020

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) published five decision support documents. The assessed technologies included implantation of a wireless pulmonary artery pressure sensor in patients with advanced heart failure, intrauterine ultrasound-guided transcervical radiofrequency ablation, percutaneous transvascular implantation of a coronary sinus reducing stent, radiofrequency-induced intravesical chemohyperthermia for non-muscle invasive bladder cancer, and Vascular photodynamic therapy with Padeliporfin (Tookad® solution).

Read more

22

Jul 2020

On June 16, 2020, HTA Austria – Austrian Institute for Health Technology Assessment (AIHTA), issued an updated report on the indications for proton and carbon ion therapy with an overview of confirmed indications, indications that are only recommended under clinical research, and excluded indications.

Read more

30

Jun 2020

In early June 2020, the Austrian Ministry of Health published recommendations for further actions in the establishment of systematic HTA in the Austrian healthcare system, which were developed by the Federal Target Steering Commission in April.

Read more

29

Jun 2020

On June 23, 2020, the Swiss Federal Office of Public Health (FOPH) announced several changes in the coverage of benefits that will take place soon. They regard transcatheter aortic valve implantation (TAVI), adjustments in the List of Aids (EMAp/MiGeL) (including reimbursement for CPAP devices and mechanical ventilation at home, and adjustments in the List of Analyses (AL/EA).

Read more

22

May 2020

Thirteen new MELs (DRGs) were introduced into the LKF 2020 model for the inpatient and outpatient settings.

Read more

18

May 2020

Twenty-five new diagnosis codes were implemented and changed in the Austrian version of ICD-10 2020 of the LKF model 2020

Read more

29

Apr 2020

Sixty-three new procedure codes and other changes were introduced into the service catalog of the LKF model 2020 for the inpatient and outpatient area in Austria.

Read more

13

Apr 2020

On March 27, 2020, the BMSGPK release the notes with the rules on diagnosis coding and administrative documentation for COVID-19 in hospitals as part of the project "Performance-based hospital financing (LKF)."

Read more

10

Mar 2020

On January 1, 2020, as a part of healthcare reform in Austria, the Austrian health insurance fund (Die Österreichische Gesundheitskasse (ÖGK)) was created by merging the nine former regional health insurance funds. The ÖGK is based in Vienna.

Read more

27

Jan 2020

The Swiss Services Ordinance (KLV/OPre) is the document that defines the health care services which are covered by the compulsory health insurance in Switzerland. It is updated annually (with more frequent updates possible); thus, the 2020 version is released. Changes concern autologous transplantation of chondrocytes, extracorporeal photopheresis, transcatheter aortic valve implantation, ultrasound therapy focused on the pallidum, thalamus and subthalamus, CAR-T cell therapies, tomography with positron emission (PET/CT), stereotactic radiation therapy (photons) of wet age-related macular degeneration.

Read more

23

Dec 2019

On the 10th of December 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) has released a report on the implementation of an HPV screening test for the early detection of cervical cancer in women as a measure of cervical cancer prevention. The recommendations are positive.

Read more

04

Oct 2019

On the 2nd of September 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) has released a report on guideline recommendations comprising screening for diabetes mellitus.

Read more

18

Sep 2019

In August 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) published four decision support documents. The assessed technologies are osteochondral allograft transplantation, allograft for anterior and posterior cruciate ligament reconstruction, human dermal allograft, and 177 Lutetium.

Read more

05

Sep 2019

In August 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) published updated evaluations of medical procedures previously assessed. Technologies that were revised are The Barricaid® device for annulus Fibrosus Repair after lumbar discectomy, single-step scaffold-based treatment (AMIC) and two-step scaffold-based treatment (MACI), radiofrequency denervation and electrical stimulation of the hypoglossal nerve.

Read more

30

Aug 2019

Technical overviews include details of application processes for procedure codes and payments (e.g. DRG), inclusion into health benefit catalogs. Overviews are available as presentations in Acrobat PDF.

