Atherectomy for peripheral artery disease

The Health Institute Carlos III (ISCIII) in Spain analyzed the effectiveness and safety of the endovenous ablation of varicose saphenous veins with cyanoacrylate closure system in patients with moderate to severe chronic venous insufficiency compared to surgical procedures, as of saphenous vein stripping, and other endovenous ablation techniques. In the report, published on the website in 2020, it was outlined that despite the limitations found in selected studies, intravenous sealing with cyanoacrylates seems to be a promising alternative to existing treatments, especially in terms of less use of anesthesia and compression bandage, as well as shorter recovery time.

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In February 2020, CAMTÖ started its work on the assessment of peripherally inserted central venous catheter. After the completion of the evaluation process, the report would be published at the web-site of Örebro County Council.

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including peripheral vascular technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for peripheral vascular devices in Europe.

The report presents a summary of the reimbursement situation for procedures of embolization of peripheral vessels (uterine fibroid, prostate, liver, arteriovenous malformations) in Europe. The report covers particles and fluid agents. 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. It is also possible to add analysis in the Czech Republic, Finland, Hungary, Romania, Russia and Turkey.

The report presents a summary of reimbursement situation for invasive procedures for treatment of varicose veins of lower extremities in Europe. Procedure codes for the following interventions will be provided in the analysis: sclerotherapy; catheter-assisted procedures using radiofrequency ablation, laser ablation or mechanochemical ablation; high ligation and vein stripping; phlebectomy; endovenous ultrasound-guided obliteration using cyanoacrylate glue or other agents. 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. It is also possible to add analysis in Czech Republic, Finland, Hungary, Romania, Russia and Turkey.

The 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 January 2019. The decisions were made for eighteen medical devices.

Report presents summary of the reimbursement situation in Europe for peripheral intravascular ultrasound. Analysis covers iliac, femoral and popliteal arteries. Analysis is provided for admitted and day case hospital care. 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.

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.

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.

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.

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.

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.

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).

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).

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.

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.

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.

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.

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.

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.