Mechanical thrombectomy for acute ischemic stroke

In February 2020, the Office for Health Technology Assessment (HTA) of Basque Country OSTEBA published an HTA report for efficacy and safety of mechanical thrombectomy (MT) in the treatment of patients with ischaemic stroke beyond 6 hours after onset or with an unknown time of onset. According to the report, the use of MT, together with standard medical treatment (SMT) in such patients, is justified provided that they meet the neuroimaging selection criteria applied to the studies analyzed.

In early September 2019, the Innovation Committee of the Federal Joint Committee (G-BA) has published an overview of new research projects in the area of health services to be funded by the Innovation Fund in the future.

In June 2019, the National Institute for Health and Care Excellence (NICE) published six new interventional procedure guidance, one new Medical technologies guidance for Endocuff Vision for assisting visualisation during colonoscopy, and two new MedTech innovation briefings (for Danis stent for acute oesophageal variceal bleeds, and The OPTIMIZER smart system for managing heart failure).

On the Interterritorial Council that took place March 4th, 2019, the Working Plan for the Spanish Network for Health Technology Assessment was agreed and published. The working plan includes 22 health technology assessment reports, 7 monitoring studies, 9 clinical practice guidelines, and 1 evidence-based product.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in the period July-September 2018 concern various types of devices. In total, 52 decisions were published.

In the second half of July, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance for low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing, fresh fractures at high risk of non-healing, superior capsular augmentation for massive rotator cuff tears, transaxial interbody lumbosacral fusion for severe chronic low back pain and two new Medtech Innovation Briefings for remote ECG interpretation consultancy services for cardiovascular disease and mechanical thrombectomy devices for acute ischaemic stroke.

A 62-page reimbursement report covers mechanical thrombectomy for stroke. 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.

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).

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).

New material codes for neurovascular self-expanding stent retrievers for clot removal (mechanical thrombectomy for stroke) and foam preparation for hysterosalpingosonography were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in July.

The National Board (Socialstyrelsen) has developed a new national guideline for the treatment of stroke with a significant focus on mechanical thrombectomy. MTRC provides an overview of key recommendations, which concern diagnosis and treatment phase using medical technologies.

French National Authority for Health (HAS) has initiated an assessment of organizational impact of mechanical thrombectomy on the system of stroke management in France with objective to find the most adequate way of further introduction of the method into French health care system.

The Forum of Norwegian payers made decision about introduction of three medical technologies: mechanical thrombectomy for stroke, baroreflex activation therapy for resistant hypertension and non-invasive prenatal testing for detection of trisomy 13, 18 and 21.

The procedure will be included into Prescribed Specialized Services. About 8000 patients can benefit from the treatment annually. Other stroke treatments are commissioned by Clinical Commissioning Groups.