Read more

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

01

Jul 2019

Seminars on hospital reimbursement system for the Netherlands and Russia were added to the online school, as well as the webinar for the Austrian system. MTRC online school is the most cost-effective way to learn about reimbursement systems in a structured way.

Read more

14

Jun 2019

In early May 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published a health technology assessment on robot-assisted surgery in thoracic and visceral indications as part of the EUnetHTA work.

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

04

Feb 2019

In January 2019, the Austrian HTA body Ludwig-Boltzmann Institute (LBI) has published the update of their decision support document (DSD) 103, which concerns the wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk. The authors state that further research is necessary for the development of reliable conclusions.

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

26

Oct 2018

In October 2018, the Austrian HTA body, the Ludwig-Boltzmann Institue (LBI), published the update on the PET/PET-CT topic. The report was done together with the Berlin Technical University.

Read more

22

Oct 2018

On 6th of September, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) has released a report on external stimulation of the trigeminal nerve for the prevention and acute treatment of an episodic and chronic migraine. The method was not recommended for inclusion into catalogue of hospital benefits.

Read more

19

Oct 2018

In mid-August 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published a health technology assessment in which they have assessed the efficacy and safety of stereotactic radiotherapy (Cyberknife®), proton beam therapy and irreversible electroporation (Nanoknife®) for localized prostate cancer (PCa). It was concluded, there is inadequate and insufficient evidence to show that three evaluated technologies have either a positive impact on survival and quality of life or the ability to prevent or delay prostatectomy.

Read more

15

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published HTA of meniscal allograft transplantation for post-meniscectomy syndrome in Austria. It was concluded that there is not enough evidence demonstrating benefits in order to include MAT into the Austrian benefit catalogue.

Read more

09

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published HTA of allogeneic mesenchymal stem cells for Crohn’s disease-associated complex perianal fistulas. Currently, inclusion into Austrian catalogue of benefits was not recommended with reevaluation in 2022.

Read more

05

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an evaluation of baroreceptor activation therapy for treatment-resistant hypertension. The authors concluded that there is no sufficient evidence to conclude on effectiveness or safety of BAT and thus inclusion of the procedure into the Austrian benefit catalogue is not recommended. There are currently three RCTs going on, and their results may bring new evidence.

Read more

01

Oct 2018

In mid-August 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published an evaluation of efficacy and safety of carbon ion beam radiotherapy (CIRT) for twelve oncological indications.

Read more

28

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an assessment of left atrial appendage closure to prevent stroke to determine national coverage of the procedure. Considering this evidence, the authors do not recommend the inclusion in the hospital benefit catalogue, neither for percutaneous left atrial appendage occlusion nor for surgical closure using a special clip.

Read more

24

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) released an assessment of the subcutaneous implantable cardioverter defibrillator to determine coverage of the service. Authors concluded that evidence is insufficient to make conclusions about the comparative effectiveness of subcutaneous and transvenous ICDs. However, a substantially lower risk for lead complications in patients treated with subcutaneous ICD.

Read more

21

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an HTA report on efficacy and safety of endobronchial valve implantation for emphysema. The authors have concluded that the intervention is more effective but less safe than standard therapy in selected patients with severe emphysema. Inclusion in the national service catalogue is only recommended with restrictions.

Read more

17

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an update of the HTA of high-intensity focused ultrasound (HIFU) for the treatment of prostate cancer. The report did not find the evidence of benefits of the treatment vs comparative treatments. The inclusion of the method hospital benefit catalogue was currently not recommended.

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

29

Jun 2018

The Ludwig Boltzmann Institute (LBI-HTA), the Austrian HTA body, develops health technology assessments of medical technologies to support decision-making about coverage of these methods in Austrian public reimbursement system. MTRC summarized the list of reports to be published by LBI-HTA until the end of 2018.

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

01

Jun 2018

European Med Tech and IVD Reimbursement Consulting Ltd. released a report, which identifies and provides an overview of the innovative payment schemes for medical devices and in-vitro diagnostic tests in European countries. The report was supported by the grant from the Med Tech Europe. Access the full version of the report at our web-site.

Read more

30

May 2018

In mid-May 2018, the Basque office for Health Technology Assessment, OSTEBA, has published a rapid assessment report on treating prostate cancer with high-intensity focused ultrasound. The article is published under EUnetHTA framework.

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

07

Feb 2018

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) released seven decision support documents in 2017. In these, three technologies were recommended for inclusion into the national benefit catalogue. The rest was preliminarily not recommended for inclusion. HTA by LBI-HTA have indirect but strong connection to decision making about funding by the Ministry of Health.

Read more

09

Jan 2018

The new Diagnosis Related Group (DRG) system, called “LKF system” in Austria came into effect on January 1st 2018. It is used for the reimbursement, documentation and cost data collection of inpatient and day case services in Austrian hospitals. Compared to the last version, the LKF system for 2018 includes two newly established procedure groups (Oncological Immunotherapy and Transcranial Magnetic Stimulation) as well as several new procedures and changes in the association of procedures to specific groups. See details in the MTRC report.

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

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

26

Sep 2017

Austrian Ministry of Social Affairs engaged London School of Economics to undertake efficiency review of country’s social insurance system. Policy recommendations presented in the report include harmonisation of benefits (dentistry, non-medical services, medical aids and medical therapeutic devices), the introduction of an agency for quality assurance and modernisation of outpatient care.

Read more

21

Sep 2017

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) released results of a re-evaluation of percutaneous volume reduction of the intervertebral disk with a focus on chemolucleolysis. Based on current evidence, chemonucleolysis was recommended for inclusion into health benefit catalogue in Austria while percutaneous nucleotomy and percutaneous laser disc decompression were currently not recommended.

Read more

18

Sep 2017

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) released results of re-evaluation of leadless pacemakers for right ventricular pacing. Due to lack of comparative evidence vs conventional pacemakers, leadless pacemakers were not recommended for inclusion into health benefit catalogue in Austria.

Read more

05

Sep 2017

Ludwig Boltzmann Institute HTA evaluated EST for GERD and found the current evidence insufficient to recommend its inclusion into health benefit catalogue. Reevaluation is recommended in 2022 when more evidence becomes available.

Read more

17

Aug 2017

In 2017, PAE was evaluated by the Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) to define whether evidence for this minimally invasive procedure can be sufficient for inclusion into benefit catalogue. Within this research work, evidence in relation to efficacy and safety of PAE was assessed in comparison to transurethral resection of the prostate (TURP) and open prostatectomy. Based on the results of literature review, LBI-HTA did not recommend PAE for inclusion into benefit catalogue in Austria. LBI-HTA recommended re-evaluating PAE procedure in the 2021 year when new potential evidence is available.

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

08

Aug 2017

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) has published report with results of systematic literature review of application extracorporeal cytokine adsorption therapy (ECAT) for treatment and prevention of sepsis or systemic inflammatory response syndrome (SIRS). Considered evidence was assessed as insufficient to prove that ECAT is effective and safe procedure in patients with sepsis, septic shock and SIRS. Therefore, ECAT is currently not recommended for inclusion into the benefit catalogue.

Read more

28

Jul 2017

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) has published results of systematic literature review of evidence in relation to efficacy and safety of radiofrequency ablation for patients with metastatic spinal lesions. In conclusion, LBI-HTA recommended radiofrequency ablation of spinal metastatic lesions for inclusion in benefit catalogue with restrictions.

Read more

09

May 2017

Ludwig Boltzmann Institute - HTA conducted a budget impact analysis on request from the Federal Ministry of Health and Women (BMGF) for testing of TSH as screening for hypothyroidism, urine culture as screening for asymptomatic bacteriuria and ultrasound screening for foetal anomalies.

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